Industry Leaders in
Clinical Hemp Research
Over $40 Million Committed in Clinical Research to Date
When you choose Ananda Professional, you’re buying much more than just a product. You’re helping support multiple clinical trials for CBD – the first of their kind.
These studies are the missing link to gain FDA approval for CBD – a step that would bring regulation (and therefore certainty) to the CBD industry.
This will also elevate CBD and hemp into their rightful roles as powerful, safe, and effective alternative treatment options to mainstream medications.
We reinvest money from every purchase to advance clinical evidence for CBD – helping customers, farmers, and CBD companies alike.
Why Our Research is Vital
1. Clinical evidence is essential to gain FDA approval for CBD, allowing its use as a true medicinal substance
2. High-quality clinical trials verify the usefulness of CBD for various ailments, eliminating ‘snake-oil syndrome’
3. With the recent relegalization of CBD, studying it gives us insight to how it works
4. Completing this research means millions of people can use CBD for health conditions, forgoing more dangerous/addictive alternatives
$40M+
Committed in research to advance the clinical evidence of hemp extract
8
Clinical trials to support the legitimacy of Ananda Professional Products
30+
Quality control checks and highest lab testing standards in the hemp industry
Research Studies
Opioid Reduction
Chronic pain is highly prevalent in most of the industrialized nations around the world. Despite the documented adverse effects, opioids are widely used for pain management. Cannabinoids, and specifically Cannabidiol, is proposed as an opioid alternative, having comparable efficacy with better safety profile.

- Study Focus: Opioid Reduction
- Product Studied: Full Spectrum Softgels
- Research Institution: Murphy Clinic
- Patient Population: Chronic Opioid
- Location: Louisville, KY
- Type/Phase: Prospective Cohort Study
- Status: Complete
Evaluation of the effects of CBD hemp extract on opioid use and quality of life indicators in chronic pain patients: a prospective cohort study
Introduction
Chronic pain is a major cause of disability worldwide with a prevalence rate of 15% to 30% in the general adult population, and more than 500 billion dollars annual costs in the United States. Unfortunately, multiple reports are showing a lack of satisfactory results with available pharmacotherapy with less than 70% of patients having pain relief [1]. Currently, opioids are the mainstay for pain control for most cases including, neuropathic and cancer pain. Nonetheless, the inherent adverse events of opioids are representing major concerns [2]. All too often, these patients become dependent on opioid medications, which carry a risk of tolerance and subsequent physical dependence and multiple adverse effects such as somnolence and constipation, and the potential of death from an overdose [3,4]. Therefore, enormous efforts are exerted to find additional approaches and to provide alternative options with a better safety profile and comparable efficacy.
Cannabis, the plant source of cannabinoids (CB), have been used for millennia for different purposes such as pain control and stress relief. Recently, the delineation of the endocannabinoid system and CB receptors in humans has paved the road for broader applications [5]. Their natural source and the widespread use besides its lower risk of addiction or dependency and relative safety have flagged them for in-depth investigation for potential therapeutic roles. Two molecules have beenof high-interest: cannabidiol (CBD) and tetrahydrocannabidiol(THC).
Recent evidence highlights cannabinoids’ efficacy and safety for pain control. Whiting et al. analyzed 28 clinical trials evaluating cannabinoids in pain control, concluding that there is a moderate-quality evidence that cannabinoids may result in marked pain reduction [7]. This was consistent with its effect on neuropathic pain where cannabinoids were effective in pain relief [8,9]. National Academies of Science, Engineering, and Medicine conducted an extensive systematic review toevaluate cannabinoids, stating that there is ‘extensive evidence’ of cannabinoids’ efficacy in pain relief with good tolerability [10].
Besides its potential direct effects on pain, cannabinoids are suggested to have a role in reducing opioid intake [11,12]. A recent report has highlighted the lower mortality from opioids’ overdose in states with medical cannabis legalization. Similarly, Medicare prescriptions’ reports revealed reduced opioids’ use and their consequent adverse events in the United States (U.S.) with legalized cannabis access [13]. In addition, cannabinoids use may mitigate the escalation of opioid doses in patients with chronic pain with a substantial reduction in opioid intake [14].
The above studies reference the effects of both THC and CBD, the two most abundant and frequently used cannabinoids. THC is a psychogenic molecule responsible for eliciting a ‘high’ sought out in recreational marijuana use. CBD is not intoxicating and therefore possesses an arguably better safety profile than THC [15–17]. Because of these differences in intoxication and abuse potential, the THC and CBD experience varying regulatory paths. Despite increasing state-level legalization, cannabis plants with higher levels (>0.3%) of THC are considered ‘marijuana’ and are federally illegal in the U.S [18]. Low THC (<0.3%) cannabis plants, known as hemp, and its extracts have been recently deemed federally legal in the U.S. via pilot programs in Section 7606 of the 2014 Farm Bill, subsequently made permanent via the 2018 Farm Bill [19–21]. Therefore, hemp-derived cannabis extracts, low in THC and high in CBD, have become increasingly available as over-thecounter products and subject to widespread consumer use across diverse populations [22].
Aiming to control the opioid epidemic, CBD has been investigated for its potential to reduce the addiction risk and physiological dependence features of opioid use while subsequently managing pain [23]. Preclinical models demonstrate CBD’s ability to decrease relapse risk by reducing opioid seeking behavior [24]. Early human trials confirm CBD’s potential in reducing opioid withdrawal symptoms [25]. A recent survey study concluded that 44% of hemp CBD users reported it helped reduce the use of their opioid pain medication [25]. CBD was found to reduce the craving, anxiety and psychological manifestations significantly in drug-abstinent individuals with previous opioid dependency [26,27]. Emerging literature supports evidence for CBD in pain relief and opioid reduction, but no studies to date have evaluated the effects of readily available hemp CBD in chronic pain and opioid use in a single cohort.
In the present study, we aim at investigating the impact of hemp CBD use on opioid use in chronic pain, disability, physical and psychosocial symptoms, sleep, and motivation to taper opioids. We believe that such a study will fill the existing gap and highlight potentially applicable roles for CBD therapeutic indications.
Methods
Study design and ethical considerations
Our study is a prospective, single-arm cohort study that was carried out at Murphy Pain Center, U.S. The study was granted an Institutional Review Board approval from Advarra. All study procedures were conducted in accordance with the declaration of Helsinki. In addition, all enrolled participants had to sign an IRB approved informed consent form at a standard of care visit. For confidentiality, all participants’ data have been coded and stored separately from participants’ identifiers and contact information. The crosswalk between the study ID and participant identifiers has been stored separately from participant data in a password-protected file within a password-protected folder on a secure server system.
Our study is a prospective, single-arm cohort study that was carried out at Murphy Pain Center, U.S. The study was granted an Institutional Review Board approval from Advarra. All study procedures were conducted in accordance with the declaration of Helsinki. In addition, all enrolled participants had to sign an IRB approved informed consent form at a standard of care visit. For confidentiality, all participants’ data have been coded and stored separately from participants’ identifiers and contact information. The crosswalk between the study ID and participant identifiers has been stored separately from participant data in a password-protected file within a password-protected folder on a secure server system.
Participants’ recruitment
Between September and December 2018, patients were informed about the study aims and procedures at their standard care visits at Murphy Pain Center. Patients were enrolled if they met the following eligibility criteria: (1) age between 30 and 65 years old, (2) has moderate to severe chronic pain for at least 3 years, and (3) has been stable on opioids for at least 1 year (defined as less than 10% change in its severity). The Morphine Equivalent Daily Dose (MEDD) of the administered opioid had to be at least 50 to be enrolled in the study. Participants were excluded if they had (1) any history of substance use disorder, (2) any psychotic disorder, (3) abnormal drug screen over the last 12 months, (4) history of nonfatal overdose, (5) any epileptic activity in the last 12 months, (6) incapacitating systemic disorder (cardiac, renal or hepatic), or (7) any known allergy to cannabis-based products.
