Systematically Testing the Evidence on Marijuana

This study is a prospective, randomized, nonblinded trial to evaluate the effectiveness of Cannabidiol (CBD) oil on post-operative pain control compared to opioid medications.

First Posted: February 15, 2022

Condition(s): Post-operative Pain

Intervention(s): Cannabidiol Oil

Status: Not yet recruiting

Enrollment (expected or actual): 50

Allocation: Randomized

Sponsor: Foundation for Orthopaedic Research and Education

Principal Investigator: Michael C. Doarn, Principal Investigator, Clinical Professor of Orthopaedic Surgery - USF

Completion Date (primary or actual): February 15, 2023

CT.gov Identifier: NCT05240755

Rationale: Opioid misuse and abuse are common problems in the Western world. The rate of unintentional drug overdose is rapidly increasing, not only in the Unites States but also in the Netherlands. Additionally, it is well known that opioids are often used (and abused) in combination with other legal or illicit substances, for example cannabis, including medicinal (i.e. doctor prescribed) cannabis. A major opioid-induced adverse effect is respiratory depression and there are no data that show how oxycodone interacts with cannabis on the ventilatory control system. An appreciable effect is possible given the sedative effects of cannabis. Moreover, investigators previously showed that combining even a low dose of oxycodone (20 mg) with ethanol increased the likelihood of an apneic event (van der Schrier et al. Anesthesiology 2017; 102: 115-122). Because of this side effect and also due to the rising number of addicted chronic opioid users, there is an increasing imminent societal, political and medical interest in advancing research on opioids, opioid-drug interaction and alternatives for the treatment of various chronic illnesses and chronic pain. Hypothesis: The investigators hypothesize that cannabis will amplify the ventilatory depressant effect of oxycodone (primary end-point). Objective: The objective of the study is to quantify the interactive effect of Δ9-tetrahydrocannabinol (THC) and oxycodone on ventilatory control. Study design: Double blind, randomized cross-over, placebo-controlled design. Study population: Healthy human volunteers between the age of 18 and 45 years old. Intervention: Visit A: placebo capsule at t = 0 min + Bedrocan (22.4 mg THC) at t = 90 and 270 min; Visit B: oxycodone 20 mg at t = 0 min + Bedrocan (22.4 mg THC) at t = 90 and 270 min. Main study parameters/endpoints: Primary endpoint: The effect of inhaled THC on ventilation at an end-tidal PCO2 = 55 mmHg without and with concomitant intake of 20 mg oxycodone immediate release (IR) capsule in healthy volunteers 120 min after oxycodone intake. Secondary endpoints: (1) Outcome of Bowdle and Bond & Lader questionnaires; (2) Level of sedation; (3) Pain Pressure Threshold; (4) slope of the hypercapnic ventilatory response; (5) plasma concentrations of THC, 11-OH-THC and oxycodone; a secondary analysis will be performed on the pharmacokinetic and pharmacodynamic data (PKPD modeling).

First Posted: February 11, 2022

Condition(s): Respiratory Depression, Cannabis Use, Opioid Use

Intervention(s): Medicinal cannabis in combination with oxycodon, Medicinal cannabis in combination with placebo oxycodon

Status: Recruiting

Enrollment (expected or actual): 20

Allocation: Randomized

Sponsor: Leiden University Medical Center

Principal Investigator: Albert Dahan, Coordinating investigator

Completion Date (primary or actual): December 2022

CT.gov Identifier: NCT05235503

Insomnia is a disorder in which people have inadequate or poor-quality sleep due to a number of factors, such as difficulty falling asleep, waking up frequently during the night with difficulty returning to sleep, waking up too early in the morning, or having unrefreshing sleep. Defined CBD is a capsule composed of highly purified (>99.9%) hemp-derived cannabidiol (CBD) and terpenes produced as a potential sleep aid for people with insomnia. This product contains no detectable Delta-9-tetrahydrocannabinol (Delta-9-THC). This trial is specifically designed to evaluate the efficacy of Defined CBD on sleep physiology in people with insomnia.

First Posted: February 10, 2022

Condition(s): Insomnia

Intervention(s): Defined CBD, Placebo

Status: Active, not recruiting

Enrollment (expected or actual): 125

Allocation: Randomized

Sponsor: Defined Research

Principal Investigator:

Completion Date (primary or actual): July 2, 2022

CT.gov Identifier: NCT05233761

To identify the autonomic effects of recreationally-relevant doses of cannabidiol (CBD) in an older population, and to evaluate the effect of CBD on exercise performance and recovery.

First Posted: February 9, 2022

Condition(s): Healthy

Intervention(s): Placebo, Cannabidiol

Status: Not yet recruiting

Enrollment (expected or actual): 60

Allocation: Randomized

Sponsor: Castleton University

Principal Investigator: Andrea Corcoran, Assistant Professor of Exercise Science

Completion Date (primary or actual): December 2023

CT.gov Identifier: NCT05232123

ADHD is the most frequent neuro-developmental disorder in childhood and often continues into adolescence and adulthood. Indicated drug treatments for ADHD fall into 2 categories: stimulants (such as methylphenidate and amphetamines) and non-stimulants (such as atomoxetine, guanfacine and clonidine) but some persons cannot tolerate their secondary effects or find them non-effective. In the last decade, medical cannabis products have been researched as possible treatment for neurological and mental diseases such as: Post trauma disorder (PTD), autism (ASD), epilepsy, fibromyalgia (FM) and more. Data on the effects of cannabidiol rich cannabis extract use for ADHD seems promising but is still limited. The aim of this study is to investigate if oral cannabinoids given to adults with ADHD affect the symptoms of the disorder. The main objectives of the study are: 1) to characterize the effects of treatment with cannabis oil on symptoms of ADHD; 2) to compare safety and efficacy of cannabis oil products with different CBD,Cannabidivarin (CBDV), cannabigerol (CBG) and THC ratio; 3) and to measure endocannabinoids, THC and CBD and metabolites levels in the blood of the participants. In this study, participants diagnosed with ADHD will be treated with canabidiol-rich cannabis oil and will follow up weekly during approx.1 month (the study period). Blood tests will be performed before and after treatment. Blood tests include blood count, blood chemistry, hormones profile, phyto- and endo- cannabinoids and their metabolites. Test of Variables of Attention test (TOVA) will be administrated before and after treatment

First Posted: February 2, 2022

Condition(s): ADHD, Hyperactivity, Attention Deficit

Intervention(s): Cannabis oil

Status: Recruiting

Enrollment (expected or actual): 244

Allocation: Randomized

Sponsor: Brlev Agricultural Crops Ltd

Principal Investigator:

Completion Date (primary or actual): July 2023

CT.gov Identifier: NCT05219370

Children with autism spectrum disorder (ASD) commonly exhibit comorbid symptoms such as aggression, hyperactivity and anxiety. Data on the effects of cannabidiol rich cannabis extract use for ASD is promising but still limited. The aim of this study is to investigate if oral cannabinoids treatment to children and young adults with ASD affect the comorbidities of autism, including sleep and eating problems, anxiety and violence. The main objectives of the study are: 1) to characterize the effect of treatment with cannabis oil on comorbid symptoms of ASD; 2) to compare safety and efficacy of different cannabis products with identical CBD:THC ratio; 3) to investigate the effect of treatment on cognitive and adaptive behavior; and 4) to measure THC and CBD and metabolites levels in the blood of the patients. In this study, patients diagnosed with ASD will be treated with cannabidiol-rich cannabis oil (CBD:THC ratio of 20:1). The researchers will collect parental reports on ASD comorbid symptoms before and bi-weekly during 6 months of the study period. Blood tests will be performed before and after three months of treatment. Blood tests include blood count, blood chemistry, hormones profile, phyto- and endo- cannabinoids and metabolites. Cognitive evaluation will be done before and after six months of treatment. Electroencephalogram (EEG) to exclude epilepsy will be performed before and after six months of treatment.

