CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
naltrexone +2 moredrug
Likely dose
naltrexone 25 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/NCT00773422
NCT00773422Phase 2Completed
CompareCT.gov

The Effect of Naltrexone and Varenicline on Alcohol-Mediated Smoking Lapse

Yale University·interventional·Posted Oct 16, 2008·Updated Apr 23, 2018

In Brief

A Phase 2 clinical trial evaluating naltrexone, varenicline, and 1 other intervention for Smoking. Completed, enrolled 30 participants across 1 site.

Detailed Summary

The purpose of this study is to examine how medications thought to attenuate the effects of alcohol (naltrexone) and smoking cessation medications (varenicline) affect the ability to resist smoking and also subsequent ad-lib smoking, following a low-dose alcohol priming drink, in non-treatment seeking alcohol-drinking daily smokers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking
CountriesUnited States
CollaboratorsNational Institute on Alcohol Abuse and Alcoholism (NIAAA)

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 16, 2008
Enrollment StartJan 1, 2008
Primary CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 8.8 yearsPosted 17.7 years ago

Interventions

naltrexonedrug

25 mg/day, with 1-week lead-in medication period. The starting dose is 0 mg/day for days 1-3, followed by 12.5mg/day for day 4, followed by 25mg/day for days 5-7, plus during the laboratory session (day 8).

vareniclinedrug

2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8).

placebodrug

placebo