CBD-rich hemp-extract use
Participants were offered a free sixty-count bottle of hempderived (15 mg), CBD-rich soft gels at baseline, and weeks 4, and 8, which were provided for free by Ananda Professional. Each soft gel contained 15.7 mg CBD, 0.5 mg THC, 0.3 mg cannabidivarin (CBDV), 0.9 mg cannabidiolic acid (CBDA), 0.8 mg cannabichrome (CBC), and >1% botanical terpene blend. Participants were educated on safe CBD use, and ultimately elected whether or not to use CBD and self-titrated their dose of CBD. Of the 97 participants who completed the study, 94 chose to use the CBD soft gels. Almost all participants (91) used two soft gels (~30 mg) daily. One participant supplemented his free bottle of CBD soft gels and consumed four soft gels (~60 mg) daily. Two participants reported using only one soft gel (~15 mg) daily.
Three participants chose not to use CBD. Two initiated the CBD but reported the adverse effect of drowsiness and stopped using the soft gels. One participant declined CBD and expressed his concern in that he could not afford to pay out of pocket for the product after the end of the study if it was successful. One participant reported that CBD ‘made her heart race’ and combined twice-daily dosing into one dose to manage the side effect. One participant reported nausea from CBD but continued using the product. One participant reported ‘heart burn and dry mouth’ after initiating CBD. One participant reported CBD increased her nighttime anxiety and disturbed sleep. No significant adverse events were reported.
Outcomes’ assessment and follow-up points
The primary outcome of the study was the effectiveness of the CBD-rich extract to reduce the dependence on opioids for pain control measured via the opioids’ dose. Secondary outcomes included the pain-related quality of life (QoL) changes which were assessed by Pain Disability Index (PDI), 4-item Patient Health Questionnaire (PHQ-4), Pittsburgh Sleep Quality Index (PSQI), 3-item scale assessing Pain Intensity and Interference (PEG). The willingness of the patients to taper their opioid medications by administering the readiness to Taper Visual Analog scale was also included. Three data collection points were assigned for each participant: baseline, week 4, and week 8 with corresponding levels of CBD-rich extract use at each interval. The outcomes’ assessment at each of the three timepoints was conducted via phone or in-person interviews on the web or paper-based questionnaires and/or scales according to the patient’s preference. In addition, open-ended comments were allowed and documented for qualitative analysis.
Patient-reported side effects were collected at each clinic visit and at the time of follow-up questionnaire completion. Side effects were considered serious if they were lifethreatening, resulting in hospitalization or emergency department visits, or required medical intervention for resolution. No serious side effects were reported.
Data analysis
Data analysis was conducted using SPSS v.24 software (SPSS Inc., Chicago, IL). Continuous variables are presented as mean ± SD. Cronbach’s alpha was calculated for each of the included scales to assess the reliability of indices. Normal distribution of the data was checked by the Kolmogorov–Smirnov test. If normally distributed, ANOVA test was used to compare the means of the outcomes between the three levels of CBD-rich extract use. For categorical variables, chi-Square test was used. Otherwise, the corresponding non-parametric tests were used. P value <0.05 was considered statistically significant in all these tests.
Results
The study recruited 131 participants, 97 of whom completed the 8-week follow-up period. All of the 97 participants, 31 males & 66 females, had a documented diagnosis of chronic pain and were on a stable on opioid dose for at least 2 years. The mean age of the study population was 56.1 years (range from 39 to 70 years). Ninety-four (96.9%) out of the 97 participants who completed the 8-week follow-up period used CBD hemp extract.
Primary outcomes
Fifty of the 94 (53.2%) participants using the CBD hemp extract were able to reduce opioid medications at week 8. Additional reductions in polypharmacy on the medication receipt were noted; six participants reported reducing or eliminating their anxiety medications, and four participants reported reducing or eliminating their sleep medication. None of the three participants who declined to use CBD hemp extract reduced their opioid medication at any interval.
Secondary outcomes
Eighty-nine (94%) of the hemp CBD users reported improved quality of life outcomes on subjective, open-ended questions. Quality of life was further evaluated by the four indices and/or questionnaires PDI, PHQ-4, PSQI, and PEG. For each of these indices, the reliability was measured through the Cronbach’s alpha which was relatively high for all of them, indicating good reliability. Cronbach’s alpha was 0.88, 0.77, 0.63, and 0.89 for the PDI, PHQ-4, PSQI, and PEG, respectively
The first index, PDI, was assessed with its seven components and showed no significant changes over the study duration, starting from 38.02 (95% CI 35.38–40.66) at baseline, declining to 36.4 (95% CI 34.15–38.73) and 34.1 (95% CI 31.61–36.58) at weeks 4 and 8, respectively (p = 0.09). In addition, the change in the PHQ-4 for the CBD-rich extract showed no statistically significant difference over the follow-up period (4.8 [95% CI 4.18–5.41] at baseline and 4.5 at week 4 [95% CI 3.95–5.12] and week 8 [95% CI 3.79–5.14], p = 0.7).
Sleep quality was assessed via the PSQI. The mean score value significantly changed from 12.09 (95% CI 11.37–12.80) at baseline to 10.7 (95% CI 9.99–11.44) and 10.3 (95% CI 9.48–11.20) at week 4 and week 8, respectively (p = 0.03). Similarly, the PEG scale showed significant difference among the follow-up points (6.5 [95% CI 6.16–6.81], 5.9 [95% CI 5.55–6.25]and 5.7 [95% CI 5.31–6.12] at baseline, week 4 and week 8, respectively, p = 0.006). Table 1 and Figure 1 show the change in the quality of life indices.
The willingness to reduce the opioid dose was evaluated through the readiness to taper the visual analog scale. The average score was 4.6 (95% CI 4.1–5.3) at baseline, and 4.4 at weeks 4 (95% CI 3.7–5.1) and 8 (95% CI 3.6–5.2) (p = 0.8) with no significant change.
To assess the impact of gender, all parameters were compared between males and females in our study population. No statistically significant differences between both genders were detected for all time points, except for PHQ-4 score which showed a significant decline in males compared with females at week 8 (indicating better effectiveness in males). However, this significant difference was not present at baseline or week 4.
Discussion
The results of this study suggest that using CBD-rich hemp extract oil may help reduce opioid use and improve quality of life, specifically in regards to pain and sleep, among chronic pain patients. This is consistent with emerging literature on the topic, which has concluded that CBD is an effective analgesic, and one that helps reduce barriers to opioid reduction, such as physiological withdrawal symptoms [22–31]. Recently, Wiese et al. summarized the evidence for different used of the cannabinoids with opioids [13]. Haroutounian et al. evaluated the pain in 308 patients using S-TOPS pain score. The score was significantly improved from 83.8 to 75, with 65.9% of patients reported pain improvement. In addition, sleep quality showed significant improvement [28]. Additional studies showed significant improvement in pain symptoms using CBD as augmentation for opioids [9,25–31].
Limitations
At the beginning of the study, the investigator hypothesized that participants may report reduced opioid use in order to appear agreeable to the interviewers, but this concern changed with experience. In reality, many participants disclosed that they were hesitant to report any reduction in opioid use due to the potential consequences of changes in prescriptions. If CBD-rich hemp extract helped their pain and resulted in decreased opioid use, this would result in limited prescription opioids. They often questioned what would happen at the conclusion of the study if the patient could not access affordable CBDrich hemp extract and their pain returned to baseline. Opioids are likely covered by insurance, but CBD-rich hemp extract is not.
Additionally, there is a small amount (<0.3%) of delta9-THC, the intoxicating compound abundant in marijuana plants, in CBD-rich hemp extract. This poses a risk that participants could fail a drug test at work or in other pain management settings, compromising their employment, livelihood, and medical care. They could not risk this consequence. It is important to consider that while the study population did not include participants with dual diagnoses or a history of substance use disorders, but nevertheless several participants described themselves as ‘addicted to’ their opioid pain medications.
According to the World Health Organization, the public health risk of CBD is considered limited, but cannabis use is not absent of abuse risk or addiction potential [32,33]. Cannabis derived from hemp, including the product used in this study, is high in CBD and low in THC and is considered less harmful than the alternative [34]. Still, cannabis use disorder is real and some studies show cannabis may perpetuate the cycle of addiction or lead to other substance abuse [35,36]. Additionally, even with cannabis products with low THC concentration, the aroma of cannabis itself could present the risk of cue-induced drug-seeking behavior in those with previous substance use disorder.
Our study limitations include a lack of a randomized, placebo-controlled design. The short length of the study, lack of control group, and relatively small sample size limit conclusions. The attrition rate was moderate and was influenced by external factors such as changes in or loss of patient insurance plans and alteration in insurance policies at the primary clinic over the course of the study. Several participants’ phone service was canceled over the course of the study which contributed to the attrition rate. As with all voluntary participation studies, the potential differences in those who agreed to participate versus those who declined to participate may influence the study conclusion.
Pain diagnoses, comorbidities, type of opioid, opioid dose and CBD dose also varied among the participants. Several patients used fentanyl patches and therefore could not self-titrate to reduce opioid intake, as was possible with short-acting oral medications, such as oxycodone/acetaminophen and oxycodone controlled release. Variables such as changes in weather may contribute to pain, as the study began in warm months and concluded in colder months, a factor many participants reported as influencing their pain. Several participants noted significant life events that likely influenced pain and medication use, such as a car accident or surgery, during the study period. A final average change in MEQ over time would have been a valuable data point, but it was not available as many prescriptions did not officially change due to short study duration. Two participants reported completely eliminating opioid use over the 8-week period, while others reported deliberately skipping or forgetting doses of opioid medication. Some reported skipping or missing doses every day, whereas others did so irregularly. Still, more detailed data on average MEQ change over time would have improved clarity of study outcomes.
Finally, due to their subjective natures, the variables of pain, sleep, and mood are difficult variables to assess, even with validated instruments. The risk of confirmation and response biases during interviews cannot be ignored.
Future research should expand on these findings and include larger, randomized, placebo-controlled trials. These results also signal a need for improved clinical education on the topic, particularly in the pain management specialty, and potential adjustments to drug-test policies within clinics and across employers.
Conclusion
This study concludes that using CBD for chronic pain in patients using opioids has a significant effect on reducing opioid intake, reducing pain and improving QoL. Over half of the participants who added CBD hemp extract reduced or eliminated opioids over the course of 8 weeks, and almost all CBD users reported improvements in QoL.
Acknowledgments
James Murphy granted access to his patient population for this study and allowed enrollment and data collection in his clinic, Murphy Pain Center. He has agreed to be acknowledged in this study.
Data analysis and editorial assistance were provided by Omar Aboshady a medical writer and freelancer at Upwork.
Data sharing
The data that support the findings of this study are available from the corresponding author, AC, upon reasonable request.
Reviewer disclosure
One of the reviewers is a Consultant/Speaker and Researcher for US World Meds, BDSI, Salix, Enalare, Scilex, and Neumentum. They have no relationship with this specific research.
Funding
The study was funded by Ananda Professional. The funders had no role in study design, data collection, and analysis, or preparation of the manuscript. Alex Capano is employed by Ecofibre Ltd, which wholly owns the sponsor company, Ananda Professional.
Declaration of interest
No potential conflict of interest was reported by the authors.
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CIPN (Chemotherapy-Induced Peripheral Neuropathy)
The purpose of this study is to assess the effect of a hemp-based cannabidiol (CBD) product, Ananda Professional Spectrum Gelcaps, on the severity and duration of chemotherapy-induced neuropathy (CIPN) among non-metastatic breast, colorectal, uterine and ovarian cancer patients who received neoadjuvant or adjuvant therapy that included neurotoxic chemotherapeutic agents.

- Study Focus: CIPN (Chemotherapy-Induced Peripheral Neuropathy)
- Product Studied: Full Spectrum Softgels
- Research Institution: Lankenau Institue for Medical Research
- Patient Population: Breast, Colon, and Ovarian Cancer
- Location: Philadelphia, PA
- Type/Phase: Phase II
- Status: Enrollment Underway (FDA authorized-IND)
Effect of Hemp-CBD on Patients With CIPN
Brief Summary
The purpose of this study is to assess the effect of a hemp-based cannabidiol (CBD) product, Ananda Professional Spectrum Gelcaps, on the severity and duration of chemotherapy-induced neuropathy (CIPN) among non-metastatic breast, colorectal, uterine and ovarian cancer patients who received neoadjuvant or adjuvant therapy that included neurotoxic chemotherapeutic agents.
Detailed Description
CIPN is a common complication of many effective cytotoxic agents that can negatively impact patients’ treatment course and quality of life. The incidence of CIPN in cancer patients receiving multidrug regimens is estimated at 38%, with frequencies approaching 100% with certain known neurotoxic drug classes. Taxanes (e.g., paclitaxel, docetaxel) and platinum-based agents (e.g., oxaliplatin, cisplatin, carboplatin) in particular, are two commonly used chemotherapy classes that are associated with a high incidence of CIPN. Symptoms of chemotherapy-induced peripheral neuropathy include distal extremity numbness, tingling and pain. Chronic, cumulative symptoms can severely impact quality of life and result in dose reductions and/or drug discontinuation in up to 30% of patients. Consumers use cannabis products for various reasons including pain, stress, anxiety, and insomnia. The neuro-modulatory effects of phytocannabinoids, tetrahydrocannabinol (THC) and cannabidiol (CBD) in particular, have been documented at both the molecular and clinical level. The endocannabinoid system consists of CB1 receptors and CB2 receptors that act as an inhibitory G-protein within the central and peripheral nervous system, respectively. Several animal models have demonstrated the role endocannabinoids play in neuropathic pain development by showing enhanced neuropathic pain with CB1 receptor deletion and reduced manifestations of neuropathic pain with CB2 receptor overexpression. The therapeutic properties of cannabis-based products have also been illustrated in several randomized double-blind trials that have shown significant pain relief versus placebo in the treatment of neuropathy related to diabetes, spinal cord injury, multiple sclerosis, and HIV associated polyneuropathy. Studies specifically looking at the role of CBD in chemotherapy-induced neurotoxicity have shown a neuroprotective effect of CBD in mouse models. Studies have demonstrated that a 14-day dosing regimen of CBD prevented the onset of paclitaxel-induced mechanical and thermal sensitivity. These intriguing results suggest that cannabinoid agents could potentially reduce the severity and duration of CIPN in the clinical setting.
Criteria
Inclusion Criteria: – Non-metastatic breast cancer patients who developed CIPN (CTCAE sensory grade 2 or 3, motor grade <2) after receiving taxane-based chemotherapy in pre-operative or post-operative setting. – Non-metastatic Colorectal cancer patients with high risk stage II and stage III disease who developed CIPN (CTCAE sensory grade 2 or 3, motor grade <2) after receiving oxaliplatin in the adjuvant setting. – Ovarian cancer patients who developed CIPN (CTCAE sensory grade 2 or 3, motor grade <2) after receiving taxane-containing chemotherapy in the neoadjuvant or adjuvant setting . – Uterine cancer patients who developed CIPN (CTCAE grade 2 or 3) after receiving taxane-containing chemotherapy in the neoadjuvant or adjuvant setting. Exclusion Criteria: – Family history of genetic/familial neuropathy – Routine use of recreational or medicinal marijuana products (defined as > 4 times per month) or illicit drug use (positive urine drug screen including opioids, cocaine, amphetamines, PCP, LSD) – Known underlying liver disease (Child-Pugh B or C) or baseline elevation in ALT, AST or total bilirubin ≥1.5 x upper limit of normal – Patients taking certain medications will be excluded due to potential CBD-drug interaction. CBD may prevent appropriate drug metabolism increasing risk for toxicity. Co-administration of study product and the following medications will be contraindicated and may lead to participant exclusion: clarithromycin, itraconazole, erythromycin, fluconazole, clopidogrel, rifampin, sulfamethoxazole, warfarin, any opioids, warfarin, antiepileptic medications (including carbamazapine, phenytoin, valproic acid, but excepting of gabapentin, clonazepam or diazepam). – Underlying history of epilepsy/ recurrent seizure disorder or unexplained seizure within past 6 months – Patients with uncontrolled cardiovascular disease defined by myocardial infarction, stroke or transient ischemic attack, or need for coronary stent placement within past six months. – Patients with uncontrolled psychiatric illness (who meet DSM-V criteria) or who are at increased risk for suicidality based on baseline Columbia-Suicide Severity Rating Scale. – Women who are pregnant or breastfeeding or who refuse to practice an effective form of birth control (condoms, diaphragm, birth control pill, IUD)
Sleep and Anxiety
This is a randomized, double-blinded, placebo-controlled, crossover trial that aims to determine the efficacy of THC-free CBD oil in reducing the severity of agitation among participants, and determine whether THC-free CBD oil can reduce the burden on caregivers and increase the participants’ quality of life.

- Study Focus: Sleep and Anxiety
- Product Studied: Broad Spectrum Softgels
- Research Institution: Eastern Virginia Medical School
- Patient Population: Dementia
- Location: Norfolk, VA
- Type/Phase: Phase II
- Status: Enrollment Underway (FDA authorized-IND)
Effects of THC-Free CBD Oil on Agitation in Patients With Alzheimer’s Disease
Brief Summary
This is a randomized, double-blinded, placebo-controlled, crossover trial that aims to 1) determine the efficacy of THC-free cannabidiol (CBD oil) in reducing the severity of agitation among participants and 2) determine whether THC-free CBD oil can reduce the burden on caregivers and increase the participants’ quality of life.
Detailed Description
Individuals with Alzheimer’s and other forms of dementia often go through a period of significant behavioral and psychological symptoms of dementia (BPSD). It is estimated that up to 90% of persons with dementia (PWD) experience behavior problems at some point. BPSDs can be challenging for both unpaid family caregivers as well as paid caregivers. Family caregivers provide the bulk of care for PWD and number over 15 million. One of the most common types of BPSDs is agitation with a prevalence of up to 87%, based on a recent systematic review. Agitation can lead to impaired daily functioning, prolongation of hospitalization, reduced time to institutionalization, and is associated with higher mortality. Additionally, agitated behavior is associated with increased injury to both patients and caregivers. Based on the 2018 Alzheimer’s disease drug development pipeline report almost 70% of clinical trials related to BPSD are dedicated to agitation behavior. Finding ways to address agitation is necessary to improve overall quality of life for PWD and their caregivers. Currently, there are no medications available specifically for the treatment of BPSDs. The use of benzodiazepines, antipsychotics and mood stabilizing agents are common, but the risks and side effects often outweigh any benefits.
Several small studies have investigated the use of cannabinoids in the treatment of pathology and symptomology of Alzheimer’s disease (AD), as well as treatment of the agitation component of BPSD. A handful of these studies showed that the symptoms of BPSD were decreased with the use of cannabinoids. However, due to small sample sizes, study design, and short trial duration of these studies, the efficacy of these agents on BPSD cannot be confirmed. In addition, cannabinoids have demonstrated anti-oxidant and anti-inflammatory effects, and both processes have been indicated as major contributors to the neurologic effects of AD. Some evidence exists that agitation is related to this neuroinflammatory process. This study will examine the effects of cannabinoids on the behavioral and psychological symptoms of individuals with a dementia diagnosis.
Outcome Measures
Primary Outcome Measures
1. Change in agitation and aggression. [ Time Frame: Every two weeks for 15 weeks during study enrollment. ] Change in agitation and aggression will be measured by the Cohen-Mansfield Agitation Inventory (CMAI), a validated 29-item questionnaire to assess agitation. Each item is rated on a 7-point scale ranging from 1 “Never” to 7 “Several times per hour”. Higher scores indicate greater agitation.
2. Change in caregiver burden. [ Time Frame: Three times during the 15 weeks of study enrollment. ] Change in caregiver burden will be measured by the Zarit Burden Interview (ZBI), a validated 22-item questionnaire to assess caregiver burden. Each item is rated on a 5-point Likert scale that ranges from 0 “Never” to 4 “Nearly always,” with the sum of scores ranging between 0-88. Higher scores indicate greater burden.
3. Change in the participant’s quality of life. [ Time Frame: Three times during the 15 weeks of study enrollment. ] Change in the participant’s quality of life will be measured by the Quality-of-life assessment in dementia (DEMQOL-proxy), a validated 32-item questionnaire to assess the health related quality of life of people with dementia. Each item is rated on a 4-point scale ranging from 1 “A lot” to 4 “Not at all”. Higher scores indicate a healthier quality of life.
4. Change in caregiver’s quality of life. [ Time Frame: Three times during the 15 weeks of study enrollment. ]Change in the caregiver’s quality of life will be measured by the Measurement of quality of life in family carers of people with dementia (C-DEMQOL), a validated 30-item questionnaire to assess the quality of life for carers of someone with dementia. Each item is rated on a 5-point scale ranging from 1 “Completely” to 5 “Not at all.” Higher scores indicate a healthier quality of life.
Secondary Outcome Measures
1. Assessment of change in neuropsychiatric symptoms. [ Time Frame: Three times during the 15 weeks of study enrollment. ] Assessment of change in neuropsychiatric symptoms for the participant will be measured by the Neuropsychiatric Inventory (NPI), a validated questionnaire that assesses dementia-related behavioral symptoms. The NPI examines 12 sub-domains of behavioral functioning. Each sub-domain is rated on the frequency of the symptoms using a 4-point scale with 1 “Occasionally” and 4 “Very frequently”, the severity of the symptoms using a 3-point scale with 1 “Mild” and 3 “Marked”, and the distress the symptom causes them on a 5-point scale with 1 “Not at all” and 5 “Very severely or extremely”.
2. Assessment of change in cognitive skills. [ Time Frame: Three times during the 15 weeks of study enrollment. ]Assessment of change in cognitive skills for the participant will be measured by the Mini Mental State Exam (MMSE), a validated 30-item questionnaire used to measure cognitive impairment among the elderly. A 30-item, clinician-administered assessment of orientation, attention, calculation, learning and memory, language, and visuospatial skills. Each correct response is summed to produce a total score out of 30 possible points.
3. The effect of CBD oil on sleep quantity measured by Fitbit [ Time Frame: Measured on a daily basis during the 15 weeks of study enrollment. ] The effect of CBD oil on sleep quality will be measured for the participant and caregiver using the actigraphy function of fit bit. These measures include the amount of total sleep, amount of rapid eye movement (REM) sleep and the amount of deep and light sleep.
Eligibility Criteria
Inclusion Criteria
Males/females over 50 years old.
Have a diagnosis of dementia due to AD or mixed AD with another type of dementia.
A Mini-Mental State Exam score (MMSE) between 4 and 28 inclusive.
Presence of agitation with a Neuropsychiatric Inventory (NPI)-agitation/aggression subscore > 3.
Participants and their informal caregivers must be fluent in English (includes reading, writing, and speech) and able to give informed consent.
For patients treated with cognitive-enhancing medications (cholinesterase inhibitors (ChEI) and/or memantine), the dosage must be stable for at least 1 month (30 days). If the ChEI and/or memantine has been discontinued, patients may enroll after 15 days.
Eligible caregivers must either live with the participant or have a minimum of 4 hours of daily contact with them.
Exclusion Criteria
Diagnosis of non-AD or non-mixed dementias.
Very mild dementia or advanced dementia (MMSE: greater than 28 or less than 4).
NPI-agitation-aggression score < 3.
Having a serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease which might confound assessment of safety outcomes as determined by the study physician.
Presence or history of other serious psychiatric disorders or neurological conditions (e.g. psychotic disorders, bipolar disorder or schizophrenia).
Current abuse of/dependence on marijuana, current drug abuse, current alcohol abuse.
Having seizure disorders.
Pregnant or breastfeeding
Indication of baseline delirium as determined by the Confusion Assessment Method (CAM).
Current use of lithium.
Inability to swallow CBD oil softgels.
Changes in dosage of anti-depressives within 4 weeks before randomization and during the study.
