At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 60 enrolled
Drug / intervention
nicotine replacement therapy +1 moredrug
Likely dose
nicotine replacement therapy 4 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.
A Pilot Study to Assess the Effectiveness of the Nicotine Lozenge for Smokeless Tobacco Users
In Brief
A Phase 2 clinical trial evaluating nicotine replacement therapy and placebo NRT for Smokeless Tobacco Use. Completed, enrolled 60 participants across 2 sites.
Detailed Summary
The investigators are hypothesizing that by offering both self-help materials and mailed nicotine lozenges we will be able to help increase tobacco abstinence rates among ST users, as well as decrease tobacco withdrawal.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmokeless Tobacco Use
CountriesUnited States
CollaboratorsOregon Research Institute
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2008
Primary CompletionApr 2009
First PostedApr 2009
Study CompletionMay 2009
TodayJul 2026
First PostedApr 27, 2009
Enrollment StartApr 1, 2008
Primary CompletionApr 1, 2009
Study CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 17.2 years ago
Interventions
nicotine replacement therapydrug
4 mg nicotine lozenges, ad lib, for 12 weeks.
placebo NRTdrug
Placebo nicotine lozenges