Search Results (1803)
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The Neural Underpinnings of Depression and Cannabis Use in Young People Living With HIV
To elucidate mechanisms of substance use disorders (SUD) and comorbid mental illnesses in people living with HIV (PLWH), the investigators propose to investigate reward and pain circuitry in cannabis use and depression comorbidity, two highly prevalent conditions in PLWH. The study will take place in our health system in The Bronx-a persistent epicenter of the HIV epidemic due to profound poverty and health disparities. The focus is on young adults (ages 18-34) to minimize HIV chronicity effects and due to the high rates of SUD and reduced adherence to HIV treatments in this age group; among >31,000 diagnosed young PLWH in The Bronx in 2019, less than 70% had suppressed (<200 copies/mL) viral load (VL).
First Posted: July 12, 2022
Condition(s): Hiv, Depression, Cannabis Use Disorder
Intervention(s): MRI study - everyone scanned.
Status: Recruiting
Enrollment (expected or actual): 280
Allocation: N/A
Sponsor: Albert Einstein College of Medicine
Principal Investigator: Vilma Gabbay, PRIME Director
Completion Date (primary or actual): July 1, 2026
Oral Cannabidiol for Tobacco Cessation
Cannabidiol is a compound found in cannabis plants that is well tolerated, has low abuse liability, and might be an effective medication to promote tobacco cessation. This clinical study will use a validated approach for screening tobacco cessation medications to determine if oral cannabidiol increases short-term tobacco abstinence, and evaluate mechanisms that might explain how cannabidiol alters smoking behavior. Results from this study will provide data on the therapeutic potential of cannabidiol for tobacco cessation.
First Posted: July 6, 2022
Condition(s): Tobacco Use, Tobacco Smoking, Tobacco Dependence, Tobacco Use Disorder, Tobacco Use Cessation
Intervention(s): 300 mg Cannabidiol, 600 mg Cannabidiol, Placebo
Status: Recruiting
Enrollment (expected or actual): 50
Allocation: Randomized
Sponsor: Johns Hopkins University
Principal Investigator:
Completion Date (primary or actual): August 1, 2023
Effect of Cannabis (Marijuana) on Stomach Emptying Before Surgery
The purpose of this research is to study the effect of cannabis (marijuana) on gastric (stomach) emptying before surgery. The study will include people who use cannabis (study group) and people who do not use cannabis (control group).
First Posted: June 29, 2022
Condition(s): Gastric Emptying, Cannabis
Intervention(s):
Status: Not yet recruiting
Enrollment (expected or actual): 108
Allocation:
Sponsor: The Guthrie Clinic
Principal Investigator:
Completion Date (primary or actual): March 1, 2023
MEDical CANnabis for Improving Symptoms During Severe DEMentia Disorders in Long-term Care Facility in Geneva
The behavioral and psychological symptoms of dementia affect up to 80% of long-term facilities residents with severe dementia. They seriously alter the quality of life of patients, relatives, and health professionals. Management involves correcting somatic and psychiatric factors and implementing non-drug interventions. Nevertheless, often drug treatments must be introduced with the limitations related to their effectiveness and adverse effects.
The investigators hypothesize that medical cannabinoids will improve neuropsychiatric and behavioral symptoms of patients with severe dementia.
The investigators assessed the feasibility and safety of administering a cannabis oil that contains tetrahydrocannabinol (THC) and Cannabidiol (CBD) during an initial study of about two years, observing an overall improvement, excellent tolerance to the treatment, and the possibility of reducing or even stopping other drugs.
This research project aims to study the efficacy of medical cannabis oil in improving the quality of life of dementia patients experimenting with behavioral and psychological symptoms.
First Posted: June 27, 2022
Condition(s): Dementia With Behavioral Disturbance
Intervention(s): Cannabis Sativa Oil, Placebo
Status: Not yet recruiting
Enrollment (expected or actual): 24
Allocation: Randomized
Sponsor: Fondation pour l'accueil et l'hébérement des personnes âgées
Principal Investigator:
Completion Date (primary or actual): September 2023
Cannabis, HIV and Mental Processing Systems
This study employs novel methods to identify key determinants and consequences of concurrent HIV infection and regular cannabis use. This study will acquire extensive phenotype data from peripheral and brain markers of immune activation, brain structure, and neuropsychological performance (NP) in persons living with HIV (PLWH) receiving combination anti-retroviral therapy (cART) (80 regular cannabis users and 80 non-users) and HIV uninfected (HIV-) controls (80 regular cannabis users and 80 non-users). This study will provide key insights into the effects of regular cannabis and HIV on peripheral and brain markers of immune function and NP in PLWH and HIV- controls. These insights are critical for cure strategies and ongoing HIV treatment initiatives.
First Posted: June 24, 2022
Condition(s): HIV Infections, Cannabis
Intervention(s): MRI, NeuroPsychological Testing, Blood Draw, Questionnaires, Lumbar Puncture
Status: Enrolling by invitation
Enrollment (expected or actual): 320
Allocation:
Sponsor: Washington University School of Medicine
Principal Investigator:
Completion Date (primary or actual): June 30, 2025
Behavioral Pharmacology of THC and Beta-Myrcene
This study will evaluate the pharmacokinetics and pharmacodynamics of vaporized b-myrcene and THC administered via inhalation.
First Posted: June 27, 2022
Condition(s): Cannabis Use
Intervention(s): Placebo, THC, Beta-Myrcene
Status: Not yet recruiting
Enrollment (expected or actual): 32
Allocation: Randomized
Sponsor: Johns Hopkins University
Principal Investigator:
Completion Date (primary or actual): November 2025
Dose-Ranging Trial of Inhaled Cannabis for Acute Migraine Treatment
This pilot crossover study will evaluate 3 different potencies of inhaled cannabis (2.5%, 5%, and 10%) and inhaled placebo cannabis for the acute treatment of migraine.
First Posted: June 22, 2022
Condition(s): Migraine, Cannabis, THC
Intervention(s): THC ~2.5%, THC ~5%, THC ~10%, Sham Cannabis
Status: Not yet recruiting
Enrollment (expected or actual): 20
Allocation: Randomized
Sponsor: University of California, San Diego
Principal Investigator: Nathaniel Schuster, Associate Professor
Completion Date (primary or actual): December 1, 2024
Investigating the Neural Correlates of Cognitive Function in Psychosis Patients and Non-Psychiatric Controls With Cannabis Use
Cognitive impairment is well established in people with psychosis and is associated with cannabis use. The current study will investigate the neurobiological basis of cognitive change associated with 28-days of cannabis abstinence in people with psychosis and non-psychiatric controls with cannabis use. Participants will be randomized to a cannabis abstinent group or a non-abstinent control group and will undergo magnetic resonance imaging at baseline and following 28-days of abstinence. This study will help characterize the neuropathophysiological processes underlying cognitive dysfunction associated with cannabis use and its recovery which may guide the development of novel interventions for problematic cannabis use.
First Posted: July 6, 2022
Condition(s): Psychotic Disorders, Cannabis Use Disorder, Cannabis Dependence, Cannabis Use, Schizophrenia; Psychosis, Cognitive Dysfunction, Memory Impairment, Neuroimaging
Intervention(s): Contingency management
Status: Recruiting
Enrollment (expected or actual): 134
Allocation: Randomized
Sponsor: Douglas Mental Health University Institute
Principal Investigator: Rachel Rabin, Assistant Professor
Completion Date (primary or actual): May 2027
SV2A in Older Adults
The aim of the study is to examine the effect of cannabis use on brain synaptic density among older adults using [11C]UCB-J PET imaging.
First Posted: July 19, 2022
Condition(s): Cannabis Use
Intervention(s): [11C]UCB-J PET
Status: Recruiting
Enrollment (expected or actual): 24
Allocation: Non-Randomized
Sponsor: Yale University
Principal Investigator: Rajiv Radhakrishnan, Principal Investigator
Completion Date (primary or actual): June 30, 2023
A Trial to Assess the Efficacy and Safety of Medical Grade Cannabis in Children Diagnosed With Autism Spectrum Disorder
This single center, double-blinded, randomized, placebo-controlled crossover trial will assess the efficacy and safety of extraction of cannabis flowers dissolved in olive oil (30% CBD and 1.5% Δ9-THC) vs. placebo in patients diagnosed with Autism Spectrum Disorder. The trial will contain two phases in which patients will first receive a twelve-week treatment of either cannabis or placebo followed by four weeks wash out period and another twelve weeks of crossover in the trial arms.
