CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 165 enrolled
Drug / intervention
Varenicline +1 moredrug
Likely dose
Varenicline 1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02698215
NCT02698215Phase 2Completed
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Combining Varenicline and Naltrexone for Smoking Cessation and Drinking Reduction

University of California, Los Angeles·interventional·Posted Mar 3, 2016·Updated Jun 15, 2021

In Brief

A Phase 2 clinical trial evaluating Varenicline and Varenicline plus Naltrexone for Nicotine Dependence and Alcohol Use Disorder. Completed, enrolled 165 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNicotine Dependence, Alcohol Use Disorder
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 3, 2016
Enrollment StartMay 1, 2016
Primary CompletionDec 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 10.3 years ago

Interventions

Vareniclinedrug

Varenicline 1 mg twice daily

Varenicline plus Naltrexonedrug

Varenicline 1 mg twice daily plus Naltrexone 50 mg once daily