Changes in dosage of antipsychotics or benzodiazepines within 1 week prior to randomization and during the study.
Contraindications to CBD oil (history of hypersensitivity to any cannabinoid).
Frequent falling due to orthostatic hypotension.
Use of tricyclic antidepressants (TCA), fluoxetine, and/or carbamazepine. -Patients who reside in nursing homes.
Sleep
This trial involves participation in a randomized placebo-controlled clinical trial. The study also involves a placebo, which has no therapeutic value, but is similar in look, taste and smell to the other treatment being tested. The product that is being tested is a medicinal cannabis product, specifically cannabidiol or CBD. Recent research has identified that CBD can have benefits in improving sleep disturbance symptoms and mood.

- Study Focus: Sleep
- Product Studied: Broad Spectrum Softgels
- Research Institution: Southern Cross University
- Patient Population: Healthy Population
- Location: Australia (4 sites)
- Type/Phase: Phase II-B
- Status: Enrollment Underway
Human Research Ethics Approval for Phase IIb clinical trial in Australia
Brief Summary
– Ecofibre is undertaking a Phase IIb double-blind, randomised placebo-controlled, multi-site clinical trial for CBD for sleep disturbances in a healthy population
– The study has received Human Research Ethics Committee (HREC) approval and will look to begin patient enrolment in Q4FY21
– The purpose of this study is to support Ecofibre’s TGA application to supply Ananda Hemp products via the Australian S3 OTC pharmacy market. The investment in this research is ~$1.2m.
– The findings of this study will also support Ananda Hemp’s existing full and broad sprectum (THC free) products available via the Special Access Scheme (SAS-B) and Authorised Prescriber pathways
– This study is part of Ecofibre’s broader research portfolio on hemp-derived products across a range of disease states
Ecofibre Limited (Ecofibre, Company) (ASX:EOF, US ADR: EOFBY) is pleased to announce that it has received Human Research Ethics Approval for its major Australia-based clinical trial in support of its TGA S3 application.
Dr. Janet Schloss of Southern Cross University (SCU) has been appointed as chief investigator for the study, which is titled “Phase IIb Double-Blind, Placebo-Controlled Randomised Clinical Trial for CBD for sleep disturbances in a healthy population” (the “Ananda CBD Sleep Study”).
Ecofibre Chairman Barry Lambert said, “today’s announcement of the Ananda CBD Sleep Study is a major step forward for Australians to eventually access hemp-derived CBD products ‘over the counter’ at their local pharmacy”.
Ecofibre CEO, Eric Wang said, “The study protocol has been rigorously designed and will be appropriately powered to deliver sufficient data for statistical significance. The trial will be conducted at four separate sites across Australia with several hundred participants. The team have taken significant care in designing the study to ensure it meets the high standards of the TGA for S3 medicine registration”.
“We are using the Ananda Hemp Broad Spectrum (THC-free) soft gels. This product has been available in the US since 2018 under the Ananda Professional brand which is the #1 US Independent Pharmacy brand. The product is available in all 50 States”.
“This product is also being used in our FDA authorised clinical trial on agitation in patients with Alzheimer’s disease. This phase II clinical trial is being conducted at Eastern Virginia Medical School with Dr. Henry Okravi as the principal investigator. This study is enrolling patients and expects to be completed by early 2022″.
Australian S3 Market
The regulatory framework for the S3 market was established following an announcement by the TGA on 15 December 20201 to down-schedule certain low dose cannabidiol (CBD) preparations from Schedule 4 (Prescription Only Medicine) to Schedule 3 (Pharmacist Only Medicine) from 1 February 2021.
There are currently no TGA approved products on the Australian Register of Therapeutic Goods (ARTG) that meet the Schedule 3 criteria.
Eric Wang said, “we are very pleased with the TGA’s decision to allow for the down-scheduling of lowdose CBD products. While estimates on the size of Australian OTC CBD market vary, based on our significant experience with CBD in the US OTC pharmacy market, we see a strong opportunity to help many Australians live a better life”.
“As the leading US pharmacy CBD brand, we understand there are many foundational elements that go beyond the product itself that need to be put in place to support pharmacists in dispensing and educating patients on CBD. We have begun the process of delivering our platforms to Australia and are working with specific national pharmacy groups and education bodies at this time”.
Ecofibre currently sells two of its existing US manufactured Ananda Hemp (CBD dominant) products in Australia via the Special Access Scheme (SAS-B) and Authorised Prescribers. Both of these products are widely available in the US and have been sold in all 50 US States for several years.
Update on Ecofibre clinical research program
A component of the overall platform to support pharmacists in recommending CBD products is clinical research. Ecofibre continues to invest appropriately in this area to ensure we can provide our customers with the support required for our product set. The following table provides a short update on our research program.

Addiction
This is a double-blind, placebo-controlled, parallel group study designed to assess the efficacy of full spectrum CBD and broad spectrum CBD, compared to a placebo control (PC), to reduce drinking in participants with moderate alcohol use disorder according to the DSM-V. If eligible for the study, subjects will be randomized to receive one of the conditions for 8 weeks.

- Study Focus: Addiction
- Product Studied: Full Spectrum Softgels
- Research Institution: University of Colorado
- Patient Population: Alcohol Use Disorder
- Location: Boulder, CO
- Type/Phase: Phase II
- Status: Enrollment Underway (FDA authorized-IND)
CBD for the Treatment of Alcohol Use Disorder
Brief Summary
This is a double-blind, placebo-controlled, parallel group study designed to assess the efficacy of full spectrum CBD and broad spectrum CBD, compared to a placebo control (PC), to reduce drinking in participants with moderate alcohol use disorder according to the DSM-V. If eligible for the study, subjects will be randomized to receive one of the conditions for 8 weeks.
Detailed Description:
The current study will directly test the hypothesis that a moderate dose of CBD leads to a reduction in alcohol consumption, alcohol craving, peripheral markers of inflammation, and anxiety. It is further hypothesized that CBD will lead to increased sleep duration and quality among individuals with AUD who want to quit or reduce their drinking. The study will also determine whether the small amount of THC found in full spectrum hemp-derived CBD products produces any negative effects. The hypotheses are grounded in previous studies suggesting that CBD reduces the reinforcing properties of alcohol and decreases drinking motivation and consumption (Viudez-Martínez, García-Gutiérrez, Fraguas-Sánchez, et al., 2018). Further, CBD has shown clinical promise for tobacco, cannabis, and opioid use disorders (Hurd, 2017; Hurd et al., 2015; Prud’homme et al., 2015), and evidence indicates that these effects may be due to the ability of CBD to reduce cue-induced craving and anxiety (Gonzalez-Cuevas et al., 2018; Hurd et al., 2019). The hypotheses are also grounded in the pre-clinical literature suggesting that CBD may modulate the immune system and have anti-inflammatory effects which also helps to reduce harm associated with alcohol and may have a positive effect on those attempting to quit. Other potential mechanisms that might underlie the effects of CBD include a reduction in the severity of acute withdrawal, a reduction in protracted withdrawal, and the neuroprotective effects of CBD. Given the background literature with respect to CBD and AUDs, a logical next step is for human studies to address these questions.
To better understand the effects of hemp-derived CBD with and without a small amount of THC, the investigators propose a Phase II randomized clinical trial (RCT) to examine the safety, tolerability, and clinical effects of Full Spectrum CBD (fsCBD, contains less than 0.3% THC) vs. Broad Spectrum CBD (bsCBD, does not contain THC), vs. a matching placebo in a population of AUD subjects.
This is a double-blind, placebo-controlled, parallel group study designed to assess the efficacy of fsCBD and bsCBD, compared to a placebo control (PC), to reduce drinking in participants with moderate alcohol use disorder according to the DSM-V. If eligible for the study, subjects will be randomized to receive one of the conditions for 8 weeks.