First Posted: January 28, 2022

Condition(s): Autism Spectrum Disorder

Intervention(s): Cannabis oil

Status: Active, not recruiting

Enrollment (expected or actual): 128

Allocation: Randomized

Sponsor: Assaf-Harofeh Medical Center

Principal Investigator:

Completion Date (primary or actual): December 31, 2021

CT.gov Identifier: NCT05212493

Despite many pharmaceutical options, there are no optimal treatments for Chronic musculoskeletal pain (CMP). Although many Canadians use medical cannabis (MC; legally authorized) to relieve their pain, there are no firm conclusions on the efficacy and safety of MC against CMP. In order to increase knowledge on this topic, it is essential to describe the current use of MC against CMP by Canadians and to understand patients' and physicians' perceptions and attitudes. Objectives: This study will evaluate the use of MC against CMP among adults and aims at: 1-Describing the use of MC in Canada, and the main characteristics of users and prescribers; 2-Identifying the therapeutic and adverse effects of MC from the users' perspective; 3a- Identifying the psychosocial, organizational, socio-demographic and health-related factors that influence the use and prescription of MC; and 3b- Quantifying the impacts of these factors on the use and prescription of MC in the management of CMP. Methods: 1) We will analyse available data on the users and prescribers of MC from Health Canada and from the Registre Cannabis Québec; 2) We will use mixed methods to collect data from patients affected by CMP and their physicians. Data from Health Canada will allow to document the prevalence and recent evolution of MC use. The qualitative phase of the second part of the study will identify obstacles and facilitators for the use AND for the prescribing of MC against CMP, including the need for more information in patients suffering from CMP and in physicians. Reasoned samples of patients and physicians will be recruited; information will then be collected by semi-structured interviews. For the quantitative phase, a pan-Canadian survey will be conducted, using a questionnaire built with the results of the qualitative phase of the study. The proposed study will describe the current use of MC against CMP in Canada and will allow to better understand the motivations and expectations of physicians and patients.

First Posted: January 27, 2022

Condition(s): Musculoskeletal Pain, Cannabis Use

Intervention(s):

Status: Recruiting

Enrollment (expected or actual): 45

Allocation:

Sponsor: CHU de Quebec-Universite Laval

Principal Investigator: Dre Edeltraut Kröger, Research Scientist, Centre intégré universitaire de santé et de services sociaux de la Capitale-Nationale

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

CT.gov Identifier: NCT05210660

The purpose of this study is to assess the efficacy of droperidol as a treatment of cannabinoid hyperemesis syndrome.

First Posted: February 17, 2022

Condition(s): Cannabis Hyperemesis Syndrome

Intervention(s): Droperidol Injectable Product, Diphenhydramine

Status: Recruiting

Enrollment (expected or actual): 45

Allocation: N/A

Sponsor: Mercy Health Ohio

Principal Investigator:

Completion Date (primary or actual): December 2, 2022

CT.gov Identifier: NCT05244460

People living with HIV (PLWH) are affected by comorbidities appearing to be strongly related to chronic inflammation, a condition characterizing PLWH. The investigators propose to study the effects of CBD on inflammation in PLWH, and establish the molecular role of different immune cells in this process. The investigators plan to use single cell RNA-sequencing (scRNAseq) to isolate CBD-specific cellular phenotypes from five persons with HIV who will provide blood samples before and after taking CBD.

First Posted: January 27, 2022

Condition(s): Chronic Inflammation

Intervention(s): CBD oil

Status: Recruiting

Enrollment (expected or actual): 7

Allocation: N/A

Sponsor: University of Florida

Principal Investigator:

Completion Date (primary or actual): February 2024

CT.gov Identifier: NCT05209867

Lots of people, including athletes and people who like to exercise regularly, enjoy marijuana. Some people believe marijuana might improve their ability to exercise. There are no recent, up-to-date scientific studies to suggest that this belief is right or wrong. The goal of this study is to determine the influence of marijuana on exercise performance.

First Posted: January 14, 2022

Condition(s): Endurance Exercise

Intervention(s): THC 5, Placebo

Status: Active, not recruiting

Enrollment (expected or actual): 11

Allocation: Randomized

Sponsor: Christopher Bell

Principal Investigator: Christopher Bell, Associate Professor

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

CT.gov Identifier: NCT05192239

Investigators will gather data on both the beneficial and harmful effects of edible cannabis of varying composition (THC-only vs. CBD-only vs. THC+CBD), and will examine the process by which older adult cannabis users decide what type of cannabis product is preferred.

First Posted: January 12, 2022

Condition(s): Cannabis Use

Intervention(s): Choice of cannabis product

Status: Recruiting

Enrollment (expected or actual): 350

Allocation:

Sponsor: University of Colorado, Boulder

Principal Investigator: Angela Bryan, Professor

Completion Date (primary or actual): January 31, 2026

CT.gov Identifier: NCT05188404

This is a single site, pilot double-blind, randomized, placebo-controlled, cross-over study of 10 participants comparing medicinal cannabis (THC:CBD 10:15 oil) with placebo in reducing tics in adolescents aged 12 - 18 years with severe Tourette Syndrome (TS). The primary objective of this pilot study is to evaluate all elements of the study design (recruitment strategy, study duration, study procedures, study medication tolerance and outcome measures) to assess if they are acceptable and feasible for the conduct of a full-scale randomized controlled trial of THC:CBD 10:15 oil to reduce tic severity in adolescents with TS. The secondary objective of this study is to collect preliminary data on the safety of oral THC:CBD 10:15 oil in adolescents aged 12 to 18 years with TS. As an exploratory aim data from clinician- and parent-rated measures will be compared across the phases to explore for a signal of efficacy on primary (tic reduction) and secondary (premonitory urges, obsessive compulsive behaviors, Attention Deficit Hyperactivity Disorder [ADHD] symptoms) outcome measures.

First Posted: January 11, 2022

Condition(s): Tourette Syndrome in Adolescence

Intervention(s): Medicinal cannabis (MC): THC 10mg/mL : CBD 15mg/mL, manufactured by Cann Group Ltd., Placebo

Status: Recruiting

Enrollment (expected or actual): 10

Allocation: Randomized

Sponsor: Murdoch Childrens Research Institute

Principal Investigator:

Completion Date (primary or actual): May 2023

CT.gov Identifier: NCT05184478

Cannabidiol (CBD), a non-psychoactive hemp derivative, is an attractive therapeutic target, and is most supported by the scientific community as an antiepileptic, anxiolytic, and antipsychotic. Additionally, CBD may cause alterations in aspects of health and fitness, fatigue, stress, calmness, quality of life, cognitive function, ability to maintain focus, sleep quantity, and sleep quality. Cannabidiol may be associated with alterations in inflammatory response in the human body, which has implications in both healthy and diseased populations. Natural killers cells (NKC) play a vital role in maintain your body's defenses and are an essential component of your immune system. In humans, NKC contain the highest concentrations of receptors associated with the endocannabinoid system and CBD. Human models have demonstrated that CBD use increases the percentage of NKC in peripheral blood. However, similar models found that CBD administration inhibits markers of NKC cytotoxic function, a beneficial cellular mechanism used to prevent malignant cell transformation and viral infection. The overarching goal of this investigation is to determine the effects of an 8-week CBD intervention on measures of fatigue, stress, calmness, quality of life, cognitive function, focus, health and fitness, and sleep quantity, and sleep quality. In addition, this study will explore a potential CBD mechanism of action with a focus on biomarkers of neural health, inflammation, liver health, kidney health, as well as NKC number and function.

First Posted: January 12, 2022

Condition(s): Healthy

Intervention(s): Daily Beverage Intervention

Status: Recruiting

Enrollment (expected or actual): 100

Allocation: Randomized

Sponsor: University of Northern Colorado

Principal Investigator: Laura Stewart, Professor

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

CT.gov Identifier: NCT05189275

This study will recruit healthy volunteers who use cannabis infrequently. Each participant will attend the laboratory on five occasions: an initial visit to check that they are safe to join the study and four days of testing. Participants will be administered, in a randomized order, vaporized cannabis containing one of four different ratios of CBD:THC (0:1, 1:1, 2:1, 3:1). The cannabis administration will follow a standardised inhalation procedure using a medical-grade vaporizer device. Participants will complete a series of tasks measuring cognition, psychosis, anxiety and other subjective experiences. The study will be carried out at the NIHR-Wellcome Trust Clinical Research Facility at King's College Hospital.

