Systematically Testing the Evidence on Marijuana

Alcohol and Cannabis (CNB) are two of the most widely used intoxicants. The effects of driving while intoxicated on alcohol are well documented, resulting in numerous drunken driving laws and regulations. As CNB begins to be decriminalized, medical CNB use allowed in multiple U.S. states, and perception of harmfulness falls, CNB use is predicted to rise and it will become increasingly common to publicly encounter persons who recently used the drug. An area of potentially high concern is if ever-greater numbers of CNB users and its legalization will increase the risk of driving while intoxicated from recent CNB use, thereby increasing the risks to public safety. This study aims to examine the combined effects of smoking marijuana and drinking alcohol on simulated driving.

First Posted: April 23, 2021

Condition(s): Marijuana Impairment, Alcohol Impairment

Intervention(s): Low Marijuana, Hash, THC, or Grass, High Marijuana, Hash, THC, or Grass, Placebo, 0.05 BAC Alcohol, 0.08 BAC Alcohol

Status: Recruiting

Enrollment (expected or actual): 12

Allocation: Randomized

Sponsor: Yale University

Principal Investigator: Godfrey Pearlson, Principal Investigator

Completion Date (primary or actual): April 2023

CT.gov Identifier: NCT04856566

Memory deficits are one of the most consistently observed cognitive effects of marijuana use. There is evidence that some decrements attributable to the primary psychoactive ingredient, delta-9-tetrahydrocannabinol (THC), may be attenuated by cannabidiol (CBD). This study will help us learn more about the relationship between THC and CBD consumption with memory processes. A combination of MRI and neuropsychological tests (which are computer and paper/pencil tasks) will be used to measure the neurocognitive and behavioral impacts of THC and CBD use.

First Posted: April 22, 2021

Condition(s): Marijuana Use, Cannabis Use, Cannabis Intoxication

Intervention(s): High THC/No CBD Marihuana, High THC/High CBD Marihuana, No THC/No CBD Marihuana

Status: Not yet recruiting

Enrollment (expected or actual): 9

Allocation: Randomized

Sponsor: Hartford Hospital

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

Completion Date (primary or actual): June 30, 2022

CT.gov Identifier: NCT04855526

This study will assess the analgesic, appetite-stimulating, and subjective effects of cannabigerol (CBG) alone and in combination with THC.

First Posted: April 26, 2021

Condition(s): Pain, Appetite Loss, Abuse, Drug

Intervention(s): Placebo, Low CBG, High CBG, Low THC, High THC

Status: Not yet recruiting

Enrollment (expected or actual): 20

Allocation: Randomized

Sponsor: University of California, Los Angeles

Principal Investigator: Ziva D. Cooper, PhD, Associate Professor

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

CT.gov Identifier: NCT04859296

This study will examine how medical cannabis use affects neuropathic pain, inflammation and adverse events in people living with HIV (PLWH) with neuropathic pain. We will study the effect of medical cannabis with different THC.CBD content on neuropathic pain, inflammation and adverse events.

First Posted: April 26, 2021

Condition(s): HIV Infections, Neuropathic Pain, Cannabis

Intervention(s):

Status: Not yet recruiting

Enrollment (expected or actual): 100

Allocation:

Sponsor: Montefiore Medical Center

Principal Investigator: Deepika Slawek, Assistant Professor of Medicine

Completion Date (primary or actual): December 12, 2022

CT.gov Identifier: NCT04860089

The acute effects of cannabis may differ between adolescents and adults. Furthermore, these effects may be tempered by the presence of cannabidiol. This double-blind, placebo-controlled, crossover experiment investigates the acute effects of cannabis (with and without cannabidiol) on subjective effects, behavioural responses and neural functioning in 16-17 year-olds and 26-29 year-olds who regularly use cannabis (0.5-3 days per week).

