Conditions: Smokeless Tobacco Use
Keywords: Tobacco use disorder Tobacco cessation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 270
Healthy volunteers: no

Brief 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

Arms:
arm 1: 4 mg nicotine lozenges for 3 months arm 2: Placebo nicotine lozenges for 3 months

Interventions: intervention 1: Nicotine Lozenges intervention 2: Placebo lozenge
Intervention descriptions: intervention 1: Nicotine lozenges, 4 mg intervention 2: Placebo lozenge

Protocol document: