Systematically Testing the Evidence on Marijuana

Glioblastoma (GBM) is the most common malignant brain tumor among adults. As the diagnosis is generally considered terminal, patients with GBM often suffer from anxiety and other comorbid conditions, including depression, pain, and sleep disturbance, all of which significantly impact their quality of life. Previous studies have demonstrated the potential of cannabinoids, particularly cannabidiol (CBD), to improve the aforementioned symptoms without conferring significant risks or side effects. Further, recent in-vitro and in-vivo work suggests potential cytotoxic and anti-tumor effects of CBD and other cannabinoids. This study includes a double-blind, placebo-controlled, 8-week randomized clinical trial assessing the impact of a custom formulated, full-spectrum, hemp-derived ultra-high CBD product on measures of anxiety, pain, and quality of life in newly-diagnosed GBM patients undergoing standard of care (SOC) treatment; the impact of this product vs. placebo on tumor progression will also be assessed. The proposed clinical trial will provide important information that does not currently exist regarding the potential efficacy of a novel full-spectrum, ultra-high CBD product to address clinical symptoms in patients with GBM.

First Posted: March 3, 2023

Condition(s): Glioblastoma

Intervention(s): Cannabidiol (CBD), Placebo

Status: Not yet recruiting

Enrollment (expected or actual): 36

Allocation: Randomized

Sponsor: Mclean Hospital

Principal Investigator: Staci Gruber, Ph.D., Director, Marijuana Investigations for Neuroscientific Discovery; Director, Cognitive and Clinical Neuroimaging Core

Completion Date (primary or actual): September 2024

CT.gov Identifier: NCT05753007

POT-GFR-PK is a single dose pharmacokinetic study oral tetrahydrocannabinol (THC) and cannabidiol (CBD) in healthy adult controls and individuals with chronic kidney disease including those treated with in-center hemodialysis.

First Posted: February 24, 2023

Condition(s): Cannabis, Chronic Kidney Diseases, Dialysis

Intervention(s): Tetrahydrocannabinol-Cannabidiol Combination

Status: Recruiting

Enrollment (expected or actual): 24

Allocation: N/A

Sponsor: McMaster University

Principal Investigator:

Completion Date (primary or actual): December 31, 2023

CT.gov Identifier: NCT05742724

The primary goal of this study is to test the hypothesis that oral nabilone treatment will reduce agitation compared with placebo in patients with Frontotemporal Dementia (both behavioural variant frontotemporal dementia and primary progressive aphasia). The study population is defined as patients with probable Frontotemporal Dementia that meet the International Psychogeriatric Association criteria for agitation in cognitive disorders.

First Posted: February 24, 2023

Condition(s): Frontotemporal Dementia, Frontotemporal Dementia, Behavioral Variant, Primary Progressive Aphasia

Intervention(s): Nabilone, Placebo

Status: Not yet recruiting

Enrollment (expected or actual): 45

Allocation: Randomized

Sponsor: Simon Ducharme, MD

Principal Investigator: Simon Ducharme, MD, Associate Professor, McGill University

Completion Date (primary or actual): May 2025

CT.gov Identifier: NCT05742698

This study tests of effect of brief education and support about tobacco, e-cigarette, and cannabis waste (TECW) on knowledge, beliefs, behavior, and TECW on two college campuses.

First Posted: March 2, 2023

Condition(s): Knowledge, Attitudes, Practice

Intervention(s): Education plus Support

Status: Active, not recruiting

Enrollment (expected or actual): 400

Allocation: Randomized

Sponsor: California State University, San Marcos

Principal Investigator:

Completion Date (primary or actual): December 13, 2024

CT.gov Identifier: NCT05751369

This study plans to enroll participants with opioid use disorder who are not currently seeking treatment to assess the effects of cannabis on opioid withdrawal and other related outcomes.

First Posted: February 15, 2023

Condition(s): Opioid Use Disorder

Intervention(s): Inhaled vaporized cannabis, Intransal opioid

Status: Not yet recruiting

Enrollment (expected or actual): 15

Allocation: Randomized

Sponsor: University of Kentucky

Principal Investigator: Shanna Babalonis, PhD, Principal Investigator

Completion Date (primary or actual): August 2026

CT.gov Identifier: NCT05729932

This is a proof-of-concept of a new Virtual Reality (VR) Avatar Intervention for Cannabis Use Disorders (CUD) in patients with psychotic disorders and/or mood disorders. The primary outcomes are reductions in cannabis use, cannabis use disorder severity, and increased quality of life.

First Posted: February 14, 2023

Condition(s): Psychotic Disorders, Cannabis Use Disorder, Mental Health Disorder

Intervention(s): Avatar Intervention

Status: Active, not recruiting

Enrollment (expected or actual): 32

Allocation: N/A

Sponsor: Ciusss de L'Est de l'Île de Montréal

Principal Investigator:

Completion Date (primary or actual): August 11, 2022

CT.gov Identifier: NCT05726617

In this trial we will work with a group of participants who are having problems related to marijuana use (they have Cannabis Use Disorder) and who want to reduce the amount of marijuana they use or quit using marijuana completely. We are testing to see if a treatment called repetitive transcranial magnetic stimulation (rTMS) can help them achieve that goal when combined with a brief three-session counseling therapy. Participants will receive rTMS to one of two different parts of the brain (the dorsolateral prefrontal cortex--the DLPFC or the ventromedial prefrontal cortex--the vmPFC) to see if applying rTMS to one brain area is more helpful than the other brain area.

First Posted: February 9, 2023

Condition(s): Cannabis Use Disorder

Intervention(s): Repetitive Transcranial Magnetic Stimulation (rTMS)

Status: Not yet recruiting

Enrollment (expected or actual): 30

Allocation: Randomized

Sponsor: Stanford University

Principal Investigator: Gregory Sahlem, Assistant Professor of Psychiatry

Completion Date (primary or actual): April 1, 2024

CT.gov Identifier: NCT05720312

Insomnia is a common sleep disorder in which a person has difficulty falling asleep or staying asleep or getting good quality sleep. Consequences of insomnia include daytime sleepiness, poor memory function, decline in concentration with negative impacts on social and work activities. Although medical cannabis and cannabis products are widely used worldwide for the management of symptoms associated with insomnia, there is little clinical data available to support the efficacy or utility of CBD in the management of sleep disorders. The proposed study will assess whether nightly doses of 75mg or 150mg of an 8 week period are able to improve patient reported sleep quality when compared to a placebo.

First Posted: May 3, 2023

Condition(s): Insomnia

Intervention(s): Cannabidiol

Status: Not yet recruiting

Enrollment (expected or actual): 540

Allocation: Randomized

Sponsor: Avecho Biotechnology

Principal Investigator:

Completion Date (primary or actual): March 2024

CT.gov Identifier: NCT05840822

The goal of this clinical trial is to conduct a single-blind randomized controlled trial to verify whether the Avatar Intervention has greater efficacy over supportive intervention to reduce cannabis use in patients with psychotic disorders.

First Posted: January 30, 2023

Condition(s): Psychotic Disorders, Cannabis Use Disorder, Mental Health Disorder

Intervention(s): Avatar Intervention, Addiction supportive intervention

Status: Recruiting

Enrollment (expected or actual): 150

Allocation: Randomized

Sponsor: Ciusss de L'Est de l'Île de Montréal

Principal Investigator:

Completion Date (primary or actual): January 2027

CT.gov Identifier: NCT05704582

The goal of this open-label clinical trial is to compared two different doses for treating menstrual-related symptoms in individuals who experience regular menstrual cycles (occurring for 4-8 days every 21-28 days). The main question it aims to answer is: (1) if there are changes in menstrual-related symptoms from baseline compared to all 3-months of cannabidiol (CBD) isolate consumption. Participants will complete a monthly baseline measure after they stop menstruating followed by taking CBD twice daily (BID) for five days for three menstrual cycles and complete the same measures. Researchers will compare 160mg of daily CBD isolate to 320mg of CBD isolate to see if there are differential effects on menstrual-related symptoms (MRS).

First Posted: January 11, 2023

Condition(s): Menstrual Discomfort

Intervention(s): Cannabidiol

Status: Completed

Enrollment (expected or actual): 33

Allocation: Randomized

Sponsor: Canopy Growth Corporation

Principal Investigator:

Completion Date (primary or actual): September 23, 2021

CT.gov Identifier: NCT05679830

Given the treatments that are available today for HIV disease, people living with HIV (PLWH) can generally expect good medical outcomes. However, HIV is still a chronic disease and there are remaining barriers to achieving ideal health status and quality of life. One barrier may be a condition that is common among PLWH, called alexithymia, which can make it difficult for a person to name and describe the emotions that they are feeling. As a result, it is difficult to resolve negative emotional states, which can then lead to worse outcomes over time due to ongoing stress and related problems such as inflammation. In this study we will try to find out whether taking cannabidiol (CBD) helps PLWH who have alexithymia to resolve those negative emotional states, which may then reduce inflammation in the body as a result. CBD may work by enhancing the body's own chemical messengers that can help to regulate emotions and encourage emotional benefits. We will compare a group of people who take CBD for 4 weeks to those who take a placebo, which is a substance that will closely resemble the CBD but will not contain any active drug. Study participants and the researchers who are working directly with the participants will not be able to tell which is the CBD and which is the placebo. We will evaluate participants before and after the 4-week study period. We will also collect samples, such as blood, so that we can measure inflammation. We will compare the two groups to see if those who took CBD have lower alexithymia and lower inflammation compared to those who took the placebo. The potential benefit of this study is that CBD may be an effective treatment for alexithymia in PLWH, which may then improve both their emotional and physical health outcomes. This can help to address a remaining barrier to good medical outcomes for PLWH.

First Posted: April 27, 2023

Condition(s): Alexithymia, HIV

Intervention(s): Synthetic CBD, Placebo

Status: Not yet recruiting

Enrollment (expected or actual): 30

Allocation: Randomized

Sponsor: University of California, San Diego

Principal Investigator: Erin Morgan, Assistant Professor of Psychiatry

Completion Date (primary or actual): April 1, 2024

CT.gov Identifier: NCT05832281

The objective of this work is to conduct a randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of cannabis extract in women with endometriosis who have already undergone hormonal contraceptive treatment and surgery without satisfactory response.

First Posted: January 4, 2023

Condition(s): Endometriosis, Pelvic Pain

Intervention(s): Cannabis Derivatives, Placebo, Hormonal Contraceptive Agents

Status: Recruiting

Enrollment (expected or actual): 102

Allocation: Randomized

Sponsor: University of Sao Paulo

Principal Investigator: Omero Benedicto Poli Neto, Prof. Dr.

Completion Date (primary or actual): August 20, 2023

CT.gov Identifier: NCT05670353

This study will be the first in vivo human multimodal neuroimaging study exploring the relationship between mGluR5 availability (PET), neural oscillations (EEG), and cognitive function in people with CUD. The goal is to test the overall hypothesis that mGluR5 availability is higher in people with CUD compared with HC. In Aim 1, the investigators will determine differences in mGluR5 availability between people with CUD and HC in the fronto-limbic brain circuit. Aim 2 examines the associations between mGluR5 availability, CUD severity, neural oscillations, and cognitive function in CUD subjects. Aim 3 will determine how prolonged abstinence from chronic cannabis use affects mGluR5 availability, neural oscillations, and cognitive function in CUD subjects.

First Posted: December 27, 2022

Condition(s): Cannabis Use Disorder

Intervention(s): [18F]FPEB with PET, Cannabis abstinence

Status: Recruiting

Enrollment (expected or actual): 60

Allocation: Non-Randomized

Sponsor: Yale University

Principal Investigator: Stephen Baldassarri, Assistant Professor of Medicine

Completion Date (primary or actual): February 28, 2028

CT.gov Identifier: NCT05664763

The purpose of this study is to evaluate the preliminary effects and impacts of a digital educational intervention to support nurses' professional practice regarding safe cannabis use by young adults (18-39 years) diagnosed with cancer.

