Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction
- Conditions
- Smokeless Tobacco Use
- Interventions
- Drug: Placebo lozenge
- Registration Number
- NCT00392379
- Lead Sponsor
- Mayo Clinic
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 270
- are at least 18 years of age;
- report smokeless tobacco (ST) as their primary tobacco of use;
- have used ST daily for the past 6 months;
- are in general good health (determined by medical history and screening physical examination);
- have been provided with, understand, and have signed the informed consent.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Nicotine Lozenges 4 mg nicotine lozenges for 3 months B Placebo lozenge Placebo nicotine lozenges for 3 months
- Primary Outcome Measures
Name Time Method Prolonged Smokeless Tobacco Abstinence at 3 Months 3 months Participants had to have self-reported not having used any tobacco from two weeks past the target quit date to the 3-months post baseline.
- Secondary Outcome Measures
Name Time Method Self-reported Point Prevalence All Tobacco Abstinence at 3 Months 3 months Participants had to have self-reported not having used any tobacco for the 7 days prior to the 3 month visit.
Prolonged Smokeless Tobacco Abstinence at 6 Months 6 months Participants had to have self-reported not having used any tobacco from 2 weeks after the target quit date to 6 months after baseline (22 weeks).
Trial Locations
- Locations (2)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Oregon Research Institute
🇺🇸Eugene, Oregon, United States