CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 270 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/NCT00392379
NCT00392379Phase 3Completed
CompareCT.gov

Evaluating Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction

Mayo Clinic·interventional·Posted Oct 26, 2006·Updated Apr 24, 2013

In Brief

A Phase 3 clinical trial evaluating Nicotine Lozenges and Placebo lozenge for Smokeless Tobacco Use. Completed, enrolled 270 participants across 2 sites.

Detailed Summary

This study will be a randomized, blinded, placebo-controlled two-group clinical trial. The independent variable is treatment assignment (active 4-mg nicotine lozenge vs. matching placebo lozenge), and the dependent variables are all tobacco and ST abstinence at 3 and 6 months. ST users will be randomly assigned to either the 4-mg active nicotine lozenge or matching placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmokeless Tobacco Use
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 26, 2006
Enrollment StartJan 1, 2007
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 19.7 years ago

Interventions

Nicotine Lozengesdrug

Nicotine lozenges, 4 mg

Placebo lozengedrug

Placebo lozenge