Combining Varenicline and Naltrexone for Smoking Cessation
NCT02698215 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 165
Last updated 2021-06-15
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.
Conditions
- Nicotine Dependence
- Alcohol Use Disorder
Interventions
- DRUG
-
Varenicline
Varenicline 1 mg twice daily
- DRUG
-
Varenicline plus Naltrexone
Varenicline 1 mg twice daily plus Naltrexone 50 mg once daily
Sponsors & Collaborators
-
National Institute on Drug Abuse (NIDA)
collaborator NIH -
University of California, Los Angeles
lead OTHER
Principal Investigators
-
Lara Ray, PhD · University of California, Los Angeles
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-05-31
- Primary Completion
- 2019-12-31
- Completion
- 2019-12-31
Countries
- United States
Study Locations
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