CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Naltrexone +1 moredrug
Likely dose
Naltrexone 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/NCT00502216
NCT00502216Phase 2Completed

Naltrexone and Varenicline: Weight Gain and Tolerability in Smokers

Yale University·interventional·Posted Jul 17, 2007·Updated Jan 17, 2018

In Brief

A Phase 2 clinical trial evaluating Naltrexone and Varenicline for Smoking and Nicotine Dependence. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether the combination of naltrexone (Depade) and varenicline (Chantix) minimizes post-smoking cessation weight gain and how well the combination is tolerated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 17, 2007
Enrollment StartJul 1, 2007
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 19.0 years ago

Interventions

Naltrexonedrug

Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day

Vareniclinedrug

Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day; Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day