At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 446 enrolled
Drug / intervention
Varenicline, Nicotine Patch +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.
A 26-Week Phase II, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Varenicline in Combination With Nicotine Replacement Therapy for Smoking Cessation
In Brief
A Phase 2 clinical trial evaluating Varenicline, Nicotine Patch and Varenicline and Placebo Patch for Tobacco Dependence. Completed, enrolled 446 participants across 7 sites.
Detailed Summary
The purpose of this study is to test whether the addition of a nicotine patch to varenicline increases smoking cessation success rate and whether the combination is safe.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTobacco Dependence
CountriesSouth Africa
CollaboratorsQuitSupport
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2011
First PostedSep 2011
Primary CompletionApr 2013
Study CompletionJun 2013
TodayJul 2026
First PostedSep 30, 2011
Enrollment StartApr 1, 2011
Primary CompletionApr 1, 2013
Study CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 14.8 years ago
Interventions
Varenicline, Nicotine Patchdrug
active nicotine patches added to varenicline.
Varenicline and Placebo Patchdrug
placebo nicotine patches added to varenicline.