Systematically Testing the Evidence on Marijuana

The goal of the study is to evaluate how cannabis use affects memory and thinking skills and response to stress in older adults. The study will also relate cannabis use to Alzheimer's Disease (AD) biomarkers (measurable substances in blood that indicate condition), and test whether sex and hormones play a role in these effects. The study is recruiting adults between the ages of 50 and 80 who use cannabis products on a regular basis. Study participation will last about two weeks.

First Posted: October 11, 2021

Condition(s): Cannabis Use

Intervention(s): Trier Social Stress Task (TSST)

Status: Completed

Enrollment (expected or actual): 49

Allocation: N/A

Sponsor: Medical University of South Carolina

Principal Investigator: Andreana Benitez, Assistant Professor

Completion Date (primary or actual): June 7, 2023

CT.gov Identifier: NCT05072795

This pilot randomized controlled trial (RCT) will be conducted to evaluate the acceptability and feasibility of a digital tailored prevention tool (i.e., the Joint Effort mobile application) aimed at supporting university-level students into taking action on their cannabis use. The two main objectives of the proposed study are: To assess the acceptability of the Joint Effort mobile application in terms of uptake, engagement and intervention appreciation. To document the feasibility of the study processes in terms of online recruitment rate, adherence to online data collection methods, and attrition rate.

First Posted: October 29, 2021

Condition(s): Cannabis Use

Intervention(s): Joint Effort, Brief normative feedback and standard information

Status: Completed

Enrollment (expected or actual): 99

Allocation: Randomized

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Principal Investigator:

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

CT.gov Identifier: NCT05099016

Multiple sclerosis (MS) is an inflammatory disease of the central nervous system (CNS) afflicting over 77,000 Canadians. Unfortunately, the therapeutic arsenal to relieve MS symptoms is limited. It is therefore essential to develop better approaches to treat the symptoms of MS. The use of cannabis for recreational purposes is now legal in Canada. However, for many years, people with Multiple Sclerosis (PwMS) have used cannabis either to relax, to reduce pain and spasticity, or to improve sleep and daily functioning. Currently, there is little scientifically established evidence that cannabis works on these symptoms in people with MS. It is therefore important to carry out studies to better understand the efficacy Δ-9-tetrahydrocannabinol (THC), and cannabidiol (CBD) on MS symptoms . THC is known for its analgesic, neuroprotective and anti-inflammatory properties and CBD seems to have positive effects on anxiety and cognitive abilities (memory, concentration). For this study, investigators hypothesize that administering different doses of THC alone, CBD alone, and THC and CBD combined will result in a significant beneficial effect on spasticity relief compared to placebo.

First Posted: October 25, 2021

Condition(s): Multiple Sclerosis

Intervention(s): Cannabis oil vs placebo

Status: Recruiting

Enrollment (expected or actual): 250

Allocation: Randomized

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Principal Investigator:

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

CT.gov Identifier: NCT05092191

The purpose of this study is to determine the pharmacokinetics and pharmacodynamics of oral delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) and to evaluate detection of recently smoked THC in oral fluid.

First Posted: October 5, 2021

Condition(s): Drug Abuse, Intoxication by Drug, Impairment

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

Status: Not yet recruiting

Enrollment (expected or actual): 22

Allocation: Randomized

Sponsor: University of California, Los Angeles

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

Completion Date (primary or actual): March 2025

CT.gov Identifier: NCT05067387

This study will investigate whether cannabidiol (CBD), the primary centrally and peripherally active non-intoxicating compound in the cannabis plant, exerts anti-neuroinflammatory effects in patients with chronic low back pain (cLBP) with or without mild-to-moderate depression.

First Posted: October 4, 2021

Condition(s): Back Pain, Depressive Symptoms

Intervention(s): CBD, Placebo

Status: Recruiting

Enrollment (expected or actual): 80

Allocation: Randomized

Sponsor: Massachusetts General Hospital

Principal Investigator: Jodi Gilman, Associate Professor

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

CT.gov Identifier: NCT05066308

The purpose of the present study is to examine the pharmacokinetics and pharmacodynamics of cannabigerol (CBG; CHI-914), a naturally occurring chemical constituent of the cannabis plant formulated for oral consumption, in healthy adults. The study will utilize a within-subjects, placebo-controlled, double-blind, ascending-dose design.Upon enrollment, participants will complete 5 oral dosing conditions (placebo, 25, 50, 100, and 200 mg CBG). Each condition will consist of a single acute drug exposure, followed by an 8-hour period to evaluate acute pharmacodynamic and pharmacokinetic drug effects. This work will provide novel data on the pharmacokinetics, pharmacodynamic effects, and safety of acute oral CBG dose administration in humans.

First Posted: April 13, 2022

Condition(s): Behavioral Pharmacology of Cannabis

Intervention(s): Oral Placebo, Oral CBG Cannabis

Status: Recruiting

Enrollment (expected or actual): 30

Allocation: Randomized

Sponsor: Johns Hopkins University

Principal Investigator:

Completion Date (primary or actual): June 2025

CT.gov Identifier: NCT05324982

The overall objectives of this study are to investigate the efficacy of extended cannabis treatment to reduce patient exposure to prescription opioids through its use 1) as a non-opioid analgesic treatment, and 2) as a therapy for reducing high-dose opioid use in patients with chronic spine pain.

First Posted: September 22, 2021

Condition(s): Back Pain, Neck Pain

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

Status: Not yet recruiting

Enrollment (expected or actual): 157

Allocation: Randomized

Sponsor: University of Colorado, Denver

Principal Investigator:

Completion Date (primary or actual): June 2024

CT.gov Identifier: NCT05052541

This study will monitor for potential chronic liver injury and liver fibrosis, in participants treated with cannabidiol oral solution.

First Posted: September 16, 2021

Condition(s): Lennox Gastaut Syndrome, Dravet Syndrome, Tuberous Sclerosis Complex

Intervention(s): Cannabidiol

Status: Recruiting

Enrollment (expected or actual): 150

Allocation: N/A

Sponsor: Jazz Pharmaceuticals

Principal Investigator:

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

CT.gov Identifier: NCT05044819

This research study evaluates the effects of an FDA-approved medication Gabapentin in individuals with Bipolar Disorder who smoke marijuana. Participants in the study will will be assigned to take either Gabapentin or a matched placebo. Study medication will be taken for 17 days. There will be 5 study visits, with 2 MRI brain imaging scans completed. Questionnaires and clinical interview measures will be completed at study visits along with consistent assessment of potential side effects from study medication.

First Posted: October 1, 2021

Condition(s): Bipolar Disorder, Cannabis Use, Schizoaffective Disorder, Bipolar Type, Bipolar I Disorder, Bipolar II Disorder, Cannabis Use Disorder, Mild, Cannabis Use Disorder, Moderate, Cannabis Use Disorder, Severe

Intervention(s): Gabapentin, Placebo

Status: Recruiting

Enrollment (expected or actual): 68

Allocation: Randomized

Sponsor: Medical University of South Carolina

Principal Investigator: James J. Prisciandaro, Associate Professor

Completion Date (primary or actual): June 30, 2026

CT.gov Identifier: NCT05064319

This proposal's objective is to investigate the effects of topical cannabidiol (CBD) cream on exercise-induced muscle damage, exercise-induced inflammatory markers, and subsequent exercise performance after an exercise-induced damage protocol.

First Posted: September 16, 2021

Condition(s): Muscle Damage

Intervention(s): Cannabidiol Oil, Resistance Exercise

Status: Withdrawn

Enrollment (expected or actual): 0

Allocation: N/A

Sponsor: University of New Mexico

Principal Investigator:

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

CT.gov Identifier: NCT05044936

The purpose of this study is to determine the pharmacokinetics and pharmacodynamics of inhaled cannabis with varying amounts of delta-9-tetrahydrocannabinol (THC), and cannabidiol (CBD) and to evaluate detection of recently smoked THC in oral fluid.

First Posted: September 8, 2021

Condition(s): Drug Abuse, Intoxication by Drug, Impairment

Intervention(s): Placebo Cannabis, 20 mg CBD Cannabis, 20 mg CBD + 20 mg THC Cannabis, 20 mg THC Cannabis

Status: Recruiting

Enrollment (expected or actual): 22

Allocation: Randomized

Sponsor: University of California, Los Angeles

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

Completion Date (primary or actual): March 2024

CT.gov Identifier: NCT05037487

This single-site study is a pilot, three-armed, double-blinded, placebo-controlled randomized controlled trial (RCT) that will determine the feasibility of a definitive RCT investigating the use of cannabis oil as a treatment for insomnia in individuals with MDD. The study will also determine whether standard THC with higher CBD vs lower CBD has a differential impact on insomnia. The study will also analyze other important objective parameters of sleep including total sleep time and sleep efficiency from actigraphy data. Polysomnography data will also be analyzed. In addition, standardized, validated instruments will be used to collect data on severity of depressive symptoms, cognitive functioning biological rhythm disruption, daytime sleepiness, health-related quality of life (HRQoL), healthcare resource utilization, work productivity and activity impairment, as well as other side effects, in order to better understand the potential impact of the use of cannabis oil on these important health outcomes.