To minimize risk of COVID transmission, the investigators will utilize Zoom for weekly subject check-ins and our Mobile Pharmacology Lab (MPL) for the collection of blood samples and clinical data for the majority of in-person visits. The initial Week 0 / Baseline visit will take place at the University of Colorado Anschutz Medical Campus. There will be MPL follow-up visits at Weeks 1, 4, and 8. Participants will be contacted by Zoom each remaining week during the 8-week period. A follow up Zoom interview will occur in Week 16 approximately 8 weeks after the end of dosing.
Overall, the clinical study is expected to take 1-2 years to complete enrollment and data analysis
Arms and Interventions
Arms
Active Comparator: Full-spectrum Cannabidiol
150mg/day of full-spectrum cannabidiol, containing less than 0.3%THC.
Experimental: Broad-spectrum Cannabidiol
150mg/day of broad-spectrum cannabidiol, containing 0%THC.
Placebo Comparator: Placebo
150mg/day of hemp-seed oil with no cannabinoids present.
Intervention/treatment
Drug: Cannabidiol
The current study will directly test the hypothesis that a moderate dose of CBD leads to a reduction in alcohol consumption, alcohol craving, peripheral markers of inflammation, and anxiety. Other Name: CBD
Drug: Cannabidiol
The current study will directly test the hypothesis that a moderate dose of CBD leads to a reduction in alcohol consumption, alcohol craving, peripheral markers of inflammation, and anxiety. Other Name: CBD
Drug: Placebo
Placebo arm
Outcome Measures
Primary Outcome Measure
1. Drinks per Drinking Day [ Time Frame: 0-8 weeks ]. The Time Line Follow Back is a calendar-assisted measure that can be used to assess alcohol, tobacco, cannabis, and other substance use. The investigators will use this measure to create the Drinks per Drinking Day variable.
2. Drinks per Drinking Day [ Time Frame: 0-16 weeks ]. The Time Line Follow Back is a calendar-assisted measure that can be used to assess alcohol, tobacco, cannabis, and other substance use. The investigators will use this measure to create the Drinks per Drinking Day variable.
3.Drinks per Drinking Day [ Time Frame: 0-4 weeks ]. The Time Line Follow Back is a calendar-assisted measure that can be used to assess alcohol, tobacco, cannabis, and other substance use. The investigators will use this measure to create the Drinks per Drinking Day variable.
4. Drinks per Drinking Day [ Time Frame: 4-8 weeks ]. The Time Line Follow Back is a calendar-assisted measure that can be used to assess alcohol, tobacco, cannabis, and other substance use. The investigators will use this measure to create the Drinks per Drinking Day variable.
5. Alcohol Dependence/Craving [ Time Frame: 0-16 weeks ]. The Alcohol Dependence Scale measures the severity of alcohol dependence and craving symptoms. Possible scores range from 0 to 47 with higher scores indicating a worse outcome/more severe symptoms of alcohol dependency/craving.
6. Alcohol Dependence/Craving [ Time Frame: 0-8 weeks ]. The Alcohol Dependence Scale measures the severity of alcohol dependence and craving symptoms. Possible scores range from 0 to 47 with higher scores indicating a worse outcome/more severe symptoms of alcohol dependency/craving.
7. Alcohol Dependence/Craving [ Time Frame: 0-4 weeks ]. The Alcohol Dependence Scale measures the severity of alcohol dependence and craving symptoms. Possible scores range from 0 to 47 with higher scores indicating a worse outcome/more severe symptoms of alcohol dependency/craving.
Alcohol Dependence/Craving [ Time Frame: 4-8 weeks ]. The Alcohol Dependence Scale measures the severity of alcohol dependence and craving symptoms. Possible scores range from 0 to 47 with higher scores indicating a worse outcome/more severe symptoms of alcohol dependency/craving.
Secondary Outcome Measures
1. Cue-reactivity [ Time Frame: 0-4 weeks ]. Cue-elicited urge to drink will be assessed using the cue-reactivity assessment, per protocol (Hutchison, 2006).
2. Cue-reactivity [ Time Frame: 4-8 weeks ]. Cue-elicited urge to drink will be assessed using the cue-reactivity assessment, per protocol (Hutchison, 2006).
3. Cue-reactivity [ Time Frame: 0-8 weeks ]. Cue-elicited urge to drink will be assessed using the cue-reactivity assessment, per protocol (Hutchison, 2006) .
4. Anxiety [ Time Frame: 0-4 weeks ]. The Beck Anxiety Inventory measures the severity of anxiety symptoms. Possible scores range from 0 to 63 with higher scores indicating a worse outcome/more severe symptoms of anxiety.
5. Anxiety [ Time Frame: 4-8 weeks ]. The Beck Anxiety Inventory measures the severity of anxiety symptoms. Possible scores range from 0 to 63 with higher scores indicating a worse outcome/more severe symptoms of anxiety.
6. Anxiety [ Time Frame: 0-8 weeks ]. The Beck Anxiety Inventory measures the severity of anxiety symptoms. Possible scores range from 0 to 63 with higher scores indicating a worse outcome/more severe symptoms of anxiety.
7. Anxiety [ Time Frame: 0-16 weeks ]. The Beck Anxiety Inventory measures the severity of anxiety symptoms. Possible scores range from 0 to 63 with higher scores indicating a worse outcome/more severe symptoms of anxiety.
8. Subjective Pain Level [ Time Frame: 0-4 weeks ] The McGill Pain Questionnaire measures the severity of subjective pain. Possible scores range from 0 to 78 with higher scores indicating a worse outcome/more severe symptoms of subjective pain.
9. Subjective Pain Level [ Time Frame: 4-8 weeks ]. The McGill Pain Questionnaire measures the severity of subjective pain. Possible scores range from 0 to 78 with higher scores indicating a worse outcome/more severe symptoms of subjective pain.
10. Subjective Pain Level [ Time Frame: 0-8 weeks ]. The McGill Pain Questionnaire measures the severity of subjective pain. Possible scores range from 0 to 78 with higher scores indicating a worse outcome/more severe symptoms of subjective pain.
11. Subjective Pain Level [ Time Frame: 0-16 weeks ]. The McGill Pain Questionnaire measures the severity of subjective pain. Possible scores range from 0 to 78 with higher scores indicating a worse outcome/more severe symptoms of subjective pain.
12. Sleep Quality [ Time Frame: 0-16 weeks ]. The Pittsburgh Sleep Quality Index measures the severity of sleep disturbances. Possible scores range from 0 to 21 with higher scores indicating a worse outcome/more severe symptoms of sleep disturbance.
13. Sleep Quality [ Time Frame: 0-8 weeks ].The Pittsburgh Sleep Quality Index measures the severity of sleep disturbances. Possible scores range from 0 to 21 with higher scores indicating a worse outcome/more severe symptoms of sleep disturbance.
14. Sleep Quality [ Time Frame: 4-8 weeks ]. The Pittsburgh Sleep Quality Index measures the severity of sleep disturbances. Possible scores range from 0 to 21 with higher scores indicating a worse outcome/more severe symptoms of sleep disturbance.
15. Sleep Quality [ Time Frame: 0-4 weeks ]. The Pittsburgh Sleep Quality Index measures the severity of sleep disturbances. Possible scores range from 0 to 21 with higher scores indicating a worse outcome/more severe symptoms of sleep disturbance.
Eligibility Criteria
Inclusion Criteria:
1. Must be between 21-60 years old.
2. Meets Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria for current Alcohol Use Disorder (AUD) of at least moderate severity (i.e., 4 or more DSM-V symptoms)
3. Currently seeking treatment for AUD.
4. If male, reports drinking, on average, at least 21 standard alcoholic drinks per week prior to screening; if female, reports drinking, on average, at least 14 standard drinks per week prior to screening.
5. Have at least one heavy drinking day (4 or more drinks per day for women/5 or more drinks per day for men) during the 7-day period prior to screening.
6. Live within 35 miles of the study site.
Exclusion Criteria:
1. Self-reported DSM-V diagnosis of any other substance use disorder.
2. Use nicotine daily.
3. Self-report use of cocaine, amphetamines, opioids, cannabis, or benzodiazepines in the last 30 days.
4. Report having or being treated for a current DSM-V Axis I diagnosis, including major depression, panic disorder, obsessive/compulsive disorder, post-traumatic stress disorder, bipolar affective disorder, schizophrenia, dissociative disorders, eating disorders, or any other psychotic or organic mental disorder.
