Industry Leaders in Clinical Hemp Research

When you choose Ananda Hemp, 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 safety) 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. CBD extract has only been around for human use for a few years, studying it gives insight into how it works

4. Completing this research means millions of people can use CBD for health conditions, forgoing more dangerous or addictive alternatives


$40M+

Invested in research to advance the clinical evidence of hemp extract


7

Clinical trials ongoing 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-Published 2019 in Journal Postgraduate Medicine

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 Hemp 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)

CIPN (Chemotherapy-Induced Peripheral Neuropathy)

The purpose of this study is to assess the effect of a hemp-based cannabidiol (CBD) product, Ananda Hemp 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 2

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 Hemp 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: THC free Softgels

Research Institution: Eastern Virginia Medical School

Patient Population: Dementia

Location:Norfolk, VA

Type/Phase:Phase 2

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:Full Spectrum Softgels

Research Institution: Southern Cross University

Patient Population: Healthy Population

Location:Australia (4 sites)

Type/Phase:Phase 2b

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 2

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.

Pain (endometriosis)

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: University of Newcastle

Patient Population: Endometriosis

Location:Newcastle, Australia

Type/Phase:Avatar Study

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 interstitial cystitis, urinary tract infection, pelvic inflammatory disease, uterine fibroids, 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

Agarwal, S. K., Antunez-Flores, O., Foster, W. G., Hermes, A., Golshan, S., Soliman, A. M., ... & Luna, R.(2021). Real-world characteristics of women with endometriosis-related pain entering a multidisciplinary endometriosis program. BMC Women's Health, 21(1), 1-14.

Armour, M., Parry, K., Al-Dabbas, M. A., Curry, C., Holmes, K., MacMillan, F., ... & Smith, C. A. (2019). Self-care strategies and sources of knowledge on menstruation in 12,526 young women with d ysmenorrhea: A systematic review and meta-analysis. PLoS One, 14(7), e0220103

Armour, M., Parry, K., Manohar, N., Holmes, K., Ferfolja, T., Curry, C., ... & Smith, C. A. (2019). The prevalence and academic impact of dysmenorrhea in 21,573 young women: a systematic review and meta-analysis. Journal of women's health, 28(8), 1161-1171.

Armour, M., Sinclair, J., Chalmers, K. J., & Smith, C. A. (2019). Self-management strategies amongst Australian women with endometriosis: a national online survey. BMC complementary and alternative medicine, 19(1), 1-8.

Bouaziz, J., Bar On, A., Seidman, D. S., & Soriano, D. (2017). The clinical significance of endocannabinoids in endometriosis pain management. Cannabis and cannabinoid research, 2(1), 72-80.

De Sanctis, V., Soliman, A., Bernasconi, S., Bianchin, L., Bona, G., Bozzola, M., ... & Perissinotto, E. (2015). Primary dysmenorrhea in adolescents: Prevalence, impact and recent knowledge. Pediatric endocrinology reviews: PER, 13(2), 512-520.

Di Blasio, A. M., Vignali, M., & Gentilini, D. (2013). The endocannabinoid pathway and the femalereproductive organs. Journal of molecular endocrinology, 50(1), R1-R9.

Dmitrieva, N., Nagabukuro, H., Resuehr, D., Zhang, G., McAllister, S. L., McGinty, K. A., ... & Berkley, K.J. (2010). Endocannabinoid involvement in endometriosis. PAIN®, 151(3), 703-710.

Durand, H., Monahan, K., & McGuire, B. E. (2021). Prevalence and impact of dysmenorrhea among University students in Ireland. Pain Medicine.

Dydyk, A. M., & Gupta, N. (2020). Chronic Pelvic Pain.

Grandi, G., Ferrari, S., Xholli, A., Cannoletta, M., Palma, F., Romani, C., ... & Cagnacci, A. (2012). Prevalence of menstrual pain in young women: what is dysmenorrhea?. Journal of pain research, 5, 169.

Leconte, M., Nicco, C., Ngô, C., Arkwright, S., Chéreau, C., Guibourdenche, J., ... & Batteux, F. (2010). Antiproliferative effects of cannabinoid agonists on deep infiltrating endometriosis. The American journal of pathology, 177(6), 2963-2970.

Randhawa, A. E., Tufte-Hewett, A. D., Weckesser, A. M., Jones, G. L., & Hewett, F. G. (2021). Secondary School Girls’ Experiences of Menstruation and Awareness of Endometriosis: A Cross-Sectional Study. Journal of Pediatric and Adolescent Gynecology.

Schoep, M. E., Adang, E. M., Maas, J. W., De Bie, B., Aarts, J. W., & Nieboer, T. E. (2019). Productivity loss due to menstruation-related symptoms: a nationwide cross-sectional survey among 32 748 women. BMJ open, 9(6), e026186.

Schoep, M. E., Adang, E. M., Maas, J. W., De Bie, B., Aarts, J. W., & Nieboer, T. E. (2019). Productivity loss due to menstruation-related symptoms: a nationwide cross-sectional survey among 32 748 women. BMJ open, 9(6), e026186.

Steel, A., McIntyre, E., Harnett, J., Foley, H., Adams, J., Sibbritt, D., ... & Frawley, J. (2018). Complementary medicine use in the Australian population: Results of a nationally-representative cross-sectional survey. Scientific reports, 8(1), 1-7.