First Posted: April 20, 2021

Condition(s): Cannabis, Cannabis Intoxication, Cannabis Use, Cannabis Dependence, Marijuana, THC, CBD, Adolescent Development

Intervention(s): Cannabis with delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), Cannabis with THC without CBD, Placebo cannabis

Status: Completed

Enrollment (expected or actual): 48

Allocation: Randomized

Sponsor: University College, London

Principal Investigator:

Completion Date (primary or actual): June 16, 2021

CT.gov Identifier: NCT04851392

The purposes of the study are 1) to know the concentrations of Δ9-tetrahydrocannabinol (THC), cannabidiol (CBD) and other cannabinoids in blood, urine, oral fluid and sweat after the experimental administration of a standardized cannabis preparation orally (decoction and oil) and vaporized 2) to evaluate the pharmacological acute effects and tolerability

First Posted: April 12, 2021

Condition(s): Cannabis Use, Healthy Subjects

Intervention(s): Cannabis decoction, Cannabis oil, Vaporized cannabis

Status: Completed

Enrollment (expected or actual): 43

Allocation: Non-Randomized

Sponsor: Germans Trias i Pujol Hospital

Principal Investigator:

Completion Date (primary or actual): December 18, 2019

CT.gov Identifier: NCT04841993

The Cannabinoide Hyperemesis Syndrom (CHS) is defined as a recurrent syndrome of intractable vomiting that occurs in chronic cannabis consumers. The diagnosis is linked to clinical criteria only. The physiopathology of CHS is unknown and we observe an increase of cases with this syndrom since 2016 (Schreck et al., 2018). The aim of this study is to investigate the involvement of exogenous cannabinoids concentrations in chronic cannabis users in the occurrence of CHS.

First Posted: April 8, 2021

Condition(s): Chronic Consumption of Cannabis

Intervention(s): 1 blood sample

Status: Recruiting

Enrollment (expected or actual): 200

Allocation: N/A

Sponsor: Poitiers University Hospital

Principal Investigator:

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

CT.gov Identifier: NCT04836611

Cannabidiol (CBD) is a phytocannabinoid that is one of 113 identified cannabinoids in the cannabis plant. It is derived from the hemp plant, and may treat conditions like pain, insomnia, and anxiety. CBD is a critical component of medical marijuana and does not cause the "high" typically associated with cannabis. According to the World Health Organization, CBD has shown no evidence of abuse or dependence potential. However, to the investigator's knowledge, there have not been many acute clinical studies to characterize the effects of CBD in the brain. Despite the rapid influx in CBD readily available to the public, very little is known about such effects. Some studies have shown alterations in resting state connectivity, while others have described changes in specific regions of the brain, or in networks associated with various cognitive functions. For example, CBD has been shown to increase fronto-striatal connectivity and reduce mediotemporal-prefrontal connectivity, suggesting that CBD may affect brain regions involved in salience processing. Unfortunately, few studies have examined CBD in isolation. Additionally, several studies have suggested that CBD may have a neuroprotective effect when it comes to individuals at high risk for psychiatric conditions. In this study, the investigators propose an acute administration, double-blind, placebo-controlled study in which 100% THC-free CBD will be compared to placebo (https://foliumbiosciences.com/). To the investigator's knowledge, the acute effects of this specific product have not been tested. Specifically, the investigators will examine: 1) the neurometabolic and neurophysiological effects of CBD compared to placebo and 2) the behavioral effects of CBD on measures of working memory and response inhibition. Participants will be recruited to take encapsulated, THC-free CBD provided by Folium Biosciences, in which they will have a pre- and post-ingestion scan. Each participant will have a 72-hour washout period after which they will be asked to come back for a placebo scan (however, the order will be counterbalanced so that equal numbers of participants will receive placebo/supplement and supplement/placebo). Individuals will be randomized into the supplementation group, as well as the order.

First Posted: April 5, 2021

Condition(s): CBD, Fear, Inhibition

Intervention(s): Cannabidiol, Placebo

Status: Recruiting

Enrollment (expected or actual): 15

Allocation: Randomized

Sponsor: Auburn University

Principal Investigator: Jennifer L. Robinson, Ph.D., Professor

Completion Date (primary or actual): April 15, 2022

CT.gov Identifier: NCT04831294

This study will use a randomized controlled design to test whether medical marijuana use by adults on high-dose chronic opioid therapy (COT) for chronic non-cancer pain (CNCP) is associated with reduced opioid dose and improved pain intensity and interference when added to a 24-week behavioral intervention (POTS).

