Systematically Testing the Evidence on Marijuana

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: Recruiting

Enrollment (expected or actual): 56

Allocation: Randomized

Sponsor: University of South Carolina

Principal Investigator: Shawn M. Arent, Professor

Completion Date (primary or actual): August 2022

CT.gov Identifier: NCT05212402

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): September 20, 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: Not yet recruiting

Enrollment (expected or actual): 18

Allocation: N/A

Sponsor: University of New Mexico

Principal Investigator:

Completion Date (primary or actual): June 2022

CT.gov Identifier: NCT05044936

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): April 30, 2022

CT.gov Identifier: NCT05076370

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: 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): November 2023

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: Not yet 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): November 30, 2022

CT.gov Identifier: NCT05041647

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: Recruiting

Enrollment (expected or actual): 100

Allocation: Randomized

Sponsor: Spectrum Health - Lakeland

Principal Investigator:

Completion Date (primary or actual): June 2023

CT.gov Identifier: NCT05065567

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: Not yet recruiting

Enrollment (expected or actual): 14

Allocation: Randomized

Sponsor: King's College London

Principal Investigator:

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

CT.gov Identifier: NCT05032807

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 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: Not yet recruiting

Enrollment (expected or actual): 100

Allocation: Randomized

Sponsor: NYU Langone Health

Principal Investigator:

Completion Date (primary or actual): June 2023

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: Not yet recruiting

Enrollment (expected or actual): 40

Allocation: Randomized

Sponsor: Johns Hopkins University

Principal Investigator:

Completion Date (primary or actual): August 2023

CT.gov Identifier: NCT05015439

The purpose of this study is to examine the pharmacokinetics and pharmacodynamics of a hemp-derived oral product containing cannabidiol (CBD) and cannabidiolic acid (CBD-A) at a 1:1 ratio.

First Posted: September 20, 2021

Condition(s): Cannabis

Intervention(s): CBD 1mg/Kg, CBD 2mg/Kg, CBD 4mg/Kg, Placebo CBD

Status: Recruiting

Enrollment (expected or actual): 50

Allocation: Randomized

Sponsor: Johns Hopkins University

Principal Investigator:

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

CT.gov Identifier: NCT05049733

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: Not yet recruiting

Enrollment (expected or actual): 20

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): July 2022

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: Not yet recruiting

Enrollment (expected or actual): 46

Allocation: Randomized

Sponsor: NYU Langone Health

Principal Investigator:

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

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

This is an open label, phase 2 clinical trial to assess the feasibility of a cannabidiol (CBD) dominant medicinal cannabis for the treatment of Long COVID. The primary aim is to assess the feasibility of recruiting and retaining individuals diagnosed with Long COVID into a treatment trial of medicinal cannabis, as well as assessing the safety and tolerability of a dominant medicinal cannabis in this population. The secondary aim is to determine the effect of a CBD dominant medicinal cannabis on symptoms associated with Long COVID.

First Posted: August 9, 2021

Condition(s): Long COVID

Intervention(s): MediCabilis Cannabis sativa 50

Status: Not yet recruiting

Enrollment (expected or actual): 30

Allocation: N/A

Sponsor: Drug Science, UK

Principal Investigator: Elizabeth Iveson, Principal Investigator

Completion Date (primary or actual): December 2022

CT.gov Identifier: NCT04997395

This clinical trial is being done to better understand how daily treatment with Tetrahydrocannabinol (THC), Cannabidiol (CBD), or the combination of CBD plus THC affects knee osteoarthritis pain and other related symptoms. Consented participants will have a screening period and visit (up to 30 days to treatment start). If participants pass the screening phase, they will be randomly assigned to take one of the investigational study drugs. For this study, participants will not know when or if they are taking CBD, THC, THC plus CBD, and when or if taking placebo. Clinical pain will be assessed at multiple times throughout the study, and eligibility will be re-assessed at two weeks into the treatment period. It is possible that subjects will not be able to participate in the study after 14 days of of treatment. The treatment period will take approximately 16 weeks and then a follow-up period for approximately 2 weeks. In addition to treatment, participants will have clinical assessments, blood draws, questionnaires, daily pain diaries, sensory testing, as well as have functional connectivity magnetic resonance imaging (fcMRI).

First Posted: August 5, 2021

Condition(s): Osteoarthritis, Knee, Osteoarthritis of the Knee

Intervention(s): Placebo, Cannabidiol (CBD), Tetrahydrocannabinol (Marinol® or generic equivalent (e.g., dronabinol)

Status: Recruiting

Enrollment (expected or actual): 200

Allocation: Randomized

Sponsor: Richard Harris

Principal Investigator: Richard Harris, Associate Professor of Anesthesiology and Associate Professor of Internal Medicine

Completion Date (primary or actual): September 2025

CT.gov Identifier: NCT04992624

To evaluate the effect of the cannabidiol (CBD) + cannabigerol (CBG) + tetrahydrocannabinol (THC) up to 133/66/4mg daily versus placebo as adjuvant treatment in chronic migraine (CM) patients under preventive treatment at a stable dose for at least 3 months who present at least 5 headaches day a month. CM patients of both sexes, between 25 and 65 years old, who have not had CBD and/or THC as a migraine treatment. Patients may be having migraine preventive treatment such as propranolol, topiramate, valproic acid/sodium valproate, flunarizine, amitriptyline, nortriptyline, candesartan, galcanezumab, erenumab, fremanezumab, botulinum toxin type A. Acute treatment will follow patients doctor's prescription. Exclusion criteria: active liver disease or elevated liver transaminases> 3 times than the normal values, pregnancy, fertile age women without contraceptive treatment or who intend to get pregnant, patients without migraine preventive treatment, substance abuse or addiction, use of medical cannabis or products with CBD or THC in the last 30 days or during study period, history of allergy or adverse reactions with the use of CBD or related products, substance users of liver enzymes inducers such as rifampicin, ketoconazole, theophylline, carbamazepine, phenytoin, phenobarbital and St. John's wort. Patients on vitamin K anticoagulant medicines, as warfarin. After randomization patients will be divided into two groups of 55 participants, who will receive CBD + CBG + THC up to a maximum dose of 133/66/4 mg or placebo for 12 weeks (V0 screening, V1 allocation, V4 final visit). The main outcome is the reduction in frequency of headache days per 4 weeks between V1 and V4 compared to placebo. Secondary outcomes will be a reduction in duration and intensity of migraine attacks, amount of painkillers used and percentage of patients with a reduction greater than 50% on migraine days, 50% reduction in the other variables as MIDAS scores, HIT-6 scores, Beck's Anxiety and Depression Scales, Epworth Sleepiness Scales, and the scores at The Severity of Dependence Scale used as an indicator of overuse medication in this sample. The clinical and laboratory data obtained in this study will comply with the objectives elaborated in the evaluation of the primary and secondary, the proposal of which is to publish the data regardless of the results obtained.

First Posted: August 4, 2021

Condition(s): Chronic Migraine, Headache, Overuse Headache Medication

Intervention(s): Placebo oral drops, Cannabidiol + Cannabigerol + Tetrahydrocannabinol 133/66/4mg

Status: Not yet recruiting

Enrollment (expected or actual): 110

Allocation: Randomized

Sponsor: Hospital Israelita Albert Einstein

Principal Investigator: Alexandre Kaup, Principal Investigator, MD

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

CT.gov Identifier: NCT04989413

The study examined a community based cannabis cessation program in Norway (CCP). The CCP uses a combination of cognitive therapy and psychoeducation and covers the normal withdrawal period for cannabis smoking cessation (up to 8 weeks), comprising ~15 individual sessions. From 2005 onwards, the CCP was implemented as a low-threshold community-based program in several Norwegian municipalities, e.g., Kristiansand, Fredrikstad and Oslo. The study had an observational one-group pre- / post test design. Outcomes was changes in cannabis use, mental distress, well-being, social network and sense of coherence (SoC) measured post-intervention (T2) and at a 3 months follow-up (T3).

