Smoking Cessation Intervention: Effectiveness in Primary Care

Study Overview
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Brief Summary
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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
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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.

Official Title
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Tobacco Dependence: Treatment and Outcomes; Pharmacotherapies: Effectiveness in Primary Care

Conditions
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Tobacco Dependence

Intervention / Treatment
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* Drug: nicotine patch
* Drug: nicotine patch
* Drug: nicotine lozenge
* Drug: bupropion
* Drug: patch + lozenge
* Drug: bupropion + lozenge


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: patch<br> | Drug: nicotine patch<br>* Decreasing dosages from 21 to 7 mg over 12 week period<br>Drug: nicotine patch<br>* Decreasing dosage from 21 to 7 mg over 12 weeks<br>|
| Active Comparator: nicotine lozenge<br> | Drug: nicotine lozenge<br>* 4 mg nicotine lozenge: dosage according to package directions for 16 weeks<br>|
| Active Comparator: bupropion<br> | Drug: bupropion<br>* dosage according to prescription directions: 12 weeks<br>|
| Active Comparator: patch + lozenge<br> | Drug: patch + lozenge<br>* dosage of each according to package insert directions (12 weeks patch, 16 weeks lozenge)<br>|
| Active Comparator: buproion + lozenge<br> | Drug: bupropion + lozenge<br>* dosage of each according to prescription or package insert (12 weeks bupropion, 16 weeks lozenge)<br>|

What is the study measuring?
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Primary Outcome Measures

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