At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 52 enrolled
Drug / intervention
nicotine replacement therapy (nicotine patches) +1 moredrug
Likely dose
nicotine replacement therapy (nicotine patches) 21 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.
Highdose Nicotine Patch Therapy for Smokeless Tobacco Use
In Brief
A Phase 3 clinical trial evaluating nicotine replacement therapy (nicotine patches) and placebo NRT for Smokeless Tobacco Use. Completed, enrolled 52 participants across 1 site.
Detailed Summary
Smokeless tobacco use ("chewing") is associated with negative health effects. To date, no medications have been shown to help chewers quit long-term. High dose nicotine patch therapy may improve the chances that chewers can quit for good. If found to be effective, chewers may use this treatment to help them quit and reduce their risk for negative health effects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmokeless Tobacco Use
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 2009
Enrollment StartJul 2010
Primary CompletionJun 2013
TodayJul 2026
First PostedJul 14, 2009
Enrollment StartJul 1, 2010
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 17.0 years ago
Interventions
nicotine replacement therapy (nicotine patches)drug
2- 21 mg patches per day for 8 weeks
placebo NRTdrug
2 placebo patches (containing no active ingredient)per day for 8 weeks