NCT00888459

A Pilot Study Evaluating Nicotine Lozenges and Self Help

A Pilot Study to Assess the Effectiveness of the Nicotine Lozenge for Smokeless Tobacco Users

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Smokeless Tobacco Use

Interventions

Type	Name	Description
DRUG	nicotine replacement therapy	4 mg nicotine lozenges, ad lib, for 12 weeks.
DRUG	placebo NRT	Placebo nicotine lozenges

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-04-01
• Completion: 2009-05-01
• First posted: 2009-04-27
• Last updated: 2023-10-23
• Results posted: 2010-11-04

Locations

2 sites across 1 country: United States