First Posted: September 13, 2021

Condition(s): Insomnia, Depressive Disorder, Major, Sleep Disorder, Depression, Insomnia Chronic

Intervention(s): 25:1 CBD/THC, 5:1 CBD/THC, Placebo

Status: Recruiting

Enrollment (expected or actual): 60

Allocation: Randomized

Sponsor: St. Joseph's Healthcare Hamilton

Principal Investigator: Benicio Frey, Professor of Psychiatry and Behavioural Neurosciences, Prinicipal Investigator

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

CT.gov Identifier: NCT05041647

Rationale: CBD is commonly being used as an over-the-counter treatment for musculoskeletal pain; however, no clinical trial has been performed to establish efficacy of CBD in humans for musculoskeletal pain. Hypothesis: CBD is more effective than placebo for relieving pain and improving patient-reported outcomes for musculoskeletal pain. Study Design: The study design with be a double-blind, randomized controlled trial with crossover. Treatment will be blinded to the subjects and investigators. Patients will be randomly assigned 2 weeks of the CBD or control and then crossover to the other condition for 2 additional weeks. Patients will apply the CBD or control cream to the affected area twice daily (approximately every 12 hours) for 1 hour. Subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects.

First Posted: December 28, 2021

Condition(s): Musculoskeletal Pain

Intervention(s): CBD

Status: Not yet recruiting

Enrollment (expected or actual): 100

Allocation: Randomized

Sponsor: University of Virginia

Principal Investigator: Brent DeGeorge, Assistant Professor of Plastic Surgery

Completion Date (primary or actual): June 2022

CT.gov Identifier: NCT05170451

Cannabidiol (CBD) has been approved as a treatment for rare childhood epilepsies and could be an effective treatment for psychotic disorders, anxiety disorders and addictions. It is available as an oral liquid and as standard oral capsules. The bioavailability of oral cannabidiol is poor (only around 5-10% is absorbed), particularly in the fasted state. With food, its absorption is much higher. In one study, a high-fat breakfast increased the maximum plasma concentration by 4-5 times. As a result of this food effect, when prescribing standard oral formulations of CBD, clinicians should provide advice on dosing the drug according to mealtimes, otherwise, there may be an increased risk of side effects or limited effectiveness. One way to reduce the food effect and improve bioavailability is to use lipid encapsulation. In the present study, the investigators will evaluate CBD at the dose that is effective in patients with chronic psychosis (1000mg). The novel formulation will use lipids that are all EU pharmacopoeia approved and have been used in medicinal products before. The study aims to assess whether a novel lipid formulation can increase the bioavailability of oral CBD in the fasting state.

First Posted: September 2, 2021

Condition(s): Absorption; Chemicals

Intervention(s): Cannabidiol standard formulation, Cannabidiol novel formulation

Status: Completed

Enrollment (expected or actual): 14

Allocation: Randomized

Sponsor: King's College London

Principal Investigator:

Completion Date (primary or actual): August 26, 2022

CT.gov Identifier: NCT05032807

The purpose of this study is to compare two commonly used agents for the treatment of cyclic vomiting to see if one agent is inferior to the other in time to improvement in symptoms, need for repeat or rescue medications, treatment failures and complications/side effects.

First Posted: October 4, 2021

Condition(s): Cyclic Vomiting Syndrome

Intervention(s): Droperidol, Haloperidol, Ondansetron 8mg

Status: Terminated

Enrollment (expected or actual): 38

Allocation: Randomized

Sponsor: Spectrum Health - Lakeland

Principal Investigator:

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

CT.gov Identifier: NCT05065567

Generalized anxiety disorder affects about 6.8 million adults in the United States, therefore its treatment is of major public health interest. Cannabidiol (CBD) has shown promise as an effective treatment for anxiety-related symptoms while lacking the severity of adverse effects seen with other medications. Given the wide availability of products containing CBD on the market today, from tinctures to coffee additives, and the undetermined potential for drug-to-drug interactions, medical supervision of CBD intake and formulation-specific clinical research is necessary. Therefore this study aimed to observe the effects of a specific hemp-derived full spectrum CBD formula on anxiety-related symptoms in a group of volunteers. The investigators will examine the self-reported anxiety symptoms in relation to use of a specific CBD formulation (25mg solvent-free full spectrum CBD capsules) in a cohort of adults diagnosed with generalized anxiety disorder. This open-label, cohort study will be conducted at six clinic sites in the United States (including Puerto Rico) from June 2020 through October 2020. The six physicians recruited to participate in the study were each actively prescribing CBD in their practices and were actively caring for patients with anxiety symptoms. Anxiety levels will be measured in enrolled participants diagnosed with generalized anxiety disorder each week for a period of eight weeks using the Generalized Anxiety Disorder 7-Item Scale (GAD7). Participants will also be instructed to take a daily 25mg capsule of CBD. The investigators hypothesize that this formula, when carefully developed and administered by a healthcare professional, will significantly reduce anxiety symptoms.

First Posted: August 27, 2021

Condition(s): Generalized Anxiety Disorder

Intervention(s): Formula30A Full Spectrum Hemp Cannabidiol 25mg Capsules

Status: Completed

Enrollment (expected or actual): 30

Allocation:

Sponsor: Formula30A LLC

Principal Investigator:

Completion Date (primary or actual): October 31, 2020

CT.gov Identifier: NCT05023759

The purpose of this prospective, randomized, double-blind, placebo-controlled trial is to assess the physiological, biochemical, and psychometric impacts of a brand-specific hemp-derived cannabidiol product in a sample of healthy adults.

First Posted: January 28, 2022

Condition(s): Healthy, Safety Issues

Intervention(s): Cannabinol, Placebo

Status: Completed

Enrollment (expected or actual): 56

Allocation: Randomized

Sponsor: University of South Carolina

Principal Investigator: Shawn M. Arent, Professor

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

CT.gov Identifier: NCT05212402

The overarching goal of this study is to evaluate the potential of Cannabidiol (CBD) as an adjunctive treatment for comorbid opioid use disorder (OUD) and chronic pain. This is a randomized, placebo-controlled, crossover human laboratory study investigating the dose-dependent safety and acute effects of CBD on measures of pain and opioid craving in outpatients with OUD receiving medication-assisted treatment (MAT) with methadone or buprenorphine.

First Posted: October 13, 2021

Condition(s): Addiction

Intervention(s): CBD Day 1, CBD Day 2, CBD Day 3

Status: Recruiting

Enrollment (expected or actual): 6

Allocation: Non-Randomized

Sponsor: Yale University

Principal Investigator: Joao De Aquino, Principal Investigator

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

CT.gov Identifier: NCT05076370

The purpose of this study is to see if cannabidiol (CBD) orally dissolving tablets (ODTs) can lessen pain, improve function, and improve patient satisfaction in cases of knee osteoarthritis. CBD comes from the cannabis plant and is non-psychoactive (i.e. does not produce a 'high' or altered mental state) as compared to tetrahydrocannabinol (THC), another compound found in cannabis. Researchers are studying different forms of CBD for potential use in treating pain, inflammation, and illnesses.

First Posted: August 25, 2021

Condition(s): Knee Arthritis

Intervention(s): Cannabidiol (CBD), Placebo

Status: Recruiting

Enrollment (expected or actual): 100

Allocation: Randomized

Sponsor: NYU Langone Health

Principal Investigator:

Completion Date (primary or actual): June 2024

CT.gov Identifier: NCT05020028

A Randomized Clinical Trial that will compare the effects of Cannabidiol and Homotaurine in cognition and mental health in patients with Mild Cognitive Impairment and APOE ε4 carriers. Ninety patients will be recruited and they will be randomly distributed in three groups. The first group will receive treatment with Cannabidiol 5%, the second group will receive treatment with Vivimind and the third group will not receive any treatment. The three groups will be compared by using an extensive neuropsychological examination and biomarkers' results from cerebrospinal fluid and blood

First Posted: August 26, 2021

Condition(s): Mild Cognitive Impairment

Intervention(s): Cannabidiol Oil, Homotaurine

Status: Recruiting

Enrollment (expected or actual): 90

Allocation: Randomized

Sponsor: Aristotle University Of Thessaloniki

Principal Investigator: Magda Tsolaki, Professor of Neurology, Medical School, Aristotle University of Thessaloniki

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

CT.gov Identifier: NCT05022186

There are no FDA approved treatments for use in adults with autism spectrum disorder (ASD), many of whom have distressing anxiety, mood disturbances, sleep problems, and agitation. Some researchers and individuals with ASD have noted that cannabidiol (CBD) is beneficial for those psychiatric problems. This study is to learn more about the effectiveness and safety of CBD in the treatment of psychiatric problems in adults with ASD. The study will last 14 weeks total, during which six weeks participants will receive a pill containing CBD, two weeks where participants will receive no drug/placebo, and six weeks where participants will receive the placebo, an inactive pill. As part of the study, participants will have regular visits and be asked questions about anxiety, challenging behaviors, daily functioning, cognition, and physical symptoms, on standard assessments.

