Systematically Testing the Evidence on Marijuana

This clinical trial tests how well phytocannabinoids (cannabidiol [CBD] and tetrahydrocannbinol [THC]) work in reducing chronic chemotherapy-induced peripheral neuropathy (CIPN) in breast and colon cancer survivors. Neuropathy is the most common neurological symptom reported by cancer patients due to treatment. A variety of pharmacologic treatments have been evaluated to alleviate CIPN symptoms; however, no definitive treatment has been found to successfully treat all the symptoms of CIPN. Therefore, investigators continue to seek other possible treatment options including cannabis. Phytocannabinoids may be a particularly useful intervention for cancer patients given the limited effective treatments for CIPN. In addition, cannabis-based medicines have become tremendously popular as both cancer patients and clinicians are seeking therapies with fewer potential risks of dependency and other side effects. This trial is being done to provide cancer patients and clinicians with reliable information to help guide their use of phytocannabinoids to manage the tremendous distress and pain experienced by many cancer patients, which impacts their long-term quality of life.

First Posted: January 5, 2023

Condition(s): Breast Carcinoma, Chemotherapy-Induced Peripheral Neuropathy, Colon Carcinoma

Intervention(s): Cannabidiol, Delta-8-Tetrahydrocannabinol, Placebo Administration, Questionnaire Administration

Status: Not yet recruiting

Enrollment (expected or actual): 120

Allocation: Randomized

Sponsor: City of Hope Medical Center

Principal Investigator:

Completion Date (primary or actual): October 31, 2024

CT.gov Identifier: NCT05672342

The goal of this pilot study is to explore the feasibility and acceptability of a medicinal cannabis clinical trial into easing the symptoms of children undergoing palliative care for non-oncological conditions. The trial will evaluate the study design including recruitment strategy, medication tolerability, duration and outcomes to determine acceptability and feasibility for participating families. The data collected will then be used to design a full-scale multi-centre trial. Participants will be randomly allocated to receive one of two medicinal cannabis products. Neither the participants nor researchers will know the study drug allocation until the end of the trial.

First Posted: November 14, 2022

Condition(s): Palliative Care

Intervention(s): Medicinal Cannabis - C12T12, Medicinal Cannabis - C20T5

Status: Not yet recruiting

Enrollment (expected or actual): 10

Allocation: Randomized

Sponsor: Murdoch Childrens Research Institute

Principal Investigator:

Completion Date (primary or actual): February 2024

CT.gov Identifier: NCT05615389

The present study aims to address disparities in cannabis use outcomes among African American/Black (hereby referred to as Black) adults with cannabis use disorder (CUD). The specific aims of this study are: (1) to develop a culturally adapted, mobile app for Black cannabis users (CT-MICART) using knowledge from the current research team, published literature, expert opinion, and feedback from the Community Research Advisory Board (CRAB), (2) to pilot test CT-MICART and (3) focus on analysis of data collected as part of Aim 2.

First Posted: October 4, 2022

Condition(s): Cannabis Use

Intervention(s): CT-MICART App, Control

Status: Not yet recruiting

Enrollment (expected or actual): 50

Allocation: N/A

Sponsor: University of Houston

Principal Investigator: Lorra Garey, Principal Investigator

Completion Date (primary or actual): August 23, 2023

CT.gov Identifier: NCT05566730

CBD may affect metabolic control and energy intake. However, there is currently little data regarding these specific outcomes in humans. Therefore, this study will investigate whether a single 300 mg dose of CBD can improve metabolic control following a meal and/or reduce energy intake at a subsequent meal. Healthy, adult volunteers will complete two conditions in a crossover design, comparing outcomes following both CBD and placebo supplementation.

First Posted: November 16, 2022

Condition(s): Glucose Metabolism Disorders (Including Diabetes Mellitus), Lipid Metabolism Disorders, Appetitive Behavior

Intervention(s): Acute oral CBD supplementation, Acute oral placebo supplementation

Status: Recruiting

Enrollment (expected or actual): 20

Allocation: Randomized

Sponsor: Loughborough University

Principal Investigator: Lewis James, Senior Lecturer in Nutrition

Completion Date (primary or actual): April 30, 2023

CT.gov Identifier: NCT05618756

Co-administration of cannabis and tobacco is a common practice, but there is little experimental evidence aimed at understanding the reasons for this prevalence. Some preliminary evidence suggests that tobacco may actually counteract the cognitive-impairing effects of cannabis, and may also increase the subjective ('liking') effects of cannabis, but results are inconclusive. Further, there are no studies into the effects of tobacco on other cannabis-related harms such as driving, or on the ability of tobacco to alter the blood levels of THC, the chemical responsible for the psychoactive properties of cannabis. The purpose of the present study will be to evaluate the effects of tobacco, cannabis or combinations of tobacco and cannabis on driving, cognition, subjective effects and blood THC. Driving will be assessed using a state-of-the-art driving simulator that allows for the safe and objective measurement of the effects of intoxicating substances on driving. Participants will be regular users of cannabis and will be invited to the lab for four counterbalanced test sessions. In these test sessions they will drive the simulator and undergo cognitive tests before and after smoking: 1) cannabis; 2) tobacco; 3) cannabis + tobacco; or 4) placebo. Outcomes will be measured at several time points after smoking the product. Participants will also give blood for determination of levels of THC, and will complete subjective effects questionnaires both before and after smoking the cigarette. This study will be one of the first experimental laboratory studies of the reasons behind co-administration of tobacco and cannabis.

First Posted: September 2, 2022

Condition(s): Driving Under the Influence

Intervention(s): Cannabis, Tobacco, Cannabis tobacco, Placebo

Status: Not yet recruiting

Enrollment (expected or actual): 60

Allocation: Non-Randomized

Sponsor: Centre for Addiction and Mental Health

Principal Investigator:

Completion Date (primary or actual): February 1, 2027

CT.gov Identifier: NCT05526196

This NIH funded study will enroll 20 pregnant women in an Open Trial and 50 pregnant women in an RCT who are at high risk for prenatal cannabis use. Participants will be assigned to either: (1) a 12-week Lifestyle Physical Activity plus Fitbit (LPA+Fitbit) intervention or (2) a Fitbit Only condition. The investigators will clinically monitor all participants in the study for safety and clinical deterioration, and measure a variety of symptom outcomes over the course of the intervention period during pregnancy, as well as at a postpartum follow-up.

First Posted: September 6, 2022

Condition(s): Pregnancy, Cannabis

Intervention(s): LPA+Fitbit intervention, Fitbit Only

Status: Not yet recruiting

Enrollment (expected or actual): 70

Allocation: Randomized

Sponsor: Butler Hospital

Principal Investigator:

Completion Date (primary or actual): May 2025

CT.gov Identifier: NCT05528380

The randomised controlled study on regulated cannabis access in pharmacies in Basel aims to investigate the effects of regulated cannabis access on consumption behaviour and mental and physical health in comparison to the illegal market.

First Posted: August 30, 2022

Condition(s): Cannabis Use Disorder, Mental Health Disorder, Physical Illness

Intervention(s): Regulated cannabis access in pharmacies

Status: Not yet recruiting

Enrollment (expected or actual): 370

Allocation: Randomized

Sponsor: Health Department of the Canton of Basel-Stadt

Principal Investigator: Marc Walter, Prof. Dr. med.

Completion Date (primary or actual): March 31, 2025

CT.gov Identifier: NCT05522205

The Stanford Tobacco Prevention Toolkit is a free, online Toolkit that consists of a curriculum, educational resources, and a resource directory to be used by educators, parents, juvenile justice workers, and healthcare providers to increase knowledge and awareness of cannabis and reduce use among youth. The aim of this study is to investigate the extent to which the curriculum changes students' intentions to use and actual use of cannabis.

First Posted: August 30, 2022

Condition(s): Cannabis Use

Intervention(s): Stanford Cannabis Awareness and Prevention curriculum

Status: Not yet recruiting

Enrollment (expected or actual): 600

Allocation: Randomized

Sponsor: Stanford University

Principal Investigator: Bonnie Halpern-Felsher, Marron and Mary Elizabeth Kendrick Professor in Pediatrics II

Completion Date (primary or actual): September 14, 2023

CT.gov Identifier: NCT05521321

A randomized, double blind, study of dronabinol as a palliative agent in the treatment of pain, inflammation, and other complications of sickle cell disease (SCD).

First Posted: August 29, 2022

Condition(s): Sickle Cell Disease

Intervention(s): Dronabinol, Placebo

Status: Recruiting

Enrollment (expected or actual): 60

Allocation: Randomized

Sponsor: Icahn School of Medicine at Mount Sinai

Principal Investigator: Susanna Curtis, Assistant Professor

Completion Date (primary or actual): September 2025

CT.gov Identifier: NCT05519111

The goal of this proposal is to determine how cannabinoid use affects the tumor immune microenvironment (TME) of melanoma by correlating TILs with reported cannabinoid use and circulating plasma cannabinoids. The central hypothesis is that cannabinoid use decreases TILs in melanoma in a dose-dependent fashion. This is important because cannabinoid-driven TME changes in melanoma may alter patient outcomes mediated by TILs and response to standard of care ICI treatments.

