NCT00392379

Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction

Evaluating Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Smokeless tobacco (ST) users will be randomly assigned to either the 4-mg active nicotine lozenge or matching placebo. Both groups will receive a behavioral intervention. The two sites for this clinical trial will be the Mayo Clinic in Rochester, Minnesota (central coordinating site) and the Oregon Research Institute (ORI) in Eugene, OR. A total of 270 ST users will be recruited into this clinical trail. All subjects will be randomized to 4 mg Nicotine Lozenges (taken ad lib) or matching placebo. They will be on study medication for 12 weeks and followed up for 6 months from study enrollment

Conditions

• Smokeless Tobacco Use

Interventions

Type	Name	Description
DRUG	Nicotine Lozenges	Nicotine lozenges, 4 mg
DRUG	Placebo lozenge	Placebo lozenge

Timeline

• Start date: 2007-01-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2006-10-26
• Last updated: 2013-04-24
• Results posted: 2010-08-30

Locations

2 sites across 1 country: United States