Varenicline Treatment for Cannabis Use Disorder

Phase 2

Completed

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

• Registration Number: NCT02892110
• 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: 2016-08-30
• Study First Submitted QC: 2016-09-01
• Study First Posted: 2016-09-08
• Study Start: 2017-02-13
• Primary Completion: 2018-11-08
• Study Completion: 2018-11-27
• Status Verified: 2019-10
• Results First Submitted: 2019-10-22
• Results First Submitted QC: 2019-11-13
• Last Update Submitted: 2019-11-13
• Results First Posted: 2019-12-03
• Last Update Posted: 2019-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

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
Cannabis Withdrawal Symptoms During Active Treatment	3 weeks (Week 4-6 of active treatment period)	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).

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Cannabis Abstinence	3 weeks (Week 4-6 of active treatment period)	Self reported abstinence from Timeline Followback, verified by urine cannabinoid measures
Cannabis Use Quantity	3 weeks (Week 4-6 of active treatment period)	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.

Trial Locations

Locations (1)

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