First Posted: August 29, 2022

Condition(s): Melanoma

Intervention(s): High-performance liquid chromatography-tandem mass spectrometry assays

Status: Recruiting

Enrollment (expected or actual): 90

Allocation:

Sponsor: University of Colorado, Denver

Principal Investigator:

Completion Date (primary or actual): August 31, 2024

CT.gov Identifier: NCT05520294

This study has the potential to contribute to a more complete understanding of the independent and combined effects of cannabis use and HIV on the brain and on inflammation. Such knowledge may inform future strategies for treating brain disease and inflammation. Participants will be randomly assigned to one of two groups, both of which will receive the same treatment in a different order over a period of about 6 weeks. The visits include physical examinations, blood tests, and other procedures designed to monitor subject safety and measure the effects of the study drug.

First Posted: August 25, 2022

Condition(s): HIV, Cannabis, THC, Neuroinflammatory Disease, Neuroinflammatory Response, Microbiome

Intervention(s): THC, CBD

Status: Not yet recruiting

Enrollment (expected or actual): 100

Allocation: Randomized

Sponsor: University of California, San Diego

Principal Investigator: Ronald Ellis, Principal Investigator

Completion Date (primary or actual): October 31, 2027

CT.gov Identifier: NCT05514899

This is a 20-week open-label study to evaluate the safety and efficacy of full-spectrum medicinal cannabis plant extract < 0.08% THC (FEN164) in children with Autism Spectrum Disorder.

First Posted: August 25, 2022

Condition(s): Autism Spectrum Disorder

Intervention(s): FEN164

Status: Active, not recruiting

Enrollment (expected or actual): 18

Allocation: N/A

Sponsor: Fenix Innovation Group

Principal Investigator:

Completion Date (primary or actual): September 1, 2022

CT.gov Identifier: NCT05516407

Malnutrition and inappropriate prescribing of renally excreted drugs are common among older persons and are associated with severe consequences such as complicated courses of treatment, mortality, and reduced quality of life. The overall purpose of CanPan is to optimize treatment of older persons with malnutrition with a focus on appetite stimulation and optimized prescribing of renal risk drugs. The CanPan trial consists of two sub-studies. Substudy 1 will provide knowledge on appetite and appetite stimulation and together, sub study 1 and 2 will offer unique knowledge on how body composition, renal function and biomarkers of organ function influence pharmacokinetics for a highly lipophilic (Sativex®) and hydrophilic (Hexamycin®) drug in older medical patients with malnutrition.

First Posted: August 16, 2022

Condition(s): Malnutrition, Anorexia, Cannabis, Aging, Emergency Service, Hospital, Renal Function, Pharmacokinetics

Intervention(s): Sativex

Status: Recruiting

Enrollment (expected or actual): 17

Allocation: Randomized

Sponsor: Ove Andersen

Principal Investigator: Ove Andersen, Research Director and Head of the Department of Clinical Research

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

CT.gov Identifier: NCT05503147

Aims: To characterize the pattern of cannabis and tobacco use and withdrawal symptoms in people who start treatment for cannabis use disorders (exclusive cannabis, concurrent and/or simultaneous with various tobacco products) through an aplication game and considering the type of users. Methodology: Mixed-methods research composed of three studies. Study I: qualitative participatory action study aimed at exploring the experiences and preferences of the cannabis users on the use of apps. This information will be instrumental in the co-design of the app. Study II: prospective longitudinal study aimed to establish consumption patterns and transitions between substances and to validate the scale of cannabis withdrawal symptoms in the Spanish population. Sample size: expected RR=1.20, α =0.05, β= 0.20, losses= 20% (n=282). Study III: qualitative study to explore participants' experiences during the process of quitting cannabis and / or tobacco. Expected results: Characterization and prediction of variables that influence cannabis and tobacco cessation/ reduction and describe withdrawal symptoms according to consumption patterns with aim of improving the design of future interventions.

First Posted: August 23, 2022

Condition(s): Cannabis Dependence, Tobacco Use, Withdrawal Syndrome, Substance Abuse

Intervention(s):

Status: Not yet recruiting

Enrollment (expected or actual): 282

Allocation:

Sponsor: Cristina Martínez Martínez

Principal Investigator: Cristina Martínez Martínez, Principal Investigator

Completion Date (primary or actual): December 2022

CT.gov Identifier: NCT05512091

The aim of the project is to assess the effectiveness of reducing the masseter muscles tension and hyperactivity in patients with a painful form of TMD by using polymers containing CBD compared to placebo polymers.

