Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Lobeline; Nicotine

Criteria

Inclusion Criteria:

• 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.