CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 81 enrolled
Drug / intervention
nicotine lozenges +1 moredrug
Likely dose
nicotine lozenges 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.

Search/NCT01018394
NCT01018394Phase 3Completed

A Pilot Study to Compare the Nicotine Lozenge and Tobacco-Free Snuff for Smokeless Tobacco Reduction

Mayo Clinic·interventional·Posted Nov 23, 2009·Updated Sep 13, 2013

In Brief

A Phase 3 clinical trial evaluating nicotine lozenges and tobacco-free snuff for Tobacco Dependence. Completed, enrolled 81 participants across 2 sites.

Detailed Summary

Smokeless tobacco (ST) is a known human carcinogen. Long-term ST use is known to increase the risk for oropharyngeal cancer. Extant literature on cigarette smokers suggests that smoking reduction increases smoking abstinence among smokers not interested in quitting. The overarching goal of this line of research is to develop a ST reduction intervention among ST users not interested in quitting tobacco. Our first step is to conduct the proposed pilot study designed to assess the efficacy of the nicotine lozenges or tobacco-free snuff for reducing ST use or facilitating ST abstinence among ST users not interested in quitting.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 23, 2009
Enrollment StartJan 1, 2009
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 16.6 years ago

Interventions

nicotine lozengesdrug

4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day.

tobacco-free snuffdrug

Tobacco-free snuff used ad lib for a maximum of 12 weeks