Conditions: Tobacco Dependence
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1346
Healthy volunteers: no

Brief summary:
The information gathered in this study may help to develop more effective ways to help people quit smoking and stay quit in the future.

Detailed description:
Randomized clinical trials may not accurately reflect the public health benefit of tobacco dependence pharmacotherapies when used in real-world clinical settings due to differences in patient selection, motivation, and adherence. To have a positive public health impact, a treatment must be accessible and acceptable to a broad range of smokers and effective under normal use conditions. The proposed project will assess primary care patients willingness to use cessation treatment and will determine the relative effectiveness of five cessation pharmacotherapies. This research builds on a primary care clinic-based recruitment strategy that was highly successful in a previous study. In the proposed research, 1320 primary care patients presenting for a regular outpatient visit will be recruited by medical assistants to participate in a free smoking cessation program and will be randomly assigned to one of five active pharmacotherapies: patch, lozenge, bupropion, patch+lozenge, and bupropion+lozenge (n = 264/condition). Interested participants who pass medical screening will pick up their medications at clinic pharmacies and will receive proactive telephone counseling from the Wisconsin Tobacco Quit Line. Assessment will be limited to preserve the generalizability of the findings, but select individual differences will be assessed pre-quit to validate algorithms (from Project 1: Efficacy) designed to optimize pharmacotherapy selection for smokers based on gender, level of dependence, and other factors. Smoking behavior will be assessed at six months and one year post-quit so that abstinence rates across pharmacotherapy conditions can be compared. The cost of incorporating tobacco dependence treatment into primary care will also be estimated.

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None

Interventions: intervention 1: nicotine patch intervention 2: nicotine patch intervention 3: nicotine lozenge intervention 4: bupropion intervention 5: patch + lozenge intervention 6: bupropion + lozenge
Intervention descriptions: intervention 1: Decreasing dosages from 21 to 7 mg over 12 week period intervention 2: Decreasing dosage from 21 to 7 mg over 12 weeks intervention 3: 4 mg nicotine lozenge: dosage according to package directions for 16 weeks intervention 4: dosage according to prescription directions: 12 weeks intervention 5: dosage of each according to package insert directions (12 weeks patch, 16 weeks lozenge) intervention 6: dosage of each according to prescription or package insert (12 weeks bupropion, 16 weeks lozenge)

Protocol document: