Smoking Cessation Intervention: Effectiveness in Primary Care

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00296647
Study type	Interventional
Source	University of Wisconsin, Madison
Contact
Status	Completed
Phase	Phase 4
Start date	September 2004
Completion date	December 2010

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.