At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 104 enrolled
Drug / intervention
Varenicline +1 moredrug
Likely dose
Not stated in 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.
Relapse Prevention With Varenicline
In Brief
A Phase 4 clinical trial evaluating Varenicline and Placebo for Recurrence and 2 related conditions. Completed, enrolled 104 participants across 1 site.
Detailed Summary
This study aims to determine if varenicline (Chantix®), currently used as a smoking cessation aid, will decrease the likelihood of relapse to smoking following a programmed lapse in the laboratory. The hypothesis is that varenicline will reduce the reinforcing effects of smoking and will delay or prevent relapse compared to placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrence, Smoking Cessation, Substance-Related Disorders
CountriesUnited States
CollaboratorsPfizer
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2008
First PostedJul 2009
Primary CompletionMay 2011
TodayJul 2026
First PostedJul 23, 2009
Enrollment StartOct 1, 2008
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 16.9 years ago
Interventions
Vareniclinedrug
Varenicline given twice a day or five weeks.
Placebodrug
Placebo given twice a day or five weeks.