First Posted: April 1, 2021

Condition(s): Opioid Use, Pain, Marijuana Use

Intervention(s): Medical Marijuana, Prescription Opioid Taper Support (POTS)

Status: Recruiting

Enrollment (expected or actual): 250

Allocation: Randomized

Sponsor: Massachusetts General Hospital

Principal Investigator: Jodi Gilman, Assistant Professor

Completion Date (primary or actual): June 30, 2025

CT.gov Identifier: NCT04827992

This is a multi-site, double-blind, parallel group, randomized, placebo-controlled study of 140 participants comparing oral purified cannabidiol isolate (CBD) with placebo in reducing Severe Behavioral Problems (SBP) at 8 week in children aged 6 - 18 years with Intellectual Disability (ID). Eligible participants will be randomized 1:1 to receive either CBD or placebo.

First Posted: March 30, 2021

Condition(s): Intellectual Disability, Child Behavior Problem

Intervention(s): Cannabidiol Oil, Placebo

Status: Recruiting

Enrollment (expected or actual): 140

Allocation: Randomized

Sponsor: Murdoch Childrens Research Institute

Principal Investigator:

Completion Date (primary or actual): June 2023

CT.gov Identifier: NCT04821856

Clinical evidence about the effects of cannabis in the management of acute pain is rather scarce, mostly consisting of case report-based opinions on adverse events during or after general anesthesia after smoking cannabis, experimental pain trials in healthy volunteers, and a few clinical trials using different drugs, dosages and routes of administration. It is difficult to draw strong conclusions from the available evidence, that may seem sometimes even contradictory, mainly due -the investigators believe- to the many sources of variability in the study designs (e.g.: heterogeneity of the study samples, underpowered, unblinding, lack of randomization, timing of the therapeutic intervention, different experimental pain models, inclusion of different kind of surgical pain, etc.). Nevertheless, expert's opinion after a critical review of the literature is that cannabis and cannabinoids may have a beneficial role in the management of acute pain, at least for a selected group of patients and through an appropriate therapeutic intervention. Cannabis oil seem to be most suitable to our investigation. The co-administration of tetrahydrocannabinol (THC) with cannabidiol (CBD) may translate into additional therapeutic benefits with an attenuation of adverse effects. And will help treat acute radicular back pain

First Posted: March 25, 2021

Condition(s): Acute Radicular Back Pain, Cannabis

Intervention(s): Single-dose of cannabis oil, Control

Status: Recruiting

Enrollment (expected or actual): 200

Allocation: Randomized

Sponsor: Hadassah Medical Organization

Principal Investigator: Elyad Davidson, Director Pain Relief Unit

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

CT.gov Identifier: NCT04816994

Aims: To identify the predictors associated with smoking cessation in smokers under treatment for alcohol and/or cannabis treated in drug treatment centers (DTC). Methodology: Mixed methods project with qualitative and quantitative designs (three studies). Study I discussion groups: of clinical professionals of DTC to explore the barriers/facilitators of these smokers in quitting and the interventions carried out. Study II Prospective cohort of smokers in alcohol and/or cannabis treatment that will be followed-up for 12 months. Sample size: difference in incidence (exposed to cessation interventions versus non-exposed = 12 per 100 years), α = 0.05, β = 0.10, losses = 20% (n = 726). Dependent variables: self-reported and verified tobacco consumption abstinence, quit attempts, motivation, and self-efficacy. Independent variables: age, sex, the substance under treatment. Analysis: incidence, relative risk and simple and multiple logistic regression models (odds ratio and confidence interval, CI, 95%) of quitting. Study III discussion groups: with smokers under alcohol and/or cannabis treatment selected according to their typology. Analysis: of thematic content and triangulation qualitative and quantitative results. Expected results: Characterization of variables that influence tobacco cessation, to improve the design of interventions.