First Posted: December 23, 2022

Condition(s): Cannabis Use, Cannabis Use, Unspecified, Nurse's Role, Oncology Pain, Symptoms and Signs

Intervention(s): Cannabis & Cancer digital educational intervention, Standard information regarding cannabis use in oncology

Status: Not yet recruiting

Enrollment (expected or actual): 70

Allocation: Randomized

Sponsor: Ciusss de L'Est de l'Île de Montréal

Principal Investigator:

Completion Date (primary or actual): April 2023

CT.gov Identifier: NCT05663346

The purpose of this study is to test whether a single-dose of Epidiolex (cannabidiol) is associated with reduced psychological, physiological, and neuroimaging measures of anxiety in people diagnosed with social anxiety disorder (SAD).

First Posted: December 13, 2022

Condition(s): Phobia, Social

Intervention(s): Cannabidiol, Placebo

Status: Not yet recruiting

Enrollment (expected or actual): 50

Allocation: Randomized

Sponsor: Massachusetts Institute of Technology

Principal Investigator:

Completion Date (primary or actual): September 2024

CT.gov Identifier: NCT05649059

Hereditary epidermolysis bullosa (HEB) is a heterogeneous group of rare genetic diseases, characterized by fragility of the skin and mucous membranes, which results in the appearance of mucocutaneous bullae and erosions during minimal trauma. Pruritus is a neuropathic pain mainly related to activation of unmyelinated cutaneous C nerve fibers and is very common in patients with HEB. It is the cause of trophic disorders, aggravation of certain wounds, appearance of new bubbles. In addition, this chronic pruritus can also have a major psychological impact on the patient and his family. However, these therapies used in the pruritus of patients with HEB have often proven to be ineffective. In order to improve the quality of life of children and their families, research into new therapies to limit this chronic pruritus is necessary. Among phytocannabinoids, CANNABIDIOL (CBD) should be clearly distinguished from Delta-9-tetrahydrocannabinol (THC). Indeed, CBD is an "inverse" agonist of the CB2 receptor, it acts by reducing the effect of this receptor, while THC is an agonist of the CB1 and CB2 receptors. Thus, CBD has antipsychotic, anxiolytic, antiemetic, anti-inflammatory and anti-epileptic effects, unlike THC which has psychotic, relaxation effects, impairs cognitive function and memory. Cannabinoids are involved in the physiopathology in pruritus at the level of the peripheral nervous system via the CB1 and TRPV1 receptors, and also at the level of the central nervous system thanks to the CB1 and CB2 receptors. In addition, inflammation plays an important role in the physiopathology of pruritus and this is reduced via the activation of CB2 receptors, expressed in immune cells. Various studies with promising results have examined the effect of cannabinoids in pruritus. No serious adverse effects have been reported and the rare adverse effects that have been observed are reversible upon discontinuation of treatment. The research project seeks to estimate the efficacy of CANNABIDIOL in the pruritus of 10 children with severe hereditary epidermolysis bullosa. Pruritus is assessed before the start of treatment, then after one month of taking oral treatment, three times a day. The effectiveness of taking the treatment will also be assessed on pain, on the impact on sleep and on overall quality of life. The tolerance of CANNABIDIOL will be well monitored. The systemic passage of CANNABIDIOL is measured during a routine blood test 1 month after treatment.

First Posted: December 15, 2022

Condition(s): Hereditary Epidermolysis Bullosa

Intervention(s): Cannabidiol

Status: Not yet recruiting

Enrollment (expected or actual): 10

Allocation: N/A

Sponsor: Assistance Publique - Hôpitaux de Paris

Principal Investigator:

Completion Date (primary or actual): November 2023

CT.gov Identifier: NCT05651607

This is a multicenter randomized double-blind placebo-controlled Phase 2 study of an oral combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) compared to placebo over 12 weeks. This study is designed to test the hypothesis that treatment with an oral combination of THC/CBD will reduce agitation hospice care-eligible patients with agitation and dementia as measured by the Cohen Mansfield Agitation Inventory (CMAI) when compared to placebo at 2 weeks. This study will enroll approximately 150 participants of any gender at least 40 years of age who are hospice care-eligible with agitation and dementia (HAD). Participants will be randomized (50:50) to either active study drug (T2:C100) or placebo. The double-blind period of this study is 12 weeks. A 24 week optional open-label extension will be offered to participants who complete the double-period.

