Smoking Cessation Intervention: Effectiveness in Primary Care

Phase 4

Completed

Conditions: Tobacco Dependence

Interventions: Drug: nicotine patch
Drug: nicotine lozenge
Drug: bupropion
Drug: patch + lozenge
Drug: bupropion + lozenge

Registration Number: NCT00296647

Lead Sponsor: University of Wisconsin, Madison

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1346

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patch	nicotine patch	-
nicotine lozenge	nicotine lozenge	-
bupropion	bupropion	-
patch + lozenge	patch + lozenge	-
buproion + lozenge	bupropion + lozenge	-

Primary Outcome Measures

Name	Time	Method
6 Month Self-reported Abstinence From Smoking	6 months	Primary postquit outcomes was 7-day point prevalence abstinence (0, abstinent; 1, smoking) at 6 months (based on the week 24 interview)

Secondary Outcome Measures