Varenicline Treatment for Cannabis Use Disorder

Advancing Varenicline as a Treatment for Cannabis Use Disorder

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: Substance Use Disorder
• Intervention / Treatment: Drug: Varenicline; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

General 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.
• Must be between the ages of 18 and 65 years.
• 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.

Additional Inclusion Criteria for fMRI Eligibility

• Must be right-handed.

General 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).
• Suicidal ideation or behavior within the past 6 months. Subjects who are believed to be at suicidal or homicidal risk (answers 'yes' on questions 4 or 5 of C-SSRS) will be referred for assessment by a qualified mental health professional.
• 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.
• 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.

Additional Exclusion Criteria for fMRI Eligibility

• Any psychiatric or medical issues, including claustrophobia, ferrous metal implants, pacemakers, or other electronic devices that would interfere with ability to participate in and successfully complete scanning procedures.
• Any person unable to lie still within the fMRI scanner for the required period of time to obtain useful images (use of anxiolytics will not be permitted for anxiety/claustrophobia related to scanning procedures).

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; 2 mg daily; Other Names: Chantix
Placebo Comparator: Placebo; 2 mg daily	Drug: Placebo; 2 mg daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cannabis Withdrawal Symptoms During Active Treatment	For this outcome, the negative affect subscale items of The Cannabis Withdrawal Scale (items 5 ["I felt nervous], 6 ["I had some angry outbursts"], 7 ["I had mood swings"], 8 ["I felt depressed"], 9 ["I was easily irritated"], 15 ["Life seemed an uphill struggle"], 18 ["I felt physically tense"], restlessness (item 11, "I felt restless), and/or urge to smoke (items 1 and 10, "The only thing I could think about was smoking some cannabis" and "I had been imagining being stoned") were averaged at Weeks 4, 5, and 6 and for an overall 4-6 week value, with minimum score of the subscale being 0 and maximum score being 100 (higher score indicating worse outcome).	3 weeks (Week 4-6 of active treatment period)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Cannabis Abstinence	Self reported abstinence from Timeline Followback, verified by urine cannabinoid measures	3 weeks (Week 4-6 of active treatment period)
Cannabis Use Quantity	Cannabis use sessions per day measured by Timeline Followback (self-report) at twice weekly visits during Weeks 4, 5 and 6 of the active treatment phase.	3 weeks (Week 4-6 of active treatment period)

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2017
• Primary Completion (Actual): November 8, 2018
• Study Completion (Actual): November 27, 2018

Study Registration Dates

• First Submitted: August 30, 2016
• First Submitted That Met QC Criteria: September 1, 2016
• First Posted (Estimate): September 8, 2016

Study Record Updates

• Last Update Posted (Actual): December 3, 2019
• Last Update Submitted That Met QC Criteria: November 13, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Motivational enhancement therapy; Marijuana use; Varenicline/Chantix
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: Pro00058198; UG3DA043231 (U.S. NIH Grant/Contract)

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