5. Endorsing an item on the RMTS-S measure of suicide risk.
6. Currently taking any of the following medications: Those known to have a major interaction with Epidiolex. Acute treatment with any antiepileptic medications. Medication known to affect alcohol intake (e.g., disulfiram, naltrexone, acamprosate, and/or topiramate).
7. Self-reported history of severe alcohol withdrawal (e.g., seizure, delirium tremens).
8. Clinically significant medical problems such as cardiovascular, renal, gastrointestinal, or endocrine problems that would impair participation or limit medication ingestion.
9. Current or past alcohol-related medical illness, such as gastrointestinal bleeding, pancreatitis, hepatocellular disease, or peptic ulcer.
10. Females of childbearing potential who are pregnant, nursing, or who are not using a reliable form of birth control.
11. Current charges pending for a violent crime (not including DUI-related offenses).
12. Lack of a stable living situation.
FREE HER (Pelvic Pain)
FREE HER stands for Finding Relief from Endometriosis and Exclusion: Hemp Extract Research. The present study aims to fill the existing gaps in the literature by providing an a priori test of the interest, use patterns, and impact of CBD and cannabis use on pelvic pain, absenteeism, physical and psychosocial symptoms and functioning, and medication use. This is a naturalistic observational study where participants are assessed monthly over the course of one menstrual cycle (approximately 1 month).

- Study Focus: Pain (endometriosis)
- Product Studied: Endo Relief Cream
- Research Institution: Ecofibre
- Patient Population: Endometriosis
- Location: Georgetown, KY
- Type/Phase: Phase IV
- Status: Scheduled Completion 3Q22
Evaluating the effects of hemp extract on female pelvic pain and quality of life indicators: A prospective observational cohort study
Background and Significance:
Various forms of pelvic pain, including dysmenorrhea and endometriosis, affect over 80% of women (Subasinghe et al., 2016). Global studies report to over 30% of women experience pelvic pain severe enough to miss school or work, and up to 80% of women report loss of productivity due to associated symptoms (Grandi et al., 2012; Schoep et al., 2019; Randhawa et al., 2021). The disruption is not limited to days of menstruation, as chronic pelvic pain prevalence, characterized as three to six months in duration, affects 24% of women, (Zondervan et al., 2001). The negative consequences of pelvic pain are significant and include absenteeism’s socioeconomic impacts, lower quality of life, and increased reports of anxiety, sleep disturbances, and other mood disorders, (Armour et al., 2019; Dydyk & Gupta, 2020). Analgesic use is reported by 80-93% of women with pelvic pain, with varying frequency. Combined, 47% report using pain medication “always” or “often”, (Durand et al., 2021). Studies report abusive or inappropriate use of both NSAIDs and narcotic pain medications, such as opioids, further increasing health risks of pelvic pain, (De Sanctis et al., 2015; Argawal et al., 2021).
Recent data demonstrates increased interest in complementary therapies for pelvic pain, with half of sufferers utilizing over the counter herbs or supplements, (Armour et al., 2019; Steel et al., 2018). These supplements include cannabinoids, which have been demonstrated as effective and well tolerated across multiple studies, (Armour 2019; Webster et al., 2020). Cannabinoids, such as cannabidiol (“CBD”), can be derived from federally legal hemp plants in the United States. CBD is a non-intoxicating cannabinoid and not associated withs public health risks, as abuse or dependency risk is virtually absent (WHO, 2018). Because of this favorable safety profile, CBD is currently under investigation for a myriad of symptoms or diseases due to the multiple targets of the endocannabinoid system (ECS).
The Endocannabinoid System:
The ECS is a network of receptors present throughout the central and peripheral nervous systems as well as on many organs and organ systems. Two main receptor types, CB1 and CB2, comprise the ECS. CB1 receptors are ubiquitous in nervous tissue and are the most abundant G-protein coupled receptors in the brain, particularly in the hippocampus, the amygdala, and the prefrontal cortex. CB2 receptors, also GCPRs, are present in the brain, but are more localized throughout the periphery and particularly on immune and lymphatic cells. Through CB1 and CB2 receptors, the ECS influences homeostatic function via multiple mechanisms of action, impacting immune responses, inflammation, appetite, metabolism, pain perception, muscle relaxation, mood, motor control & coordination and more. CB1 and CB2 receptor activity is modulated by anandamide and 2-arachidoniclycerol (2-AG), two confirmed endogenous ligands, as well as exogenous cannabinoids, such as CBD and THC.
The potential role of CBD:
Endocannabinoid receptors are abundant in female reproductive organs, and the central nervous system. Their signaling and trafficking influence multiple physiological and pathophysiological functions of female reproduction, including folliculogenesis, endometrial cell motility, endometrial migration & proliferation, and peripheral innervation associated with endometrial pain (Tanaka et al., 2020). Cannabinoid agonists exert antiproliferative effects on deep infiltrating endometriosis, and increased cannabinoid signaling may reduce proliferation of endometriotic lesions (Leconte et al., 2010; Dmitrieva et al., 2010). Cannabinoid receptors in the pelvis, ovaries, endometrium, vulva and the central and peripheral nervous systems influence inflammation, nociception, and arousal at these therapeutic targets (Bouaziz et al., 2017). Cannabinoids trigger localized vasodilation and relaxation of pathological smooth muscle contraction and/or spasticity (DiBlasio et al., 2013).
Study Aim:
The present study aims to fill the existing gaps in the literature by providing an a priori test of the interest, use patterns, and impact of CBD and cannabis use on pelvic pain, absenteeism, physical and psychosocial symptoms and functioning, and medication use.
Anticipated Impact:
Findings from the proposed project will help advance our knowledge regarding the impact of CBD use (both frequency of use and cannabinoid content) on pain, absenteeism, physical and psychosocial symptoms and functioning and medication use.
Study Design and Approach:
This is a naturalistic observational study where participants are assessed monthly over the course of one menstrual cycle (approximately 1 month).
Methods:
Please see the figure below for a visual outline of study process. Following IRB approval, eligible participants will be identified via collaboration with a network of healthcare providers and directed to the study investigators and electronic consent form. Individuals interested in participating will complete the informed consent electronically via smartphone or computer, followed by a series of self-report questionnaires administered via a secure online system (HIPAA compliant software developed by SurveyMonkey). Survey completion will take approximately 15 minutes on the first day of data collection. Participants will be compensated in the form of one bottle of CBD cream (MSRP $60) for their time. Individuals will then be prompted to complete follow-up assessments, which will take approximately 2-5minutes, daily over their next menstrual cycle. Upon completion of the study, participants will be provided with a $30 Visa gift card
Population and Sample:
In this study, we will focus on a sample of 300 adult (18 years to 65 years of age, female sex) with complaints of pelvic pain, including dysmenorrhea, endometriosis, dyspareunia, and vulvodynia.
Inclusion and Exclusion Criteria:
Inclusion criteria:
– Female sex
– Minimum age 18 years old
– Current complaints of pelvic pain, including any of the following: dysmenorrhea (painful periods), endometriosis or adenomyosis, vulvodynia (vaginal pain), or dyspareunia (pain with sexual activity).
– Ability to provide informed consent
– Ability to read and write in English
– Access to a mobile phone and text messaging
Exclusion criteria:
– Currently pregnant or breastfeeding
– Pregnancy in previous 90 days
– Current diagnosis of urinary tract infection, pelvic inflammatory disease, or acute gynecological infections including bacterial vaginosis and candida vulvovaginitis.
