NCT02698215

Combining Varenicline and Naltrexone for Smoking Cessation

Combining Varenicline and Naltrexone for Smoking Cessation and Drinking Reduction

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is a double-blind, randomized clinical trial using a two group medication design consisting of the combination of VAR (1 mg twice daily) + NTX (50 mg once daily) and VAR (1 mg twice daily) + PLA (matched to NTX), for smoking cessation in a sample of heavy drinking daily smokers who want to quit smoking and reduce drinking.

Detailed description

This study is a double-blind, randomized clinical trial using a two group medication design consisting of the combination of VAR (1 mg twice daily) + NTX (50 mg once daily) and VAR (1 mg twice daily) + PLA (matched to NTX), for smoking cessation in a sample of heavy drinking daily smokers who want to quit smoking and reduce drinking. All participants will be daily smokers (≥ 5 cig/day) who are also heavy drinkers according to the National Institute on Alcohol Abuse and Alcoholism (NIAAA) guidelines: for men, \> 14 drinks per week or ≥ 5 drinks per occasion at least once per month over the past 12 months; for women, \> 7 drinks per week or ≥ 4 drinks per occasion at least once per month over the past 12 months. A total of 274 participants will be randomized, 137 to each medication group.

Conditions

• Nicotine Dependence
• Alcohol Use Disorder

Interventions

Type	Name	Description
DRUG	Varenicline	Varenicline 1 mg twice daily
DRUG	Varenicline plus Naltrexone	Varenicline 1 mg twice daily plus Naltrexone 50 mg once daily

Timeline

• Start date: 2016-05-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2016-03-03
• Last updated: 2021-06-15
• Results posted: 2021-06-15

Locations

1 site across 1 country: United States