First Posted: August 20, 2021

Condition(s): Autism Spectrum Disorder

Intervention(s): Cannabidiol, Placebo

Status: Recruiting

Enrollment (expected or actual): 40

Allocation: Randomized

Sponsor: Johns Hopkins University

Principal Investigator:

Completion Date (primary or actual): December 2023

CT.gov Identifier: NCT05015439

This open-label, 3-period, 3-treatment, randomized study will characterize the pharmacokinetics and safety and tolerability of SP-104 under fasting and fed conditions as compared to the pharmacokinetics of Naltrexone Hydrochloride Tablets, USP, 50 mg in healthy adult subjects.

First Posted: August 12, 2021

Condition(s): Healthy

Intervention(s): SP-104, Naltrexone Hydrochloride 50Mg Oral Tablet

Status: Completed

Enrollment (expected or actual): 18

Allocation: Randomized

Sponsor: Scilex Pharmaceuticals, Inc.

Principal Investigator:

Completion Date (primary or actual): April 24, 2022

CT.gov Identifier: NCT05002946

Double-blind, randomized into two arms (TC and TP): patients get either topical cannabidiol or topical placebo up to three times daily. Inclusion criteria will be chronic joint pain with intent to treat or currently treated with opioids. Exclusion criteria will include current cannabis use, severe medical illness or lacking in capacity to be involved in study. TC and TP will be prescribed for use TID in predefined dosages and quantities.

First Posted: August 12, 2021

Condition(s): Musculoskeletal Joint Pain

Intervention(s): Cannabidiol, Placebo

Status: Withdrawn

Enrollment (expected or actual): 0

Allocation: Randomized

Sponsor: Louisiana State University Health Sciences Center Shreveport

Principal Investigator: James C. Patterson, II, MD. Ph, Clinical Director, Louisiana Addiction Research Center

Completion Date (primary or actual): January 2023

CT.gov Identifier: NCT05002114

The study aims to evaluate the effect of Dorsolateral Prefrontal Cortex (DLPFC) Transcranial Direct Current Stimulation (tDCS) in decreasing distress and cannabis use. 46 participants with Relapse Remitting Multiple Sclerosis (RRMS), Cannabis Use Disorder (CUD) and elevated distress (K10 score of 10-35) will be recruited.

First Posted: August 13, 2021

Condition(s): Cannabis Use Disorder, Multiple Sclerosis

Intervention(s): Transcranial Direct Current Stimulation (tDCS), Sham - Transcranial Direct Current Stimulation (tDCS), Mindfulness

Status: Recruiting

Enrollment (expected or actual): 46

Allocation: Randomized

Sponsor: NYU Langone Health

Principal Investigator:

Completion Date (primary or actual): February 29, 2024

CT.gov Identifier: NCT05005013

This observational study aims to improve our understanding of how legal market cannabis use impacts acute and long-term alcohol use, the microbiota-gut-brain-axis (MGBA), and neurobehavioral alcohol use phenotypes such as impulsivity, impaired cognitive functioning, and craving, among individuals who regularly use both alcohol and cannabis. Over a period of one month, subjects will participate in this three-visit study. Blood samples will be collected to allow for the assessment of inflammatory markers and cannabinoids, a fecal sample will be collected to allow for the analysis of the gut microbiome, and participants will complete cognitive and impulsivity tasks and provide craving ratings during the course of an alcohol self-administration procedure. Subjects will also participate in two 14-day daily diary data collection periods between lab sessions. Daily diary data collection will be used to assess the effects of cannabis use on alcohol use and craving longitudinally.

First Posted: August 10, 2021

Condition(s): Cannabis Use, Alcohol Use, Inflammation

Intervention(s): Alcohol and Cannabis vs. Alcohol only

Status: Recruiting

Enrollment (expected or actual): 61

Allocation:

Sponsor: Colorado State University

Principal Investigator: Hollis Karoly, Assistant Professor

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

CT.gov Identifier: NCT04998006