drugset / Trial / NCT01341938

Nicotine Lozenges and Assisted Self-help for Smokeless Tobacco Cessation

NCT01341938

RandomizedParallel-groupSingle-blindTreatment

Summary

This research study will determine if using a combination of 4-mg nicotine lozenges, self-help materials, and/or telephone tobacco cessation counseling will help smokeless tobacco users stop using tobacco. The study will consist of three interventions: 1. The Lozenge Assisted Self-help intervention - lozenge nicotine replacement therapy, phone counseling, and self help materials 2. Assisted Self-Help intervention - self-help materials and phone counseling without lozenges 3. Lozenge Self Help intervention - self help materials and lozenge nicotine replacement therapy. Hypothesis: The Lozenge Assisted Self-help intervention will significantly increase both the prolonged and point prevalence for all tobacco and smokeless tobacco (ST) abstinence rates at 6 months among ST users who are interested in achieving tobacco abstinence, compared to those in the Assisted Self-Help intervention and the Lozenge Self Help intervention.

Timeline

Start
2011-07
Primary completion
2012-11
Completion
2012-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Nicotine Unknown 4 mg

Indications

No indication recorded.