First Posted: June 9, 2022
Condition(s): Autistic Disorder
Intervention(s): Medical Grade Cannabis oil, Placebos
Status: Withdrawn
Enrollment (expected or actual): 0
Allocation: Randomized
Sponsor: TO Pharmaceuticals
Principal Investigator:
Completion Date (primary or actual): September 1, 2022
A Study of Ingested Cannabidiol in Healthy Occasional Cannabis Users
The purposes of this study are 1) to determine if the administration of different low doses of oral CBD (20 mg, 50 mg, 100 mg and 200 mg) result in detectable subjective pleasant drug effect compared to placebo and 2) to qualitatively explore whether low dose of oral CBD is associated with effects that are not detected with the available research tools.
First Posted: June 7, 2022
Condition(s): Cannabis
Intervention(s): cannabis 0 mg, placebo, Cannabis 20 mg,, Cannabis 50 mg, Cannabis 100 mg, Cannabis 200 mg
Status: Recruiting
Enrollment (expected or actual): 70
Allocation: Randomized
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Principal Investigator:
Completion Date (primary or actual): July 2023
Transcranial Magnetic Brain Stimulation to Reduce Cannabis Use in Heavy Cannabis Users
The growing legalization of cannabis across the U.S. is associated with increases in cannabis use, and accordingly, an increase in the number of individuals with cannabis use problems, including cannabis use disorder (CUD). While there are several medications being investigated as treatment options for CUD, none have been FDA-approved, and there is limited efficacy of traditional behavioral therapy approaches for this population. Consequently, there is a pressing need for the development of new treatments, including approaches that specifically target the brain areas associated with problematic cannabis use behaviors. Elevated attention to drug cues is one of the primary causes of relapse in heavy cannabis users. Preliminary data suggests that transcranial magnetic stimulation (TMS), a non-invasive form of brain stimulation, may be a novel brain-based tool to decrease heightened attention to drug cues in people with CUD. Building on prior data, the primary goal of this study is to evaluate the feasibility and effectiveness of TMS as a tool to decrease attention to drug cues and reduce cannabis use.
This study will evaluate whether 2 weeks of rTMS can be used to decrease attentional bias to cannabis cues and reduce cannabis use in heavy cannabis users. We will recruit sixty (60) non-treatment seeking, near-daily cannabis users to receive 10 daily sessions of either real or sham (aka placebo) rTMS over a 2-week period. Participants will live on a residential research unit for 3 weeks. During the residential stay, data on cannabis use (measured using standard human laboratory measures of choice to smoke cannabis) and relevant brain activity (measured using drug cue exposure fMRI tasks) will be collected before and after the course of 10 daily rTMS sessions. We will aim to show whether real rTMS treatment reduces brain response and attentional bias to cannabis cues and reduces cannabis use levels.
First Posted: June 2, 2022
Condition(s): Cannabis
Intervention(s): iTBS, iTBS
Status: Recruiting
Enrollment (expected or actual): 40
Allocation: Randomized
Sponsor: New York State Psychiatric Institute
Principal Investigator: Tonisha Kearney-Ramos, Research Scientist III/Assistant Professor of Clinical Neurobiology (in Psychiatry)
Completion Date (primary or actual): July 2027
Cannabis' Impact on Alcohol Consumption
This study employs a repeated measures experimental design to examine the effect of THC-dominant dose of cannabis and CBD-dominant dose of cannabis, relative to placebo, on subsequent drinking in an alcohol choice task in which participants choose either to drink or receive monetary reinforcement for drinks not consumed. Cannabis will be administered simultaneously with an alcohol-priming dose or alcohol placebo.
The study will enroll up to 350 nontreatment-seeking heavy episodic alcohol drinkers who use cannabis weekly.
