At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 110 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.
An Experimental Medicine, Randomized, Double-Blind Study Assessing Neuropsychiatric Symptoms In Quitting Smokers Treated With Varenicline Tartrate Or Placebo
In Brief
A Phase 4 clinical trial evaluating varenicline and placebo for Smoking Cessation. Completed, enrolled 110 participants across 2 sites.
Detailed Summary
Study objective is to compare neuropsychiatric adverse events in subjects treated with varenicline or placebo in a controlled setting where both groups are experiencing nicotine withdrawal.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking Cessation
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2008
First PostedSep 2008
Primary CompletionJul 2009
Study CompletionAug 2009
TodayJul 2026
First PostedSep 10, 2008
Enrollment StartSep 1, 2008
Primary CompletionJul 1, 2009
Study CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 17.8 years ago
Interventions
vareniclinedrug
1 mg tablets twice daily by mouth (after one week of uptitration: 0.5mg once daily for three days, 0.5mg twice daily for four days)
placebodrug
1 mg tablets twice daily by mouth (after one week of uptitration: 0.5mg once daily for three days, 0.5mg twice daily for four days)