Conditions: Smokeless Tobacco Use
Keywords: tobacco chew nrt nicotine lozenges self-help
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 60
Healthy volunteers: yes

Brief summary:
The investigators are hypothesizing that by offering both self-help materials and mailed nicotine lozenges we will be able to help increase tobacco abstinence rates among ST users, as well as decrease tobacco withdrawal.

Detailed description:
Smokeless tobacco (ST) is a known human carcinogen. Long-term ST use is known to increase the risk for oropharyngeal cancer. Most smokeless tobacco users wish to quit. Assisted-self help interventions (i.e., self-help manual, a targeted video, and two support telephone phone calls) have been shown to be superior to manual-only interventions for increasing tobacco abstinence rates. These interventions lend themselves to widespread dissemination, but abstinence rates at 6 months remains low (21%). Providing nicotine replacement therapy (NRT) to ST users receiving assisted self-help interventions could improve upon these ST abstinence rates. If found to be effective, this intervention may increase the ability to disseminate effective interventions to a population of tobacco users for whom few treatment resources currently exist.

Arms:
arm 1: Self-help counseling material and 4 mg nicotine lozenges arm 2: self help counseling material and placebo nicotine lozenges

Interventions: intervention 1: nicotine replacement therapy intervention 2: placebo NRT
Intervention descriptions: intervention 1: 4 mg nicotine lozenges, ad lib, for 12 weeks. intervention 2: Placebo nicotine lozenges

Protocol document: