UH3 Varenicline for Cannabis Use Disorder

Varenicline for the Treatment of DSM 5 Cannabis Use Disorder in Adults

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.

Study Overview

• Status: Completed
• Conditions: Cannabis Use Disorder
• Intervention / Treatment: Drug: Varenicline; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 174
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Pickens, South Carolina, United States, 29671
      • Behavioral Health Services of Pickens County

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Varenicline; 2 mg daily	Drug: Varenicline; Active medication; Other Names: Chantix, Apo-Varenicline
Placebo Comparator: Placebo; 2 mg daily	Drug: Placebo; Inactive medication; Other Names: Sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions	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.	Treatment phase Weeks 6-12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability of Varenicline vs. Placebo When Used for Cannabis Use Disorder	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.	12 weeks (across the active treatment period)

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Aimee McRae-Clark, PharmD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2020
• Primary Completion (Actual): February 9, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: June 6, 2019
• First Submitted That Met QC Criteria: June 7, 2019
• First Posted (Actual): June 10, 2019

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: marijuana; substance use
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Marijuana Abuse; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: PRO00089933

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No