First Posted: August 4, 2021

Condition(s): Cannabis Use

Intervention(s): Cannabis cessation Program

Status: Completed

Enrollment (expected or actual): 102

Allocation:

Sponsor: Sorlandet Hospital HF

Principal Investigator:

Completion Date (primary or actual): January 31, 2017

CT.gov Identifier: NCT04989205

The American Academy of Pain Medicine has labeled pain as a "silent epidemic" due to its staggering costs to society (over $500 billion/year) and widespread prevalence (affects over 100 million Americans)(Institute of Medicine (US) Committee on Advancing Pain Research, 2011; Summers B, 2005). Thus, it is imperative to test and validate cost-effective pain therapies. To this extent, cannabis is characterized as one of the most promising therapies to treat a wide spectrum of pain conditions (Andreae et al., 2015; Baker, Pryce, Giovannoni, & Thompson, 2003; Bostwick, 2014; Haroutounian et al., 2016; Shohet, Khlebtovsky, Roizen, Roditi, & Djaldetti, 2017). However, the clinical applicability of cannabis-based pain therapies has been limited due to lacking mechanistic characterization in human-focused studies. Of critical importance, the neural mechanisms supporting cannabis induced pain relief remain unknown. The primary objective of the proposed pilot study is to identify the brain mechanisms supporting the direct alleviation of acutely evoked pain through vaporized cannabis.

First Posted: July 29, 2021

Condition(s): Healthy and Chronic Pain Patients

Intervention(s): Active Cannabis, Placebo Cannabis

Status: Not yet recruiting

Enrollment (expected or actual): 100

Allocation: Randomized

Sponsor: University of California, San Diego

Principal Investigator: Fadel Zeidan, Associate Professor of Anesthesiology

Completion Date (primary or actual): August 2024

CT.gov Identifier: NCT04982965

The goal of the proposed study is to evaluate the safe and efficacy of Epidiolex (cannabidiol) in adults with obsessive compulsive disorder (OCD). Subjects will be treated in an open-label fashion with Epidiolex for two weeks.

First Posted: July 27, 2021

Condition(s): Obsessive-Compulsive Disorder

Intervention(s): Cannabidiol

Status: Recruiting

Enrollment (expected or actual): 15

Allocation: N/A

Sponsor: University of Chicago

Principal Investigator:

Completion Date (primary or actual): September 2023

CT.gov Identifier: NCT04978428

This is a non-randomised, single arm, open-label study of medical cannabis, Cybis™ 10:25, in participants with chronic back or neck pain in which participants receive escalating doses of Cybis™ 10:25.

First Posted: July 26, 2021

Condition(s): Chronic Pain, Neck Pain, Back Pain, Pain, Pain, Chronic, Pain, Back, Pain, Neck, CBD, THC

Intervention(s): Cybis™ 10:25 THC:CBD oil

Status: Recruiting

Enrollment (expected or actual): 24

Allocation: N/A

Sponsor: Cymra Life Sciences

Principal Investigator:

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

CT.gov Identifier: NCT04976738

The purpose of this study is to determine the impact of cannabidiol on reward- and stress-related neurocognitive processes among individuals with opioid use disorder on buprenorphine or methadone treatment.

First Posted: July 29, 2021

Condition(s): Opioid-use Disorder

Intervention(s): Cannabidiol 100 MG/ML [Epidiolex], Placebo

Status: Recruiting

Enrollment (expected or actual): 10

Allocation: Randomized

Sponsor: Brigham and Women's Hospital

Principal Investigator: Joji Suzuki, MD, Director, Division of Addiction Psychiatry

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

CT.gov Identifier: NCT04982029