First Posted: December 9, 2022

Condition(s): Agitation, Dementia

Intervention(s): T2:C100, Placebo

Status: Not yet recruiting

Enrollment (expected or actual): 150

Allocation: Randomized

Sponsor: University of Southern California

Principal Investigator: Paul Aisen, Professor

Completion Date (primary or actual): December 2025

CT.gov Identifier: NCT05644262

10 adult patients who have undergone nasal reconstructive surgery and had skin from their forehead used to cover this wound will be asked to participate. Treatment will be of the scar on their forehead, using a silicone ointment, on half of the scar, and CBD oil + silicone ointment, on the second half. Pictures will be taken during the treatment of the scar and questionnaires will be completed. Also, doctors will look at the pictures taken during the healing process and grade the healing of the scar areas.

First Posted: December 14, 2022

Condition(s): Forehead; Wound

Intervention(s): Group 1 cannabidiol (CBD) oil with silicone ointment, Group 2 cannabidiol (CBD) oil with silicone ointment

Status: Not yet recruiting

Enrollment (expected or actual): 10

Allocation: Randomized

Sponsor: University of Oklahoma

Principal Investigator: Mark Mims, Assistant Professor

Completion Date (primary or actual): December 2024

CT.gov Identifier: NCT05650697

The purpose of this study is to determine if CBD has any effect on local inflammation in periodontal maintenance patients. This research is significant and innovative as it will act as a pivotal study to determine if CBD is worthy of further study in the area of periodontal disease and it will be a human clinical trial focusing on a specific aspect of periodontal disease, the maintenance patient. Many successful therapies exist for the active, untreated periodontal patient. Unfortunately, periodontology has not yet discovered a therapy that will predictably treat local inflammation in these patients which are at risk for further pocketing, bleeding on probing, bone loss and ultimately, tooth loss. Although CBD has been patented in various forms since the 1940s, its acceptance and availability to patients has only recently expanded exponentially. Marketing of CBD to periodontal patients as a means to control inflammation is already commonplace online and in CBD-specific shops; it is the duty of periodontology to determine the efficacy and success of this known anti-inflammatory compound as it relates to clinical periodontal parameters. To determine if CBD is a successful adjunct to conventional periodontal inflammation control therapies would be a boon to the advancement of oral health and to millions of patients that could benefit from this treatment.

First Posted: December 12, 2022

Condition(s): Periodontitis, Adult, Inflammation Gum

Intervention(s): cannabidiol, floss, proxabrush

Status: Withdrawn

Enrollment (expected or actual): 0

Allocation: Randomized

Sponsor: University of Nebraska

Principal Investigator: Amy C. Killeen, DDS, MS, Associate Professor

Completion Date (primary or actual): June 2020

CT.gov Identifier: NCT05646459

The main purposes of this study are to (1) measure the effect of CBD on pain symptoms, pain intensity, pain unpleasantness, and skin sensitivity to hot and cold temperature; and (2) measure the effect of CBD on brain electrical activity with electroencephalography (EEG).

First Posted: November 29, 2022

Condition(s): SCI - Spinal Cord Injury, Neuropathic Pain

Intervention(s): CBD, Placebo

Status: Not yet recruiting

Enrollment (expected or actual): 15

Allocation: Randomized

Sponsor: University of Miami

Principal Investigator: Eva Widerstrom-Noga, Research Professor

Completion Date (primary or actual): December 1, 2023

CT.gov Identifier: NCT05630235

In France, consumption levels of alcohol, tobacco and cannabis remain high despite changes in regulations aimed at limiting access to these products and repeated prevention campaigns. The various Presidential Plans for the treatment and prevention of addictions for 2007-2011 and 2018-2022 show the concern of the public authorities on the issue of multiple consumption, encouraging general practitioners to identify and research this issue. In order to better identify and evaluate high-risk cannabis use, the French Observatory for Drugs and Drug Addiction has developed a detection tool: The Cannabis Abuse Screening Test (CAST). Although recommended in France, this questionnaire has never been tested in real primary care conditions, directly with patients consulting general medicine. The main objective of this study is the validation of a scale for the identification of problematic cannabis use, CAST, with a response modality according to a Likert scale (rated from 0 to 4 : 0 "never", 1 "rarely", 2 "occasionally", 3 "quite often", 4 "very often") or a binary response modality (response by 1 "Yes" or 0 "No") in patients who have used cannabis in the past 12 months, followed in general practice and in 3 age categories (15-18 years, 18-25 years and 25-45 years). The secondary objective is to analyze the polydrug use of alcohol and tobacco, and then the relationship between them and the level of cannabis use. This validation study of diagnostic scales in real-life situations with general medicine patients allows us to focus on the human and social sciences and public health. Although it has now been established that there is a synergy between several addictive substances with respect to cancer risks, few studies have focused on the early identification of misuse or polydrug use. However, it has been shown that general practitioners (GPs) are effective and relevant players in these fields. Because of their holistic vision of the patient, GPs are in the best position to identify consumers at risk of complications without blaming, dramatizing or trivializing. It is therefore necessary to provide GPs with early detection tools to promote contact between these patients and the healthcare system.

First Posted: December 1, 2022

Condition(s): Cannabis, Addictive Behavior, General Practice, Primary Care, Substance-Related Disorders, Questionnaires

Intervention(s):

Status: Not yet recruiting

Enrollment (expected or actual): 660

Allocation:

Sponsor: University Hospital, Clermont-Ferrand

Principal Investigator:

Completion Date (primary or actual): January 1, 2024

CT.gov Identifier: NCT05633043

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 alcohol use disorder. If eligible for the study, subjects will be randomized to receive one of the conditions for 12 weeks.

First Posted: November 14, 2022

Condition(s): Alcohol Use Disorder

Intervention(s): Cannabidiol, Placebo

Status: Recruiting

Enrollment (expected or actual): 180

Allocation: Randomized

Sponsor: University of Colorado, Denver

Principal Investigator:

Completion Date (primary or actual): April 2027

CT.gov Identifier: NCT05613608

The goal of this clinical trial is to study the effects of dronabinol in US Veterans with agitation related to moderate to severe dementia. The main goals of the study are: To evaluate the efficacy of dronabinol for the treatment of agitation in moderate to severe dementia compared to placebo To evaluate the safety of dronabinol in the treatment of agitation in moderate to severe dementia compared to placebo Fifty (50) subjects will be given either dronabinol or placebo for 8 weeks. All subjects will then undergo a "washout" phase for 3 weeks, followed by the crossover intervention (i.e. subjects who received placebo during the first phase will receive dronabinol during the second phase, and vice versa). Thus, all participants will be taking dronabinol at some point during the study. During the study, subjects will undergo evaluations for: Agitation Cognitive changes Physical changes (i.e. labs, ekg, physical exam)

First Posted: November 10, 2022

Condition(s): Dementia Moderate, Dementia Severe, Agitation,Psychomotor, Behavioral Symptoms

Intervention(s): Dronabinol

Status: Not yet recruiting

Enrollment (expected or actual): 50

Allocation: Randomized

Sponsor: Ralph H. Johnson VA Medical Center

Principal Investigator: Jacobo Mintzer, MD, Professor, Geriatric Psychaitrist

Completion Date (primary or actual): November 2025

CT.gov Identifier: NCT05612711

This is an 18 to 54 week study assessing the efficacy of Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) on the severity of autism spectrum disorder in young people.

First Posted: November 25, 2022

Condition(s): Autism Spectrum Disorder

Intervention(s): NTI164

Status: Not yet recruiting

Enrollment (expected or actual): 54

Allocation: Randomized

Sponsor: Fenix Innovation Group

Principal Investigator:

Completion Date (primary or actual): March 1, 2023

CT.gov Identifier: NCT05626959

This study will examine the pharmacokinetics and pharmacodynamics of delta-9-tetrahydrocannabinol (THC)-infused chocolates, gummies, and drinks. Healthy adults (N=40) will complete 9 drug administration sessions, including an overnight stay prior to each session. Participants will consume THC containing products in a fasted state; following drug administration, the participants will complete cognitive and psychomotor tasks, subjective assessments, have blood collected, and vital signs monitored.

First Posted: November 2, 2022

Condition(s): Cannabis Use

Intervention(s): Cannabis, Placebo

Status: Not yet recruiting

Enrollment (expected or actual): 80

Allocation: Randomized

Sponsor: Johns Hopkins University

Principal Investigator:

Completion Date (primary or actual): January 2026

CT.gov Identifier: NCT05602649