First Posted: December 27, 2021

Condition(s): Cannabis Use

Intervention(s): THC, Cannabidiol, Cannabidiol, Cannabidiol

Status: Completed

Enrollment (expected or actual): 46

Allocation: Randomized

Sponsor: King's College London

Principal Investigator:

Completion Date (primary or actual): June 9, 2019

CT.gov Identifier: NCT05170217

This is a Phase 3 open-label extension (OLE) study in patients diagnosed with Prader-Willi Syndrome (PWS) who completed the Maintenance Period of the randomized, placebo-controlled Phase 2/3 study SCOUT-015. The primary objective of this study is to assess the long-term safety and tolerability of RAD011.

First Posted: May 24, 2022

Condition(s): Prader-Willi Syndrome

Intervention(s): RAD011

Status: Not yet recruiting

Enrollment (expected or actual): 200

Allocation: N/A

Sponsor: Radius Pharmaceuticals, Inc.

Principal Investigator:

Completion Date (primary or actual): August 2025

CT.gov Identifier: NCT05387798

This study will test whether 42 days of cannabis abstinence, compared to continued cannabis use, is associated with improvements in cognition and psychiatric disorder symptoms. Identical twins, who are concordant on cannabis use, will be experimentally-manipulated to be discordant for 42 days. Each twin, within a twin pair, will be randomly assigned to either the contingency management condition, incentive-based protocol to promote cannabis abstinence, or control condition, no changes in cannabis use requested.

First Posted: December 16, 2021

Condition(s): Cannabis

Intervention(s): Contingency management

Status: Not yet recruiting

Enrollment (expected or actual): 100

Allocation: Randomized

Sponsor: University of Colorado, Denver

Principal Investigator:

Completion Date (primary or actual): February 1, 2026

CT.gov Identifier: NCT05160688

The non-psychotomimetic cannabis compound cannabidiol (CBD) has been found effective for reducing alcohol drinking in mice. Moreover, other experimental studies have found that CBD reduced alcohol-induced steatosis in the liver, and reduced alcohol-related injury in the brain. Despite these promising results from animal data, no human study has been conducted yet in alcohol use disorder (AUD).

First Posted: December 16, 2021

Condition(s): Alcohol Use Disorder

Intervention(s): Cannabidiol Cap/Tab, Placebo Cap/Tab

Status: Not yet recruiting

Enrollment (expected or actual): 76

Allocation: Randomized

Sponsor: Hôpital le Vinatier

Principal Investigator:

Completion Date (primary or actual): September 30, 2024

CT.gov Identifier: NCT05159830

This will be a 12-week randomized trial. Outpatients and patients from the Mood and Anxiety program at the Centre for Addiction and Mental Health (CAMH) with a current diagnosis of post-traumatic stressed disorder (PTSD) and cannabis-use disorder (CUD) will be randomized to receive individual motivational interviewing therapy and contingency management (n = 12) or individual motivational interviewing therapy alone (control group, n = 12) after enrolment.

First Posted: December 17, 2021

Condition(s): PTSD, Cannabis Use, Cognitive Symptom, Comorbidities and Coexisting Conditions

Intervention(s): Contingency-management, Enhanced usual care

Status: Recruiting

Enrollment (expected or actual): 24

Allocation: Randomized

Sponsor: Centre for Addiction and Mental Health

Principal Investigator: Ahmed N Hassan, Doctor

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

CT.gov Identifier: NCT05162651

The primary goal of this pilot project is to demonstrate the safety and feasibility of using Cannabidiol (CBD) in combination with standard of care prolonged exposure (PE) psychotherapy to reduce PTSD symptoms.

First Posted: November 24, 2021

Condition(s): Posttraumatic Stress Disorder, Stress Disorders, Post-Traumatic

Intervention(s): Cannabidiol (CBD) oral solution, Placebo, Massed Prolonged Exposure (mPE)

Status: Recruiting

Enrollment (expected or actual): 28

Allocation: Randomized

Sponsor: The University of Texas Health Science Center at San Antonio

Principal Investigator: Casey Straud, Assistant Professor

Completion Date (primary or actual): January 2023

CT.gov Identifier: NCT05132699

The bioavailability of cannabinoids differs greatly for different routes of administration. When applied topically to the skin, they are absorbed through the skin or hair follicles while interacting with receptors to provide localized effects. To gain more information on the potential of this route of administration in therapeutic applications, this open-label study will investigate the skin absorption and bioavailability of CBD and THC delivered trans-dermally.

First Posted: November 16, 2021

Condition(s): Biological Availability, Skin Absorption, CBD, THC

Intervention(s): CBD and THC with GT4 technology

Status: Completed

Enrollment (expected or actual): 18

Allocation: N/A

Sponsor: Gefion Canada Inc.

Principal Investigator:

Completion Date (primary or actual): January 18, 2022

CT.gov Identifier: NCT05121506

Tetrahydrocannabidiol (THC) is the psychoactive chemical in cannabis that makes people high. This study aims to dissect acute impairment of various forms of memory and learning by THC in cannabis compared to placebo. Impairment will be assessed via a short cognitive test battery and then subjects will complete four tasks in the fMRI scanner.

First Posted: November 11, 2021

Condition(s): Marijuana, THC, Cannabis

Intervention(s): Marijuana, Hash, THC, or Grass, Placebo

Status: Recruiting

Enrollment (expected or actual): 20

Allocation: Randomized

Sponsor: Hartford Hospital

Principal Investigator: Godfrey Pearlson, Founding Director Olin Neuropsychiatry Research Center; Professor Yale University

Completion Date (primary or actual): February 2024

CT.gov Identifier: NCT05116527

The purpose of this study is to analyze drug-drug interactions of CBD on co-administered Morphine as first step in understanding CBD-opioid interactions.

First Posted: December 3, 2021

Condition(s): Opioid Use Disorder

Intervention(s): Morphine Sulfate

Status: Recruiting

Enrollment (expected or actual): 60

Allocation: Non-Randomized

Sponsor: National Institute on Drug Abuse (NIDA)

Principal Investigator:

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

CT.gov Identifier: NCT05143424

This Phase II STTR program consists of two major goals within the overarching goal of developing and validating a proprietary device (BID2) for marijuana and opioid detection in breath samples.

First Posted: May 20, 2022

Condition(s): Opiate Abuse, Marijuana Abuse

Intervention(s): Marihuana, BID2 Instrument - breathalyzer

Status: Recruiting

Enrollment (expected or actual): 50

Allocation: N/A

Sponsor: Mclean Hospital

Principal Investigator: Scott Lukas, Director, McLean Imaging Center and BPRL

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

CT.gov Identifier: NCT05384470

This research responds to NHTSA's request with a proposal to increase our understanding of smoked cannabis' (CNB's) acute effects on driving-relevant cognition and simulated driving performance, the persistence of these deficits over the hours after use, and the influence of prior experience with CNB on these effects. This extension study will aim to further investigate marijuana impaired behavior, using a similar design to our previous NHTSA Examine the Feasibility of a Standardized Field Test for Marijuana Impairment and the prior NIDA Neuroscience of Marijuana-Impaired Driving award, that used similar techniques and measures to quantify marijuana impaired automobile driving. We will be utilizing tasks and assessments that were shown to be strong indicators for cognitive and driving impairment in our NHTSA study.

First Posted: November 10, 2021

Condition(s): Marijuana Impairment

Intervention(s): Medium THC, Placebo THC

Status: Recruiting

Enrollment (expected or actual): 32

Allocation: Non-Randomized

Sponsor: Yale University

Principal Investigator: Godfrey Pearlson, Professor of Psychiatry and Neuroscience, Founding Director Olin Neuropsychiatry Research Center

Completion Date (primary or actual): February 2024

CT.gov Identifier: NCT05115513

Medical cannabis (MC) is a standard treatment in Israel to adults with resistant Gilles de la Tourette syndrome (GTS). While small randomized control trials assessed THC efficacy on tics and premonitory urge, only small retrospective studies assessed MC efficacy and tolerability in GTS. Herein, By using an open-label, prospective design, our aim is to determine the preferred method of use, efficacy and tolerability of 12 weeks of treatment with MC in adult patients with GTS.

First Posted: November 10, 2021

Condition(s): Tourette Syndrome, Cannabis

Intervention(s): Medical Cannabis

Status: Completed

Enrollment (expected or actual): 18

Allocation:

Sponsor: Tel-Aviv Sourasky Medical Center

Principal Investigator:

Completion Date (primary or actual): March 31, 2021

CT.gov Identifier: NCT05115318