Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction

Completed · Phase 3 · Has a placebo group

Conditions studied: Smokeless Tobacco Use

In brief

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.

Key facts

Study ID

NCT00392379

Run by

Mayo Clinic

People needed

270

Starts

2007-01-01

Expected to finish

2009-03-01

Last updated by the study team

2013-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• are at least 18 years of age;
• report smokeless tobacco (ST) as their primary tobacco of use;
• have used ST daily for the past 6 months;
• are in general good health (determined by medical history and screening physical examination);
• have been provided with, understand, and have signed the informed consent.

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States
• Oregon Research Institute — Eugene, Oregon, United States

Full record on ClinicalTrials.gov

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