Smoking Cessation Intervention: Effectiveness in Primary Care

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.

Inclusion Criteria:

- Smoke at least 10 cigarettes per day for the previous 6 months - Expired CO > 9 ppm -
Motivated to quit smoking - Able to read and write English - Willing to complete
required study assessments, Aurora participating clinic patient

Exclusion Criteria:

- Uncontrolled hypertension (systolic >180mm Hg or diastolic >110mm Hg) - History of
bipolar disorder or psychosis - Myocardial infarction or other serious cardiac
problem in the previous 4 weeks - History of diagnosed anorexia and/or bulimia -
Diagnosis of Alcohol Dependence in the previous 6 months by participant self-report
or drinking 6 or more drinks on six or more days a week - History of seizure and/or
serious head injury involving loss of consciousness - Use of contraindicated
medications (MAO inhibitors, bupropion, lithium, anticonvulsants, antipsychotics) -
Currently pregnant or breast-feeding - Unwilling to use effective contraception
during the treatment phase - More than one participant from the same household -
Allergic reactions to 3 or more classes of drugs