Systematically Testing the Evidence on Marijuana

This is a double-blind, placebo-controlled, parallel group study designed to assess the tolerability and efficacy of fsCBD and bsCBD, compared to a placebo control, to reduce opioid use, anxiety, and pain and improve sleep and cognitive function. If eligible for the study, subjects will be randomized to receive one of the conditions for 12 weeks.

First Posted: March 29, 2022

Condition(s): Opioid Use Disorder

Intervention(s): Cannabidiol, Placebo

Status: Recruiting

Enrollment (expected or actual): 150

Allocation: Randomized

Sponsor: University of Colorado, Denver

Principal Investigator:

Completion Date (primary or actual): February 2027

CT.gov Identifier: NCT05299944

The current study will investigate the subjective, physiological, and cognitive performance effects of inhaled and orally ingested Delta-8 tetrahydrocannabinol (THC) in comparison to both placebo and Delta-9 THC. The purpose of this study is to assess the effects of Delta-8 THC as compared to placebo and Delta-9 THC. Oral fluid, urine, blood, and hair specimens will be collected from participants.

First Posted: March 18, 2022

Condition(s): Behavioral Pharmacology of Cannabis

Intervention(s): Oral Delta-8-THC Cannabis, Oral Delta-9-THC Cannabis, Oral Placebo, Vaporized Delta-8-THC Cannabis, Vaporized Delta-9-THC Cannabis, Vaporized Placebo

Status: Recruiting

Enrollment (expected or actual): 70

Allocation: Randomized

Sponsor: Johns Hopkins University

Principal Investigator:

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

CT.gov Identifier: NCT05287256

Fibromyalgia is considered a chronic pain syndrome, non-inflammatory, of unknown etiology, which manifests itself in the musculoskeletal system in up to 2.5% of the general population, predominantly in females, mainly between 35 and 44 years old, having a direct impact on the quality of life of their patients (JUNIOR; GOLDENFUM; SIENA, 2012; HEYMANN et al., 2017). In 1990, eighteen (18) specific sites were defined as tender points which are used to better diagnose fibromyalgia (WOLFE et al., 2010). Due to its clinical and exclusion diagnosis, treatment usually starts late, which allows the progression of symptoms and corroborates its low efficiency in the long term (DE SOUSA BRAZ et al., 2011). Due to the ineffective results and significant side effects that conventional treatment with drugs such as antidepressants, analgesics and anti-inflammatory drugs can provide, patients, physicians and researchers are looking for new main or adjuvant treatments, pharmacological and non-pharmacological (DE SOUSA BRAZ et al. al., 2011). In this context, it has been seen that the use of Cannabis sativa as a therapeutic option in fibromyalgia is promising, especially in reducing the pain caused by the disease and also the adjuvant symptoms, such as depression and sleep disorders (YASSIN; ORON; ROBINSON, 2019). This result must occur due to the action of cannabinoids, such as CBD and THC, on cannabinoid receptors distributed in peripheral nerves, spinal cord and supraspinal region, sites responsible for the reception, transmission and perception of pain (STE-MARIE et al., 2012). Currently, cannabinoids are considered safe analgesics with considerable efficacy, which demonstrates potential as a therapeutic option in the treatment of chronic pain, particularly in patients refractory to other treatments (HAUSER et al., 2018). In addition to its action on the painful mechanisms of fibromyalgia, the antidepressant effects of Cannabis are of great value in the treatment of fibromyalgia. These effects are explained by the modulation on serotonin 5-HT1A receptors, which has its effect exerted especially by CBD (ESPEJO-PORRAS et al., 2013). Considering that research has reported the effects of phytocannabinoids on the painful symptoms of fibromyalgia (HAUSER et al., 2018), the hypotheses of the present study are: Primary hypothesis: The dose-response curve and ED50 for the primary outcome, which is related to pain intensity, will be determined in the dose range between 0.1 and 10mg/day. The sensation of pain will be significantly reduced in participants receiving oral solution containing CBD/THC 10mg/day compared to those who will receive placebo. Secondary hypothesis: There will be a reduction in pain catastrophizing, as well as an improvement in the acceptance and action rate related to pain, a reduction in depression, an improvement in sleep latency and quality, a reduction in insomnia and an increase in the quality of life in patients treated with oral solution containing CBD/THC 10mg/day compared to those receiving placebo. Supporting Hypothesis: The tested CBD/THC solution will show efficacy and safety with no serious adverse effects.

First Posted: March 16, 2022

Condition(s): Fibromyalgia

Intervention(s): cannabidiol and tetrahydrocannabinol, Placebo

Status: Not yet recruiting

Enrollment (expected or actual): 40

Allocation: Randomized

Sponsor: FG Brasil LTDA

Principal Investigator:

Completion Date (primary or actual): August 20, 2022

CT.gov Identifier: NCT05283161

To examine the extent to which Cannabidiol (CBD) enhances fear conditioning extinction in college undergraduates who show elevated social anxiety. Undergraduates who display elevated social anxiety on standard assessments will be recruited at the University of Connecticut. All participants will be put in a standard fear conditioning paradigm where they are conditioned to fear a face that occasionally is followed by a shock to their wrist. The other face never is paired with a shock. After everybody learns this, half of the participants will receive 600 mg CBD Isolate Gel Capsules one time, and the other half will receive a placebo dose. Participants will then be presented with the faces with no shocks, and the rate and duration of extinction as measured by electrodermal response as well as subjective fear ratings via a visual analogue scale will be examined. It is hypothesized that participants that receive CBD will display enhanced extinction compared to the placebo group, as evidenced by reduced electrodermal response and reduced visual analogue fear ratings.

First Posted: March 17, 2022

Condition(s): Anxiety and Fear

Intervention(s): Cannabidiol Oral Product, Placebo

Status: Not yet recruiting

Enrollment (expected or actual): 160

Allocation: Randomized

Sponsor: University of Connecticut

Principal Investigator: Robert Astur, Associate Professor

Completion Date (primary or actual): December 2022

CT.gov Identifier: NCT05283382

While many empirical projects have described multiple potential health benefits of CBD, the potential for CBD to provide protection against the development of diabetes via favorable modification of the gut microbiota has received relatively less attention. We hope to learn if CBD can improve glucose tolerance and the gut microbiota, and if these two improvements might be related.

First Posted: March 17, 2022

Condition(s): Diabetes

Intervention(s): Cannabidiol (CBD) powder formulation, Matching Placebo Cannabidiol (CBD) powder formulation

Status: Active, not recruiting

Enrollment (expected or actual): 30

Allocation: Randomized

Sponsor: Christopher Bell

Principal Investigator: Christopher Bell, Associate Professor

Completion Date (primary or actual): March 9, 2023

CT.gov Identifier: NCT05285449

Subjects will participate in a 2-visit study protocol in which they will be administered cannabis of pre-determined concentrations and asked to complete a simulated drive in a driving simulator. Subjects will be scanned on two SpotLight-THC (Alpha and Beta iterations) devices and peripheral venous whole blood will be collected from subjects for analysis on up to four occasions on each visit. The purpose of the investigation will be to determine whether the SpotLight-THC device is a reliable measure of THC impairment at the roadside, with an objective to identify a unique blood analyte architecture for THC impairment using near infrared light and machine learning.

First Posted: March 11, 2022

Condition(s): Cannabis

Intervention(s): Cannabis(THC) inhaled

Status: Recruiting

Enrollment (expected or actual): 75

Allocation: Non-Randomized

Sponsor: ISBRG Corp

Principal Investigator:

Completion Date (primary or actual): August 2022

CT.gov Identifier: NCT05276232

The investigators are conducting a pilot (i.e. a small study) in order to find out the effectiveness and safety of medical cannabis in the management of chronic pain. At the end of this 3 month study, investigators will gather information on how easy it is for patients to enroll and complete the entire study. The results of this pilot study will help the study team design a larger randomized controlled trial.

