UH3 Varenicline for Cannabis Use Disorder

Phase 2

Completed

• Conditions: Cannabis Use Disorder
• Interventions: Drug: Placebo; Drug: Varenicline

• Registration Number: NCT03980561
• Lead Sponsor: Medical University of South Carolina

Brief Summary

Marijuana is the most commonly used illicit drug. There is high demand for effective interventions for cannabis use disorder, yet few specific treatments for have been developed. This study will evaluate the efficacy of varenicline for reducing marijuana use in people who use marijuana frequently.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-06
• Study First Submitted QC: 2019-06-07
• Study First Posted: 2019-06-10
• Study Start: 2020-01-31
• Primary Completion: 2023-02-09
• Status Verified: 2023-12
• Study Completion: 2023-12-01
• Results First Submitted: 2023-12-21
• Results First Submitted QC: 2023-12-21
• Last Update Submitted: 2023-12-21
• Results First Posted: 2024-01-18
• Last Update Posted: 2024-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

• Must meet DSM-5 criteria for cannabis use disorder and use cannabis at least 3 days per week in the last 30 days.
• Express interest in receiving treatment for cannabis use disorder and reducing use.
• Must be at least 18 years of age.
• If female and of childbearing potential, must agree to use acceptable methods of birth control for the duration of the trial.
• Must consent to random assignment, and be willing to commit to medication ingestion.
• Must be able to read and provide informed consent.
• Must have body weight >110lbs (50kg) and have BMI between 18 and 35kg/m2
• Must function at an intellectual level and have knowledge of the English language to sufficiently allow for accurate completion of assessments.

Exclusion Criteria

• Women who are pregnant, nursing, or plan to become pregnant during the course of the study.
• Individuals with severe renal impairment (creatinine clearance less than 30 mL per minute).
• Lifetime history of DSM-5 Bipolar I or II Disorder, Schizophrenia or other psychotic disorder. Stably treated MDD, Dysthymia, GAD, Social Phobia, and Specific Phobia diagnoses are acceptable (i.e. same dose of medication has been prescribed for at least 2 months prior to screening and no changes in current medication expected during course of the trial).
• Past year or current posttraumatic stress disorder.
• Subjects who are actively suicidal, or who report suicidal ideation (SI) with intent or plan in the past year.
• Subjects who have a SBQ R total score ≥8, or for whom the investigator judges that a risk assessment by a qualified medical professional is required. Subjects answering 'yes' on questions 4 or 5 of C-SSRS will be referred to assessment by a qualified mental health professional.
• Suicidal behavior within the past 10 years or a lifetime history of serious or recurrent suicidal behavior.
• Concomitant use of psychotropic medications, with the exception of stable doses (defined as no dosing adjustments in the past two months) of non-MAO-I antidepressants, non-benzodiazepine anxiolytics, and ADHD medications.
• Current use of medications prescribed for mania or psychosis.
• Current use of buproprion or nortryptiline.
• Moderate or severe non-cannabis substance use disorders within the past 60 days with the exception of tobacco use disorder.
• Past year or current moderate or severe alcohol use disorder.
• Individuals taking an investigational agent within the last 30 days before baseline visit.
• Individuals with clinically significant medical disorders or lab abnormalities.
• Any individual at screening with SGOT (AST) or SGPT (ALT) greater than 3 times the upper limit of normal and/or total bilirubin greater than two times the upper limit of normal.
• Individuals with clinically significant cardiovascular disease in the past 6 months (e.g., myocardial infarction, CABG, PTCA, severe or unstable angina, serious arrhythmia, or any clinically significant ECG conduction abnormality.
• Individuals with clinically significant cerebrovascular disease in the past 6 months such as TIA, CVA, or stroke.
• Hypersensitivity to varenicline.
• Individuals who have participated in the clinical trial of any investigative compound within the last 60 days
• Individuals who are on probation or under a mandate to obtain treatment.
• Individuals with plans to initiate or change frequency of attendance at self-help meetings (e.g. AA, NA).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	2 mg daily
Varenicline	Varenicline	2 mg daily

Primary Outcome Measures

Name	Time	Method
Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions	Treatment phase Weeks 6-12	Cannabis use reduction was measured by daily substance use logs/self-report and examined as the total number of use sessions reported at each weekly visit.

Secondary Outcome Measures

Name	Time	Method
Safety and Tolerability of Varenicline vs. Placebo When Used for Cannabis Use Disorder	12 weeks (across the active treatment period)	Comparing the frequency of participant-reported treatment-emergent AEs between treatment groups. Of particular interest will be AEs leading to medication discontinuation and the occurrence of treatment-related serious AEs.

Trial Locations

Locations (2)

Behavioral Health Services of Pickens County; 🇺🇸 Pickens, South Carolina, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States