NCT04595318

Varenicline for Co-occurring Cannabis and Tobacco Use

Feasibility and Preliminary Effectiveness of Varenicline for Co-occurring Cannabis and Tobacco Use

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Albert Einstein College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Pilot, eight week, open-label, within-subject cross over trial of four weeks of standard clinical care (SCC) in an outpatient substance use disorder treatment program and four weeks of SCC and varenicline among current and former tobacco smokers with frequent cannabis use.

Detailed description

Treating co-occurring cannabis and tobacco use disorders might reduce the health burdens associated with both substances. However, few studies have evaluated pharmacological interventions, in combination with behavioral treatment, to address co-occurring cannabis and tobacco use; these are limited by high participant attrition, poor adherence to interventions, and lack of control. Pilot, eight week, open-label, within-subject cross over trial of four weeks of standard clinical care (SCC) in an outpatient substance use disorder treatment program and four weeks of SCC and varenicline among current and former tobacco smokers with frequent cannabis use. Participants were recruited from an urban, outpatient substance use disorder treatment program that offers both intensive behavioral counseling and medications for opioid use disorder (MOUD). Participants were randomized to receive either SCC or SCC and varenicline first and then were crossed over to receive the opposite intervention. The study consisted of two 4-week treatment periods with no washout period. Outcomes are reported in pooled analyses of all participants in each treatment phase.

Conditions

• Cannabis Dependence
• Tobacco Dependence

Interventions

Type	Name	Description
DRUG	Standard clinical care first, followed by standard clinical care and varenicline	Standard clinical care includes substance use disorder treatment program-based individual behavioral counseling at least once a month using motivational and cognitive behavioral strategies. Varenicline therapy includes a one month's supply of the medication in standard doses: 0.5 mg for 3 days, 0.5 mg twice a day for 4 days, then 1 mg twice a day for 21 days.
DRUG	Standard clinical care and varenicline first, followed by standard clinical care	Standard clinical care includes substance use disorder treatment program-based individual behavioral counseling at least once a month using motivational and cognitive behavioral strategies. Varenicline therapy includes a one month's supply of the medication in standard doses: 0.5 mg for 3 days, 0.5 mg twice a day for 4 days, then 1 mg twice a day for 21 days.

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2020-10-20
• Last updated: 2024-09-24
• Results posted: 2024-09-24

Regulatory

• FDA-regulated drug study