First Posted: April 28, 2022

Condition(s): Chronic Pain, Opioid Use, Cannabis

Intervention(s): CBD oil ( MPL-001), CDB+THC oil (MPL-005), Placebo oil

Status: Recruiting

Enrollment (expected or actual): 51

Allocation: Randomized

Sponsor: University Health Network, Toronto

Principal Investigator: Jo Carroll, Research Manager

Completion Date (primary or actual): May 2024

CT.gov Identifier: NCT05351905

The overarching aim of this study is to examine the impact of acute cannabis and alcohol administration on driving performance, as well as identify methods for detecting driving under the influence of these substances. One-hundred twenty-five healthy volunteers will be randomized into one of 5 conditions; those who receive 1) low dose alcohol and placebo cannabis, 2) low dose alcohol and tetrahydrocannabinol (THC), 3) high dose alcohol and placebo cannabis, 4) placebo alcohol and THC, and 5) double placebo. Cannabis inhaled ad libitum and/or ingested alcohol will take place at the beginning of the day followed by the completion of driving simulations, components of the Drug Recognition Expert (DRE) evaluations, and bodily fluid draws (e.g., blood, oral fluid/saliva, breath) over the subsequent 4 hours after ingestion. The purpose of this study is to determine (1) the impact of Δ9-THC on driving performance with and without concurrent alcohol ingestion (2) the duration of driving impairment in terms of hours from initial use, (3) the relationship between performance on the DRE measures and cannabis/alcohol ingestion, and 4) if saliva or expired air can serve as a useful adjunct to the field for blood sampling.

First Posted: March 10, 2022

Condition(s): Driving Impaired, Alcohol Intoxication, Driving Under the Influence, Cannabis Intoxication

Intervention(s): Cannabis, Alcohol

Status: Not yet recruiting

Enrollment (expected or actual): 125

Allocation: Randomized

Sponsor: University of California, San Diego

Principal Investigator: Thomas D. Marcotte, PhD, Professor

Completion Date (primary or actual): June 2023

CT.gov Identifier: NCT05273658

Study based on the pharmacokinetic, pharmacodynamic, safety and stability evaluation of 3 standardized formulations of THC, to be used in healthy volunteers and post-chemotherapy patients as an adjuvant in the symptomatic treatment of the latter in discomfort associated with cancer treatment, with the aim of possible new therapeutic entities.

First Posted: March 10, 2022

Condition(s): Nausea Post Chemotherapy, Vomiting, Cancer Pain, Cancer Related Pain, Neoplasms

Intervention(s): Pharmacokinetic and pharmacodynamic profile of THC oral formulations with Dronabinol as comparator

Status: Not yet recruiting

Enrollment (expected or actual): 334

Allocation: Randomized

Sponsor: LaSanta S A S

Principal Investigator:

Completion Date (primary or actual): February 15, 2024

CT.gov Identifier: NCT05272865

The primary purpose of this study is to investigate the effect of guanfacine-ER on reductions in cannabis use and explore its effects on impulsivity and withdrawal through a hybrid in-person and virtual trial of treatment-seeking individuals with Cannabis Use Disorder (CUD), and assessing the feasibility of the virtual components of the study.

First Posted: March 10, 2022

Condition(s): Cannabis Use

Intervention(s): guanfacine-ER, Placebo

Status: Recruiting

Enrollment (expected or actual): 90

Allocation: Randomized

Sponsor: New York State Psychiatric Institute

Principal Investigator: Christina Ann Brezing, Assistant Professor of Psychiatry

Completion Date (primary or actual): March 2025

CT.gov Identifier: NCT05273567

The purpose of this research study is to compare the effects of cannabidiol (CBD), tetrahydrocannabinol (THC), or both, on sleep and pain in persons with multiple sclerosis (MS). Little is known about how CBD and/or THC may help sleep, reduce pain, or perhaps even treat pain through better sleep.

First Posted: March 8, 2022

Condition(s): Multiple Sclerosis, Sleep, Pain

Intervention(s): Cannabidiol (CBD), Tetrahydrocannabinol (THC), Placebo CBD, Placebo THC

Status: Recruiting

Enrollment (expected or actual): 166

Allocation: Randomized

Sponsor: Tiffany J. Braley, MD, MS

Principal Investigator: Tiffany J. Braley, MD, MS, Associate Professor of Neurology

Completion Date (primary or actual): June 2026

CT.gov Identifier: NCT05269628

Double-blind placebo controlled study of Cannabidiol (CBD) for symptoms of PTSD in adults using liquid structure(TM) Formulation (Nantheia ATL5(TM)). Subjects complete 3 weeks of baseline data collection including assessments of activity and sleep. Intervention is Nantheia ATL5 or placebo. Dose is initiated at 400mg BID and maintained over 8 weeks. Standardized symptom profile measurements, clinician assessments, laboratory testing, collection of inflammatory biomarkers, and suicide screening is completed throughout. Age- and gender-matched comparison subjects are enrolled and complete baseline data collection only. All subjects may complete optional procedures of driving assessments and functional MRI (fMRI).

First Posted: March 8, 2022

Condition(s): PTSD

Intervention(s): Cannabidiol (CBD) as Nantheia ATL5, Placebo

Status: Recruiting

Enrollment (expected or actual): 180

Allocation: Randomized

Sponsor: University of Nebraska

Principal Investigator: Matthew Rizzo, Professor

Completion Date (primary or actual): May 2027

CT.gov Identifier: NCT05269459

The goal of the current study is to evaluate the bioavaibiltiy of CBD in normal healthy Individuals. This is an open cross-over design study in healthy individuals to assess the safety and pharmacokinetic (PK) effects of cannabidiol.

First Posted: March 8, 2022

Condition(s): Healthy

Intervention(s): Cannabidiol, Cannabidiol, Epidiolex, Cannabidiol

Status: Active, not recruiting

Enrollment (expected or actual): 24

Allocation: Non-Randomized

Sponsor: Hurd,Yasmin, Ph.D.

Principal Investigator:

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

CT.gov Identifier: NCT05269706

Innovative treatments are urgently needed for severe behavioural problems (SBPs) in adults with intellectual and developmental disabilities (IDD). Although a synthetic cannabinoid, nabilone may be a plausible and safe alternative to treat SBP, safety and efficacy of nabilone in people with IDD has never been evaluated. The investigators propose to conduct this first-ever Phase I pre-pilot open-label clinical trial to collect data on the tolerability and safety profile of nabilone in adults with IDD, and explore changes in SBP pre- and post-treatment. The results will inform a next-stage pilot randomized controlled trial, followed by a fully powered trial eventually.

First Posted: March 10, 2022

Condition(s): Intellectual Disability, Developmental Disability, Aggression, Behavior Problem

Intervention(s): Nabilone

Status: Recruiting

Enrollment (expected or actual): 30

Allocation: N/A

Sponsor: Hsiang-Yuan Lin

Principal Investigator: Hsiang-Yuan Lin, Clinician-Scientist

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

CT.gov Identifier: NCT05273320

The purpose of this Phase I non-therapeutic trial is to examine the neurological effects of cannabis on stress reactivity and inhibition in healthy cannabis and heavy alcohol co-users. We expect differences between high ratio CBD:THC cannabis oil, low ratio CBD:THC cannabis oil, and/or placebo on outcome measures.

First Posted: March 2, 2022

Condition(s): Healthy

Intervention(s): Cannabis oil with a high ratio of THC to CBD, Cannabis oil with a high ratio of CBD to THC, Placebo

Status: Not yet recruiting

Enrollment (expected or actual): 12

Allocation: Randomized

Sponsor: University of British Columbia

Principal Investigator: Christian Schutz, Associate Professor

Completion Date (primary or actual): December 2024

CT.gov Identifier: NCT05261321

This is a prospective, observational study on approximately 70 Real World participants affected by LGS or DS, treated with Epidyolex® as prescribed in the summary of product characteristics. The eligible participants are expected to participate in the study for a duration of 56 weeks of treatment.

First Posted: August 3, 2022

Condition(s): Lennox Gastaut Syndrome, Dravet Syndrome

Intervention(s): Epidiolex 100 mg/mL Oral Solution

Status: Not yet recruiting

Enrollment (expected or actual): 70

Allocation:

Sponsor: Jazz Pharmaceuticals

Principal Investigator:

Completion Date (primary or actual): October 2023

CT.gov Identifier: NCT05485831

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: 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, 2025

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: Suspended

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 2024

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: Terminated

Enrollment (expected or actual): 8

Allocation: Randomized

Sponsor: Brlev Agricultural Crops Ltd

Principal Investigator:

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

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

The purpose of this proof-of-concept study is to evaluate the safety, feasibility and acceptability of a breathwork workshop intervention in individuals with cannabis use disorder.

First Posted: February 2, 2022

Condition(s): Addiction, Substance Abuse, Cannabis Use Disorder, Cannabis Use, Cannabis Dependence, Cannabis Abuse

Intervention(s): Breathwork workshop

Status: Recruiting

Enrollment (expected or actual): 10

Allocation: N/A

Sponsor: Elias Dakwar

Principal Investigator: Elias Dakwar, Associate Professor of Clinical Psychiatry

Completion Date (primary or actual): August 2023

CT.gov Identifier: NCT05219825

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): January 31, 2023

CT.gov Identifier: NCT05244460