First Posted: May 25, 2022
Condition(s): Alcohol Drinking, Cannabis Use, Cannabis, Alcohol Use Disorder
Intervention(s): THC-dominant cannabis, CBD-dominant cannabis, Cannabis placebo, Alcohol, Alcohol placebo
Status: Not yet recruiting
Enrollment (expected or actual): 350
Allocation: Randomized
Sponsor: Brown University
Principal Investigator:
Completion Date (primary or actual): March 2027
The Efficacy and Neurobehavioural Mechanism of Cannabidiol (CBD) for Alcohol Dependence
The study will explore the psychophysiological and neurobiological and mechanisms of CBD in participants with alcohol use disorder
First Posted: May 24, 2022
Condition(s): Alcohol Use Disorder (AUD)
Intervention(s): Cannabidiol (CBD), Placebo
Status: Recruiting
Enrollment (expected or actual): 20
Allocation: Randomized
Sponsor: South West Sydney Local Health District
Principal Investigator: Kirsten Morley BPsych MPH PhD, Associate Professor Kirsten Morley
Completion Date (primary or actual): June 2023
Topical Cannabidiol for the Treatment of Chemotherapy-Induced Peripheral Neuropathy
This clinical trial compares topical cannabidiol to placebo in improving chemotherapy-induced peripheral neuropathy, or painful sensations in your hands or feet due to chemotherapy. Peripheral neuropathy is a nerve problem that causes pain, numbness, tingling, swelling, or muscle weakness in different parts of the body. It usually begins in the hands or feet and gets worse over time. Peripheral neuropathy caused by chemotherapy is called chemotherapy-induced peripheral neuropathy (CIPN). CIPN is commonly seen in patients receiving certain chemotherapy medications and is hard to treat. Medications commonly used to treat CIPN have limited benefits and may cause significant side effects. A small report showed that topical cannabidiol may help treat neuropathy in patients with diabetes. This study is being done to determine if cannabidiol cream can help improve the symptoms of CIPN.
First Posted: May 24, 2022
Condition(s): Chemotherapy-Induced Peripheral Neuropathy, Malignant Solid Neoplasm
Intervention(s): Cannabidiol, Placebo Administration, Quality-of-Life Assessment, Questionnaire Administration
Status: Recruiting
Enrollment (expected or actual): 40
Allocation: Randomized
Sponsor: Mayo Clinic
Principal Investigator:
Completion Date (primary or actual): April 1, 2023
Cannabis Tolerance Break Resource Study: T-Break Guide
The purpose of this pilot study is to conduct research into the value of using the T-Break Guide for assisting people taking a tolerance break from cannabis. The hope is that this initial research will yield some insights and benchmarks into the Guide's efficacy, and provide a foundation for a later randomized control study.
The following are some key research questions:
How did participants use the Guide? (Eg: daily; read once; 'a la carte')
How did using the Guide increase fidelity to tolerance break (starting, continuing, completing a break)?
Did using the Guide yield any benefits beyond tolerance break fidelity? (Eg: insight into patterns of use)
First Posted: May 19, 2022
Condition(s): Cannabis Use, Tolerance, Cannabis Withdrawal
Intervention(s): T-Break Guide
Status: Completed
Enrollment (expected or actual): 151
Allocation:
Sponsor: University of Vermont
Principal Investigator: Tom Fontana, Alcohol, Cannabis & Other Drugs Initiatives Manager
Completion Date (primary or actual): July 1, 2021
The Use of Cannabidiol in Cancer Patients
Alternative and complementary medicines (MAC) are commonly used by cancer patients to help them to face with anticancer treatment, reduce oncology symptoms and/or anticancer treatment adverse effects, detoxifying the body. In consistence with guidelines from the French Society for Oncology Pharmacy (SFPO), the pharmaceutical consultation includes a discussion and collection of herbs, botanical and other natural products consumed by cancer patients. This aim to prevent and manage herb-drug interaction as well as other drug-related problems (DRP). The recent French experimentation dedicated to cannabidiol for medical use could enhance interest of cancer patients in the field of MAC. However, cannabidiol have shown inhibitory effect on different cytochromes with a risk of HDI as other MAC. While the prevalence of MAC consumption is already known in some type of cancer, the consumption of CBD is less known and should be explored. Through this study we wish to know the prevalence of cannabidiol consumption in cancer patients and to establish a typical profile as well as to know the modalities of use. We also want to validate a questionnaire through a literacy scale.
First Posted: June 7, 2022
Condition(s): Cancer
Intervention(s): Non applicable
Status: Completed
Enrollment (expected or actual): 350
Allocation:
Sponsor: CHU de Reims
Principal Investigator:
Completion Date (primary or actual): December 31, 2021
Warrior CARE: Naturalistic Observation and Harm Reduction
This study is looking at therapeutic potential of reducing Tetrahydrocannabinol (THC) levels in regular cannabis smokers using contingency management (CM) intervention in a U.S. veteran population with post-traumatic stress disorder (PTSD).