– Initiation and/or discontinuation of hormonal contraception, cooper intrauterine device, GnRh analogues, hormone replacement therapy, or pain medication in previous 90 days
– Initiation, discontinuation, or change in dose of antidepressant, antipsychotic, or anxiolytic medications in previous 90 days
– Currently trying to conceive
– Concurrent use of carbamazepine or anti-seizure medications, lithium, or warfarin
– Serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
– History of hypersensitivity or allergy to cannabinoids, shea butter, or hemp seed oil
– Recent gynecological or abdominal surgery
Study Procedures:
Data collection will be done via electronic surveys with SurveyMonkey’s HIPAA compliant software. Participants will receive a daily text message prompting them to complete the study surveys. No names, dates of birth, or other identifiers will be collected. Ages and relevant complaints regarding pelvic pain will be collected on day one. Initial surveys (day 1) will include the WaLIDD scale, the Menstrual Distress Questionnaire (Form C), and the medical and supplement treatment receipt. This will take approximately 15-20 minutes. The remaining days (i.e. days 2-29) will include only the Menstrual Distress Questionnaire (Form T) and the Medical and supplement treatment receipt. This will take approximately 5 minutes per day. The final day (i.e. day 30) will include the Menstrual Distress Questionnaire (Form T), the Medical and supplement treatment receipt, and the WaLIDD scale, which will take approximately 7 minutes.
Data will take the form of self-report questionnaires, including:
1. WaLIDD scale
2. Menstrual Distress Questionnaire (Form C)
3. Menstrual Distress Questionnaire (Form T)
4. Medical & supplement treatment receipt
The medical and supplement treatment receipt assumes collection of data regarding whether and how the participants use any hemp, CBD, or cannabis product.
Privacy and Confidentiality:
The participants will not share their name, date of birth, or other identifying information with the Study Investigators at any point, as this data will not be collected. The data will be collected via HIPAA compliant survey software, SurveyMonkey Enterprise, a secure data collection and storage system that is able to make responses anonymous, and is encrypted by SSL. Data sets will only be accessed by the Study Investigator via encrypted networks and stored in an encrypted file that is password protected. Any potentially identifying information, such as phone number, will be stored separately from the data set in a secured, encrypted, password protected file.
Analysis Plan:
Demographic data will be used to describe the sample for the purpose of determining generalizability of results. Prior to data analysis, data will be examined for normality and outliers. In addition, we will examine correlations among variables of interest. To investigate the role of CBD use on the trajectory of pain, absenteeism, physical and psychological symptoms and functioning, and medication & supplement use across the 1-month assessment period, generalized linear mixed modeling (GLMM) will be employed using the R statistical package. Independent models will be conducted for each outcome of interest. The trajectory will be comprised of the 3 (baseline + 2 monthly assessments) assessment time-points. Two levels will be modeled using GLMM procedures. Level 1 will represent the empty model, in which change in pain, absenteeism, physical and psychosocial symptoms and functioning, and supplement & medication use, will be modeled as a function of time (i.e., over the course of the 1-month assessment period). Level 2 will include the full model in which time varying covariates (i.e., CBD product use frequency and cannabinoid concentration) will be included.
References
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Gynecological Disorder
The groundbreaking results from this clinical study using patient-derived organoids have led to four patent filings. Women with metastatic gynecological cancers have limited treatment options. The 5-year survival rate of many gynecological cancers is lower than other solid cancers and has not significantly improved in the last 20 years. We are excited about these initial results and now developing strong scientific rationale for the clinical application of CBD for various gynecological disorders.

- Study Focus: Gynecological Disorder
- Product Studied: Endo Relief Cream
- Research Institution: University of Newcastle
- Patient Population: Patient-Derived Organoids
- Location: Newcastle, Australia
- Type/Phase: Avatar Study
- Status: Initial Phase Underway, Patents Filed
Four patents filed following groundbreaking results in study of gynecological cancers
Groundbreaking results from the study
Ecofibre’s research partnership with the University of Newcastle was launched in early 2021 (Newcastle Pain Study). Despite the challenges of COVID-19, 31 patients have now participated in the study in a period of only seven months. All patients have responded positively to Ananda’s proprietary CBD formulation, as illustrated by the photos below which represent a sample of data collected.
The groundbreaking results from this clinical study using patient-derived organoids have led to four patent filings. The photos below demonstrate that diseased cells of varying gynecological diseases (CONTROL) were completely eradicated upon treatment with Ananda Health’s proprietary formulation (CBD Tx).



Successful responses shown above are consistent for all (31) patients to date.
Investing in new treatment and management options for gynecological diseases
Dr. Alex Capano, Chief Science Officer for Ecofibre states, “Women face a host of gynecological disorders for which there is currently no adequate method of treatment. Various forms of pelvic pain affect over 80% of women and are associated with infertility and poor health and socioeconomic outcomes.”
“Gynecological cancers account for over 15% of cancers diagnosed in women globally. They are frequently diagnosed in late stages, considerably aggressive, difficult to treat and often result in metastatic disease. The five-year survival rates for certain gyneacological cancers range from 17-39%. The need for improved therapeutic options is clear,” states Dr. Capano.
Professor Pradeep Tanwar, the NHMRC RD Wright Biomedical Fellow at the University of Newcastle states, “Our work with Ecofibre addresses a pressing unmet clinical need to provide new treatment and management options for gynecological diseases. Women with metastatic gynecological cancers have limited treatment options. The 5-year survival rate of many gynecological cancers is lower than other solid cancers and has not significantly improved in the last 20 years. We are excited about these initial results and now developing strong scientific rationale for the clinical application of CBD for various gynaecological disorders.”
Additional Background
Professor Pradeep Tanwar is an NHMRC RD Wright Biomedical Fellow within the School of Biomedical Science at the University of Newcastle.
He is an outstanding researcher who has established himself as a national and international leader in the field of gynecological cancers. In 2012, he relocated from Harvard Medical School to Newcastle and established the Global Centre for Gynecological Diseases (GCGD) by bringing together various researchers and clinicians working in different local hospitals and the university. Therefore, as a collective, GCGD now has the experience and clinical trials infrastructure in place required for translating project outcomes to patient treatment. The excellence of his research has been recognized by the award of three consecutive fellowships by NHMRC, ARC, and Cancer Institute NSW, >$9 million in funding support, and an exceptional publication record, including senior author papers in high-quality international journals. His papers are most often published in the top-ranking journals specific to the field of either Cancer Biology or Reproductive Biology, including Nature Genetics, Cell Stem Cell, PNAS x 4, Cell Reports x 2, Cancer Research. Significantly, several of his articles have received independent commentaries, cover page editions and are widely covered by the media. He also receives regular invitations to deliver high-profile plenary/invited talks at international and national conferences
Dr. Alex Capano
Alex Capano, DNP, CRNP, FNP-BC, is the Chief Science Officer of Ecofibre Limited, the global leader in hemp technologies that provides innovation solutions to address emerging health and resource sustainability issues.
4. Medical & supplement treatment receipt
The medical and supplement treatment receipt assumes collection of data regarding whether and how the participants use any hemp, CBD, or cannabis product.
At Ecofibre, Dr. Capano champions the company’s multi-million-dollar commitment to research to advance the clinical evidence of hemp extract. Ecofibre was the first hemp company to receive IND authorization from the FDA for research. Partnering with leading healthcare and academic institutions, Dr. Capano is currently researching CBD’s effects on CIPN, sleep, anxiety, addiction, gynecological disorders, certain cancers, and cognitive decline. Dr. Capano’s recent clinical trial concluded that CBD hemp extract could reduce opioid use and improve quality of life indicators in chronic pain patients.
Dr. Capano earned her DNP at Thomas Jefferson University in Philadelphia, Pennsylvania, where she graduated Summa Cum Laude and was awarded the Sandra Festa Ryan award for Outstanding Creativity and Innovation. She was the first doctoral candidate of any discipline who focused on cannabinoid science under the guidance of the Lambert Center for the Study of Medicinal Cannabis and Hemp. Dr. Capano also holds a BSN and an MSN from the University of Pennsylvania, and a BS from the University of Miami.
- Study Focus: Cognitive Decline
- Product Studied: Full Spectrum Softgels
- Research Institution: University of Colorado
- Patient Population: Adults, No Dementia
- Location: Boulder, CO
- Type/Phase: Phase II
- Status: Pending FDA Authorization-IND (expected 1Q22)