First Posted: April 12, 2021

Condition(s): Mental Health Disorder, Substance Abuse Drug, Alcohol Abuse, Cannabis Use, Tobacco Use, Smoking Cessation

Intervention(s):

Status: Recruiting

Enrollment (expected or actual): 1625

Allocation:

Sponsor: Institut Català d'Oncologia

Principal Investigator:

Completion Date (primary or actual): October 2021

CT.gov Identifier: NCT04841655

This is a multi-centre, long term, double blind, clinical protocol for NanaBis™ as a monotherapy treatment in participants 18-75 years of age with cancer related pain.

First Posted: March 22, 2021

Condition(s): Cancer Related Pain

Intervention(s): NanaBis™, Oxycodone CR, Placebo Spray, Placebo Tablet, Oxycodone IR

Status: Not yet recruiting

Enrollment (expected or actual): 360

Allocation: Randomized

Sponsor: Medlab Clinical

Principal Investigator:

Completion Date (primary or actual): February 2024

CT.gov Identifier: NCT04808531

This study applies a hypothesis-driven approach to examine the effects of chronic marijuana use on HIV-associated inflammation and its subsequent impacts on central nervous system function, with the goal of identifying the mechanisms through which cannabinoids modulate neurological disorders and other comorbidities in persons with HIV.

First Posted: March 23, 2021

Condition(s): Cannabis, HIV, Inflammation, Cognition, Neuroimaging

Intervention(s): Multimodal, multi-parametric MRI, Immune and cytokine profiling, Neuropsychological testing

Status: Recruiting

Enrollment (expected or actual): 220

Allocation: Non-Randomized

Sponsor: Duke University

Principal Investigator:

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

CT.gov Identifier: NCT04810858

Adults (ages 18+) who would like to reduce their cannabis use (N=224) will be enrolled in an 8-week treatment program. All participants will receive counseling (1 goals session with a therapist followed by 7 weekly computerized cognitive-behavioral therapy sessions). Detailed cannabis assessments (biological and self-report) will be conducted throughout treatment and at 1-, 2-, and 3-months post-treatment completion. Daily electronic diaries will be administered via text message to record detailed logs of cannabis use quantity and frequency. Salivary samples will be collected (and video observed) daily throughout treatment to analyze for progesterone.

First Posted: July 16, 2021

Condition(s): Cannabis Use Disorder, Mild, Cannabis Use Disorder, Moderate, Cannabis Use Disorder, Severe

Intervention(s): Cognitive Behavioral Therapy (CBT4CBT)

Status: Recruiting

Enrollment (expected or actual): 224

Allocation: Non-Randomized

Sponsor: Medical University of South Carolina

Principal Investigator: Rachel Tomko, PhD, Research Assistant Professor

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

CT.gov Identifier: NCT04964739

This study will address whether cannabis affects antiretroviral therapy (ART) drug concentrations, mood, and thinking. The project will have two phases. Phase 1 is an observational study, in which 120 people will be assessed to evaluate the effects of chronic cannabis use on ART drug concentrations, mood, and thinking. In Phase 2, the study will administer cannabis (or placebo) to 40 people to examine its acute effects on ART drug concentrations.

First Posted: March 16, 2021

Condition(s): HIV, Cannabis Use

Intervention(s): THC Cannabis, CBD Cannabis, Placebo

Status: Recruiting

Enrollment (expected or actual): 40

Allocation: Randomized

Sponsor: University of California, San Diego

Principal Investigator: Scott Letendre, Professor

Completion Date (primary or actual): January 30, 2025

CT.gov Identifier: NCT04800159

The purpose of this study is to determine the accuracy of an impairment algorithm based on eye tracking while watching a short film clip, in comparison to a clinical reference standard of impairment.

First Posted: March 16, 2021

Condition(s): Impairment, Cannabis Intoxication

Intervention(s): EyeBOX

Status: Completed

Enrollment (expected or actual): 225

Allocation:

Sponsor: Oculogica, Inc.

