Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction

Phase 3 Completed 270 enrolled Mayo Clinic National Cancer Institute (NCI) · collab

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2007-01
Primary completion: 2009-03
Completion: 2009-03

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nicotine	Unknown	4 mg	—

Indications

No indication recorded.