NCT01018394

Nicotine Lozenge or Tobacco-Free Snuff for Smokeless Tobacco Reduction

A Pilot Study to Compare the Nicotine Lozenge and Tobacco-Free Snuff for Smokeless Tobacco Reduction

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Smokeless tobacco (ST) is a known human carcinogen. Long-term ST use is known to increase the risk for oropharyngeal cancer. Extant literature on cigarette smokers suggests that smoking reduction increases smoking abstinence among smokers not interested in quitting. The overarching goal of this line of research is to develop a ST reduction intervention among ST users not interested in quitting tobacco. Our first step is to conduct the proposed pilot study designed to assess the efficacy of the nicotine lozenges or tobacco-free snuff for reducing ST use or facilitating ST abstinence among ST users not interested in quitting.

Detailed description

In this study, we will enroll 81 subjects who will be randomized to either the nicotine lozenge or tobacco-free snuff to reduce their ST use over 8 weeks with follow-up at 12 weeks. Forty subjects will be recruited at Mayo Clinic in Rochester, MN, and 40 subjects will be recruited at the Oregon Research Institute in Eugene, Oregon.

Conditions

• Tobacco Dependence

Interventions

Type	Name	Description
DRUG	nicotine lozenges	4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day.
DRUG	tobacco-free snuff	Tobacco-free snuff used ad lib for a maximum of 12 weeks

Timeline

• Start date: 2009-01-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2009-11-23
• Last updated: 2013-09-13
• Results posted: 2013-09-13

Locations

2 sites across 1 country: United States