First Posted: October 3, 2022

Condition(s): Temporomandibular Disorder, Myofascial Pain, Orofacial Pain, CBD, Bruxism

Intervention(s): 5% polymer gel with CBD application, 10% polymer gel with CBD application, Placebo intervention

Status: Recruiting

Enrollment (expected or actual): 30

Allocation: Randomized

Sponsor: Medical University of Silesia

Principal Investigator:

Completion Date (primary or actual): January 30, 2023

CT.gov Identifier: NCT05562635

This study will be a randomized, double-blind, placebo-controlled, multicenter trial conducted to evaluate whether PP-01 mitigates the withdrawal symptoms associated with discontinuing cannabis in participants with moderate to severe Cannabis Use Disorder (CUD). The study will enroll approximately 225 participants with moderate to severe CUD and will include 5 arms, including a placebo arm, to help assess the incidence and severity of withdrawal symptoms in heavy long-term users of cannabis. Participants receive study medication for 34 days and participate in 11 visits (7 at a clinic and 4 telemedicine).

First Posted: August 10, 2022

Condition(s): Cannabis Withdrawal

Intervention(s): PP-01 High Dose, PP-01 Low Dose, Placebo, Nabilone, Gabapentin

Status: Recruiting

Enrollment (expected or actual): 225

Allocation: Randomized

Sponsor: PleoPharma, Inc.

Principal Investigator:

Completion Date (primary or actual): September 2023

CT.gov Identifier: NCT05494437

The suppression of chronic periodontitis after application of dental gel and toothpaste containing cannabidiol (CBD) will be evaluated.

First Posted: August 11, 2022

Condition(s): Chronic Periodontitis

Intervention(s): placebo dental gel, placebo toothpaste, Cannabidiol dental gel, Cannabidiol toothpaste, Placebo toothpaste, Corsodyl dental gel

Status: Completed

Enrollment (expected or actual): 90

Allocation: Randomized

Sponsor: Palacky University

Principal Investigator: Jan Vacek, Department of Dentistry, Olomouc University Hospital

Completion Date (primary or actual): January 27, 2022

CT.gov Identifier: NCT05498012

This study will examine the acute effects of cannabis on various aspects of memory. Eligible participants will complete a drug screen followed by baseline measures of cannabis consumption patterns, level of intoxication, euphoria, anxiety, stress, and verbal intelligence. Next, participants will be randomly assigned to inhale vapor from cannabis containing 20mg THC or placebo; both cannabis and placebo will be obtained from the National Institute on Drug Abuse (NIDA). Participants will complete a battery of memory tests including tests of prospective, verbal, visuospatial, autobiographical, source, verbal working, visuospatial working, false, and temporal order memory. Memory tests will be completed across two blocks in a counterbalanced order. Ratings of intoxication, euphoria, anxiety, and stress will be obtained three additional times after drug/placebo administration. The investigators hypothesize that participants who are randomly assigned to inhale cannabis vapor will perform worse on all memory tests than participants who inhale the placebo.

First Posted: August 4, 2022

Condition(s): Cannabis Use

Intervention(s): Cannabis, Placebo

Status: Not yet recruiting

Enrollment (expected or actual): 128

Allocation: Randomized

Sponsor: Washington State University

Principal Investigator:

Completion Date (primary or actual): January 1, 2025

CT.gov Identifier: NCT05488509

The information learned in these studies will help to inform doctors as to how to appropriately adjust doses of cannabidiol and tacrolimus in order to improve health outcomes and long-term treatment success for transplant recipients.

First Posted: August 5, 2022

Condition(s): CBD, Transplant Complication, Kidney Disease, Chronic

Intervention(s): Tacrolimus single dose, Epidiolex single dose, Epidiolex steady-state and tacrolimus single dose

Status: Recruiting

Enrollment (expected or actual): 72

Allocation: Non-Randomized

Sponsor: Indiana University

Principal Investigator: Michael Eadon, Associate Professor of Medicine

Completion Date (primary or actual): September 2027

CT.gov Identifier: NCT05490511

The primary goals of this study are to examine 1) marijuana modulation of oxycodone self-administration and 2) oxycodone modulation of marijuana self-administration, under controlled conditions and across a range of doses for each drug.

First Posted: August 2, 2022

Condition(s): Marijuana Use, Opioid Use

Intervention(s): Marijuana, Opioid

Status: Not yet recruiting

Enrollment (expected or actual): 12

Allocation: Randomized

Sponsor: Shanna Babalonis, PhD

Principal Investigator: Shanna Babalonis, PhD, Assistant Professor

Completion Date (primary or actual): August 2024

CT.gov Identifier: NCT05485012

The study will test a computerized treatment with subjects ages 13-17 years who are seeking treatment for alcohol and/or cannabis use. Youth will be recruited from the Center for Drug and Alcohol Programs (CDAP) Clinic in the Department of Psychiatry at MUSC. Follow-up assessments will be conducted at one- and three-months following treatment.

First Posted: August 3, 2022

Condition(s): Cannabis Use, Alcohol Use, Unspecified, Substance Use, Substance Use Disorders

Intervention(s): modified Approach-Avoidance Task (mAAT), which aims to modify automatic approach bias, modified Approach-Avoidance Task (mAAT) that does not aim to modify automatic approach bias.

Status: Recruiting

Enrollment (expected or actual): 52

Allocation: Randomized

Sponsor: Medical University of South Carolina

Principal Investigator: Austin Hahn, Assistant Professor

Completion Date (primary or actual): August 2025

CT.gov Identifier: NCT05486234

The main purpose of this study is to determine whether hippocampal synaptic vesicle density estimated by hippocampal [11C]APP-311/[11C]UCB-J binding in individuals diagnosed with cannabis use disorder (CUDs) improves with at least 4 weeks of confirmed abstinence from cannabis, in comparison to healthy controls (HCs). Furthermore, any change in synaptic vesicle density will be placed in functional context by measuring verbal memory, which is sensitive to hippocampal function, before and after at least 4 weeks of confirmed abstinence. Finally, the relationship between hippocampal [11C]UCB-J binding in CUDs with measures of cannabis exposure (e.g., age of initiation, cumulative lifetime dose) will be explored.

First Posted: July 25, 2022

Condition(s): Cannabis Use Disorder, Healthy

Intervention(s): [11C]APP311

Status: Recruiting

Enrollment (expected or actual): 42

Allocation: Non-Randomized

Sponsor: Yale University

Principal Investigator: Deepak C. D'Souza, Professor of Psychiatry

Completion Date (primary or actual): May 2027

CT.gov Identifier: NCT05472818

Preliminary data have suggested that cannabidiol (CBD) may have a number of clinical benefits, including anti-anxiety and antidepressant properties. This study is a pilot open-label clinical trial assessing a custom-formulated high-CBD product over the course of 4 weeks in patients with bipolar disorder who experience anxiety.

First Posted: July 14, 2022

Condition(s): Bipolar Disorder

Intervention(s): Cannabidiol

Status: Not yet recruiting

Enrollment (expected or actual): 25

Allocation: N/A

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): July 2024

CT.gov Identifier: NCT05457465

Cannabidiol, or CBD, is an over-the-counter "nutraceutical" that is more commonly being used by healthy adults for pain management, recovery from strenuous exercise, and general wellness. However, little research exists on the effects of CBD in otherwise healthy individuals. This study uses iontophoresis, a common technique used in physical therapy, to determine the effectiveness of topical CBD in lessening the reflex increased cutaneous vascular conductance response to stimulation of the skin.

First Posted: July 13, 2022

Condition(s): Effect of Drug

Intervention(s): Cannabidiol

Status: Not yet recruiting

Enrollment (expected or actual): 48

Allocation: Randomized

Sponsor: Penn State University

Principal Investigator: Lacy Alexander, Professor of Kinesiology

Completion Date (primary or actual): August 31, 2022

CT.gov Identifier: NCT05456113

Photorefractive Keratectomy (PRK) is a commonly performed corneal refractive surgery but has significant post-operative pain. Pain medications after PRK are typically opioid-acetaminophen combinations. Alternatives to opioid medication are worth consideration. Patients will receive PRK in each eye sequentially, using the CBD chemovar or codeine/acetaminophen for one eye and the other treatment for the fellow eye two weeks later.

First Posted: July 28, 2022

Condition(s): Photorefractive Keratectomy, Myopia, Hyperopia

Intervention(s): oral CBD, oral codeine/acetaminophen

Status: Not yet recruiting

Enrollment (expected or actual): 35

Allocation: Randomized

Sponsor: University of Florida

Principal Investigator:

Completion Date (primary or actual): March 2025

CT.gov Identifier: NCT05477875