Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction

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

Outcome

Met primary endpoint

registry analysis (superiority or other test); Nicotine Lozenge vs Placebo Nicotine Lozenge; p <0.05; Odds Ratio (OR) 3; Regression, Logistic; note: No adjustment for multiple comparisons. NCT00392379 ↗

Drugs

Indications

No indication recorded.