Principal Investigator:

Completion Date (primary or actual): September 7, 2021

CT.gov Identifier: NCT04799093

Glatt Pharmaceutical Services GmbH & Co. KG is developing a new CBD granules formulation (GLA-015 / Cannabidiol 1500 mg 29,7% w/w GRA BLD P) which is intended to be used in the treatment of the new Coronavirus disease 2019 (COVID-19). Due to its enhanced solubility the new product is expected to show increased bioavailability, reduced variability especially in the fasted state and better robustness towards food interaction compared to oil-based cannabidiol solutions. The aim of the present clinical trial is the characterisation of maximum systemic exposure of CBD and its active metabolite 7-OH-CBD of the newly developed Test product in the estimated target effective dose for treatment of COVID-19 as well as the comparison of its systemic bioavailability to CBD administered as oily solution. Comparison of maximum systemic exposure of Test vs. Reference will be performed under steady state conditions with twice daily intake after a light meal over 7 consecutive days.

First Posted: March 10, 2021

Condition(s): Comparative Bioavailability

Intervention(s): GLA-015, DAC C-052 "Cannabidiol" / NRF 22.10 "Oily cannabidiol solution 100 mg/ml"

Status: Completed

Enrollment (expected or actual): 18

Allocation: Randomized

Sponsor: SocraTec R&D GmbH

Principal Investigator:

Completion Date (primary or actual): April 16, 2021

CT.gov Identifier: NCT04790136

A randomized, open-label study of commercially available, orally ingestible, Cannabidiol (CBD) products used in the real-world setting for pain, sleep, and anxiety.

First Posted: August 13, 2021

Condition(s): Pain, Sleep Disturbance, Anxiety

Intervention(s): Commercially available, orally ingestible CBD product

Status: Completed

Enrollment (expected or actual): 3000

Allocation:

Sponsor: Radicle Science

Principal Investigator:

Completion Date (primary or actual): October 30, 2021

CT.gov Identifier: NCT05003882

Suicide is a major crisis worldwide with rates projected to continue to increase. There is currently a dearth of novel pharmacologic treatment options for suicide available on the market. The endocannabinoid system has been recently shown to be associated with mood disorders including suicidality. The aim of the study is to determine whether treatment with Nabilone is capable of reducing suicidal ideation in adults after 3 days.

First Posted: March 19, 2021

Condition(s): Suicidal Ideation

Intervention(s): Nabilone, Placebo

Status: Withdrawn

Enrollment (expected or actual): 0

Allocation: Randomized

Sponsor: The University of Texas Health Science Center, Houston

Principal Investigator: Rodrigo Machado-Vieira, MD, PhD, MSc, Professor of Psychiatry

Completion Date (primary or actual): April 2022

CT.gov Identifier: NCT04807829

Self-medication of pain by consuming alcohol and marijuana is common. However, the research regarding pain as a determinant for alcohol and marijuana use has relied on laboratory pain induction paradigms with limited clinical relevance. The study will assess demand for alcohol and marijuana before and after delayed onset muscle soreness (DOMS) induction in co-users. This will provide a clinically relevant, but time-limited, model for the effects of musculoskeletal pain on demand.

First Posted: March 10, 2021

Condition(s): Chronic Pain

Intervention(s): Eccentric Biceps Flexion, Concentric Biceps Flexion

Status: Completed

Enrollment (expected or actual): 51

Allocation: Randomized

Sponsor: University of Florida

Principal Investigator:

Completion Date (primary or actual): May 10, 2022

CT.gov Identifier: NCT04791917

This is a randomized, double-blind, within-subjects, cross-over design to assess neural changes following a single dose of cannabidiol (CBD) (600mg) versus placebo among healthy female volunteers.

First Posted: March 2, 2021

Condition(s): CBD, Neural Responses

Intervention(s): Cannabidiol, Placebo

Status: Recruiting

Enrollment (expected or actual): 10

Allocation: Randomized

Sponsor: Yale University

Principal Investigator:

Completion Date (primary or actual): February 28, 2023

CT.gov Identifier: NCT04777643

The purpose of the study is to develop and test social media interventions to help young people increase well-being and reduce risky behaviors. The study will help us learn about ways to deliver wellness information in a way that is appealing and helpful to young people that use social media. Eligible participants will be enrolled after baseline survey is completed. Participants will be involved with the secret social media group they are assigned to for 8 weeks. In addition, surveys will be completed at various times during and after the 8 week social media group.