First Posted: May 23, 2022
Condition(s): Post Traumatic Stress Disorder, Cannabis Use, Suicide
Intervention(s): Reduce THC Use
Status: Recruiting
Enrollment (expected or actual): 215
Allocation: Non-Randomized
Sponsor: Wayne State University
Principal Investigator: Leslie Lundahl, Associate Professor
Completion Date (primary or actual): December 31, 2026
Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain
Veterans with diabetes are more likely than diabetic civilians to develop disabling chronic diabetic neuropathic pain (CDNP). Research on frontline treatments for CDNP (enhanced glycemic control, exercise, pharmacological agents), shows inconsistent outcomes and dissatisfaction among Veterans. Veterans and clinicians have shown significant interest in cannabis derivatives (THC, CBD) for neuropathic pain control, but there are no well-controlled trials guiding expectations for benefit and adverse outcomes associated with cannabis for CDNP. Because Veterans are likely to present with pain and pain-related polymorbidity significantly differing from that of civilians, a well-structured clinical trial of cannabinoids for Veterans with CDNP is vital.
The present phase II study will offer the first evidence describing the potential benefits and adverse effects of cannabinoids for CDNP in Veterans using a four-arm, double-blind, multisite randomized trial comparing THC, CBD, THC+CBD and placebo on neuropathic pain outcomes.
First Posted: April 28, 2022
Condition(s): Diabetic Neuropathic Pain
Intervention(s): THC (Dronabinol), CBD (Epidolex), THC + CBD (Nabiximols), Placebo
Status: Not yet recruiting
Enrollment (expected or actual): 320
Allocation: Randomized
Sponsor: VA Office of Research and Development
Principal Investigator:
Completion Date (primary or actual): June 30, 2027
Oral Cannabidiol Effect on Blood Pressure in Hypertensive Patients
The objective of this randomized, placebo-controlled and crossover study is to extend the findings from the acute studies into more chronic administration of CBD in individuals with mild or moderate hypertension who are either untreated or receiving standard care therapy. The hypothesis is that the hypotensive effects of CBD will be apparent in both untreated and treated hypertension and reflected in improved vascular biomarkers and psychological well-being.
First Posted: April 26, 2022
Condition(s): Hypertension
Intervention(s): Cannabidiol, Placebo
Status: Active, not recruiting
Enrollment (expected or actual): 70
Allocation: Randomized
Sponsor: University of Split, School of Medicine
Principal Investigator: Zeljko Dujic, Professor
Completion Date (primary or actual): October 5, 2022
Project e-PBI+ - Parent Intervention to Reduce College Student Drinking and Cannabis Use
College students' risky drinking and cannabis use are major public health problems. The harms associated with risky drinking have been well-documented (such as deaths, blackouts, injuries, assaults, arrests, sexual consequences, academic consequences). Both college health administrators and parents have requested electronic parent-based interventions (e-PBIs) with additional content on cannabis. Parents have demonstrated ample motivation to communicate with their teens. The proposed research will attempt to enhance an existing effective e-PBI, curb the alarming trends noted in the literature, and move the field forward by conducting a randomized controlled trial testing a modified version of the e-PBI that includes updated content including the most up-to-date scientific information from cannabis studies (e-PBI+).
First Posted: April 26, 2022
Condition(s): Underage Drinking, Cannabis Use, Drinking, Teen, Drinking, College, College Drinking, Teen Drinking
Intervention(s): e-PBI+, e-PBI
Status: Not yet recruiting
Enrollment (expected or actual): 2425
Allocation: Randomized
Sponsor: Penn State University
Principal Investigator: Robert Turrisi, Professor of Biobehavioral Health
Completion Date (primary or actual): July 2026
Cannabis for Chronic Headaches in Adolescents: the CAN-CHA Trial
Chronic headaches are a major cause of disability among adolescents. Cannabis products have supported the management of headaches in adults and may play a role in pediatric chronic pain. We propose a multisite, open-label, tolerability study conducted across three centers in Canada of Cannabidiol-enriched Cannabis Herbal Extract in adolescents (ages 14 to 17 years old) with chronic headaches. The study includes a one month baseline assessment, four months of escalating treatment doses and a weaning period. Our primary outcome is tolerability defined as the number and severity of reported adverse events.
First Posted: April 20, 2022
Condition(s): Chronic Migraine
Intervention(s): MPL-001
Status: Not yet recruiting
Enrollment (expected or actual): 20
Allocation: N/A
Sponsor: University of Manitoba
Principal Investigator: Lauren Kelly, Lauren E Kelly PhD, MSc, BMedSci, CCRP, Assistant Professor, Dept. of Pediatrics & Child Health, University of Manitoba Scientific Director, Canadian Childhood Cannabinoid Clinical Trials (www.C4Trials.org)
Completion Date (primary or actual): December 31, 2025
Dronabinol After Arthroscopic Surgery
The purpose of the proposed study is to evaluate the efficacy of dronabinol for postoperative pain after arthroscopic surgery of the knee. The investigators hypothesize that dronabinol will relieve pain, reduce opioid consumption and will result in few negative side effects. If this pilot study shows promising results the investigators will expand the trial to include additional arthroscopic surgeries (hip, shoulder) and other types of orthopaedic surgery.
First Posted: April 19, 2022
Condition(s): Knee Osteoarthritis, Knee Injuries, Meniscus Tear, Synovitis of Knee, Knee Ligament Injury, Chondral Injury of Left Knee, Chondral Injury of Right Knee, Loose Body Knee
Intervention(s): Dronabinol, Placebo
Status: Recruiting
Enrollment (expected or actual): 30
Allocation: Randomized
Sponsor: Northwestern University
Principal Investigator: Vehniah Tjong, Assistant Professor
Completion Date (primary or actual): February 2023
CanCope: Digital Intervention for Coping With Cannabis Craving
The CanCope Study is a micro-randomized trial conducted to gather evidence about and compare the effectiveness of a momentary intervention to help young adults cope with cannabis cravings as they attempt to reduce their use.
First Posted: April 14, 2022
Condition(s): Cannabis Use
Intervention(s): CanCope
Status: Completed
Enrollment (expected or actual): 55
Allocation: Randomized
Sponsor: Trustees of Dartmouth College
Principal Investigator:
Completion Date (primary or actual): December 16, 2021
Effect of AEF0117 on Treatment-seeking Patients With Cannabis Use Disorder (CUD): SICA 2: SPECIFIC SIGNALING INHIBITOR IN CANNABIS ADDICTION
Cannabis use is increasing and will only further escalate with legalization of recreational and medical cannabis use in western countries , with a prevalence greater than 30 % in the US and most European countries for individuals between 16 and 24 years of age. Approximately 9 % of those who use cannabis will become addicted. The number goes up to about 1 in 6 among those who start using cannabis as teenagers and to 25 to 50 % among those who smoke cannabis daily. The consequences of cannabis abuse in the most prone population (14-25 years of age) are extremely serious, and may include addiction, altered brain development, poorer educational outcomes, cognitive impairment, lower income, greater welfare dependence, unemployment and lower relationship and life satisfaction. There are no available pharmacological treatments of cannabis use disorder (CUD). Thus, the development of safe and effective medications for the treatment of CUD is an urgent public health priority.
The preclinical efficacy and available ADMET (Administration, Distribution, Metabolism, Elimination and Toxicology) in animal and human data suggest that AEF0117, an investigational new study drug, could constitute a very efficacious and safe treatment for cannabis abuse disorders. The purpose of this research is to study how AEF0117 influences the subjective effects of cannabis in subjects with CUD. AEF0117 acts in the same parts of the brain as THC (tetrahydrocannabinol), the active ingredient of marijuana, and may temporarily alter some of cannabis's effects.
The safety and tolerability of AE0117 has been demonstrated in the clinical studies conducted to date. This study will provide additional data on the efficacy of AEF0117 on treatment-seeking subjects with moderate to severe CUD.
This is a phase 2b, randomized, double-blind, placebo-controlled, 4-arm, parallel-group, prospective, multicenter study. The overall purpose of this study is to assess the efficacy and safety of AEF0117 in subjects with moderate to severe CUD who are treatment-seeking. The primary objective of this study is to demonstrate that AEF0117 induces a greater proportion of RESPONDERS (i.e., subjects with a RESPONSE of ≤1 day of cannabis use per week) compared to placebo in treatment-seeking subjects with moderate to severe CUD, according to DSM-5 criteria.The secondary objectives are to investigate the proportion of subjects that reach various levels of reduction and how this influences their quality of life, and to evaluate the safety and tolerability of AEF0117. And the exploratory objectives of this study are to further evaluate the effect of AEF0117 on pattern of cannabis use and change in various signs and symptoms, and in addition to assess effects during the grace period and the entire treatment period.
First Posted: April 12, 2022
Condition(s): Marijuana Abuse
Intervention(s): AEF0117, Placebo oral capsule
Status: Recruiting
Enrollment (expected or actual): 330
Allocation: Randomized
Sponsor: Aelis Farma
Principal Investigator:
Completion Date (primary or actual): August 2023
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