Subasinghe, A. K., Happo, L., Jayasinghe, Y. L., Garland, S. M., & Wark, J. D. (2016). Prevalence and severity of dysmenorrhoea, and management options reported by young Australian women. Australian family physician, 45(11), 829-834.

Tanaka, K., Mayne, L., Khalil, A., Baartz, D., Eriksson, L., Mortlock, S. A., ... & Amoako, A. A. (2020). The role of the endocannabinoid system in aetiopathogenesis of endometriosis: A potential therapeutic target. European journal of obstetrics & gynecology and reproductive biology, 244, 87-94.

Webster, E. M., Yadav, G. S., Gysler, S., McNamara, B., Black, J., Tymon-Rosario, J., ... & Altwerger, G. (2020). Prescribed medical cannabis in women with gynecologic malignancies: A single-institution survey-based study. Gynecologic Oncology Reports, 34, 100667.

World Health Organization (2018). Critical Review Report: Cannabidiol. Expert Committee on Drug Dependence Fortieth Meeting.

Zondervan, K. T., Yudkin, P. L., Vessey, M. P., Jenkinson, C. P., Dawes, M. G., Barlow, D. H., & Kennedy, S. H. (2001). The community prevalence of chronic pelvic pain in women and associated illness behaviour. British Journal of General Practice, 51(468), 541-547.

Cognitive Decline

Coming soon

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 2

Status:Pending FDA Authorization-IND (expected 1Q22)

Inspired by Katelyn Lambert

Katelyn Lambert was diagnosed with Dravet Syndrome at the age of two in 2014. This life-changing event for our Chairman, Barry Lambert and his family, was only the beginning. shortly after Katelyn Lambert's seizures were under control, they set off a chain of events that would see their vision to research, educate and ultimately ensure all australians could access high-quality afforable CBD become a reality.

A Story of Hemp and Hope: Barry Lambert

Our mission has been simple from the beginning. Here at Ananda Hemp, family has always been a core value. Our company was created as an answer to a very complicated problem. With a little ingenuity and a whole lot of love, what started as little hope led to something much bigger than anyone could have imagined.

Barry Lambert and a Struggling Angel

Barry Lambert, until a few years ago, was known primarily as a successful Australian businessman who built Count Financial, Australia’s largest network of accounting-based advisory firms. Today he is known as the philanthropic chairman of Ecofibre Limited, Ananda Hemp’s parent company.

His love for his family is what brought him to the world of hemp. The story of Ananda Hemp would not be complete without Barry Lambert. Because of him, we have all been lucky enough to witness a world of possibility.

Barry’s granddaughter, Katelyn Lambert, at six months old was diagnosed with a rare condition - which is the result of a spontaneous genetic mutation. In almost all cases, the condition leads to intellectual disability and huge probability of death before adulthood. Currently, there is no cure.

Conventional medical treatments were not helping Katelyn so the family, desperate for help, turned to medical cannabis. Medical cannabis has been shown to be one of the few therapies that mitigates the condition, and cannabis derived from hemp gave Katelyn substantial relief.

As soon as Katelyn took it, her family watched as her condition improved. However, given their residence in New South Wales, Australia, medical cannabis was highly illegal under the NSW Drug Misuse and Trafficking Act of 1985 (which prohibits the cultivation, manufacture, supply, possession and use of certain drug - including cannabis). The law also increased the maximum penalty for offences involving supply to persons under 16 years.

Barry Lambert, Philanthropist

For Barry, watching his family struggle was unacceptable. In 2015, Barry and his wife, Joy made one of the largest donations to the University of Sydney in Australian history - $33.7 million, for research into the therapeutic use of medicinal cannabis.

Aptly named the 'Lambert Initiative,' Barry Lambert’s donation has been established for “advancing cannabinoid-based treatments to alleviate human suffering.” The Lambert Initiative is an Australian first in the field of medicinal cannabinoids.

Then in 2016, the Lambert’s gifted $3 million to The Institute of Emerging Health Professions at Thomas Jefferson University to support its Center for Medical Cannabis Education and Research. It was renamed The Lambert Center for the Study of Medicinal Cannabis and Hemp at Thomas Jefferson University, and its mission is to advance the clinical use of cannabis-derived medicinal therapies.

Ecofibre Limited, Australia

In his search for a healthy alternative to treat his granddaughter, Barry found Ecofibre. Ecofibre is an Australian genetics development company with over 20 years growing and breeding experience. It owns one of the largest and most diverse collections of hemp seed genetics with over 300 landrace species of cannabis from around the world.

Barry believed that Ecofibre’s combination of refining technology and specially bred hemp strains could be the start of a lucrative Australian industry, so in 2015, he invested in the company.

Although Ecofibre could legally develop the genetics of hemp, they couldn’t legally turn it into a product that would help Katelyn, so Barry alongside Ecofibre, decided to go to where it was legal.

Ananda Hemp, Kentucky, United States

Kentucky, United States was the first state to create sponsored industrial hemp pilot programs allowing tobacco farmers to legally grow hemp under the 2014 Farm Bill. These pilot programs were designed to test the agronomics of the crop, and what it could mean to farmers and processors who want to enter the industry.

Barry flew to Kentucky to inspect a joint venture between Ecofibre and US tobacco farmers who were part of the pilot program in the United States. The pilot program allowed for companies to legally grow, market and sell hemp under the program. Barry made his investment decision within 24 hours, and in 2015, Ananda Hemp was born!

Search