First Posted: May 26, 2021

Condition(s): Cannabis Use

Intervention(s): Physical Activity (PA) Social Media Group, Verdi plus PA Social Media Group

Status: Completed

Enrollment (expected or actual): 60

Allocation: Randomized

Sponsor: University of Michigan

Principal Investigator: Erin Bonar, Associate Professor of Psychiatry, Medical School and Adjunct Associate Professor of Psychology

Completion Date (primary or actual): December 25, 2021

CT.gov Identifier: NCT04901910

Chronic pain affects at least 10% of the global population but is often poorly managed, given the variable efficacy of available pharmacological treatments and the limited accessibility of multidisciplinary interventions. The legalization of cannabis in at least 14 countries and the increasing regulatory approval of cannabis preparations and synthetic cannabinoids and analogues have led to a growing interest in the use of medical cannabis products to manage chronic pain. This use is supported by research demonstrating important interactions between cannabinoids and the human endocannabinoid system and pain modulation pathways. While medical cannabis products are increasingly available to practitioners who treat pain, there is little evidence-based guidance for prescribing or titrating these treatments to manage chronic non-cancer pain. This prospective registry aims to assemble real-world data regarding the use of Spectrum Therapeutics (ST) medical cannabis products in subjects with chronic non-cancer pain in Canada. The registry will also assess treatment outcomes, including pain and related symptoms, global impressions of improvement, and change in concomitant pain medications (opioid use in particular), to better inform the utility of ST products for chronic non-cancer pain management. Primary Objective: • To describe patterns of physician selection of Spectrum Therapeutics (ST) medical cannabis treatment regimen, expressed as average daily dose of THC and CBD (in mg), and mode of administration (ingested or inhaled), in the management of chronic non-cancer pain in countries where these products are commercially available. Secondary Objectives: To describe subject product and dose adjustment (under medical follow-up) over time. To assess outcomes of treatment, including pain relief and effects on sleep, daily functioning, and quality of life. To assess global impressions of treatment effectiveness as reported by subjects and physicians. To assess changes in daily dose of opioids, other medications over time. Safety Objective: • To assess the safety and tolerability of ST products in subjects with chronic pain.

First Posted: February 21, 2021

Condition(s): Chronic Pain

Intervention(s): Spectrum Therapeutics cannabis products

Status: Active, not recruiting

Enrollment (expected or actual): 407

Allocation:

Sponsor: Canopy Growth Corporation

Principal Investigator:

Completion Date (primary or actual): June 30, 2022

CT.gov Identifier: NCT04763252

This double-blind, placebo-controlled, proof-of-concept trial is designed to compare effects of oral CBD 600mg to placebo (PCB) in 40 outpatients with chronic spinal radiculopathies (without co-occurring Opioid Use Disorder), maintained on stable moderate to high-dose opioid analgesics for a minimum of 3-months, and motivated to decrease their opioid analgesic maintenance dose. The trial duration will be 6-months (from the point of randomization) and will include a 4-month treatment period (following randomization) of daily CBD 600mg vs placebo, followed by 2 months off of study medication or placebo. Safety and tolerability of CBD will be assessed throughout the trial. The primary efficacy outcome is change in opioid maintenance dose from baseline to end of the treatment period at 16-weeks post-randomization/initiation of treatment with a Mixed Model for Repeated Measures (MMRM) statistical analysis performed to assess between group treatment effects of CBD relative to placebo.

First Posted: February 18, 2021

Condition(s): Radiculopathy

Intervention(s): Cannabidiol, Placebo

Status: Recruiting

Enrollment (expected or actual): 60

Allocation: Randomized

Sponsor: NYU Langone Health

Principal Investigator:

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

CT.gov Identifier: NCT04760613