Smoking Cessation Intervention: Effectiveness in Primary Care

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1346 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2010-12-31

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.

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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.

Conditions

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Tobacco Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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patch

Group Type ACTIVE_COMPARATOR

nicotine patch

Intervention Type DRUG

Decreasing dosages from 21 to 7 mg over 12 week period

nicotine patch

Intervention Type DRUG

Decreasing dosage from 21 to 7 mg over 12 weeks

nicotine lozenge

Group Type ACTIVE_COMPARATOR

nicotine lozenge

Intervention Type DRUG

4 mg nicotine lozenge: dosage according to package directions for 16 weeks

bupropion

Group Type ACTIVE_COMPARATOR

bupropion

Intervention Type DRUG

dosage according to prescription directions: 12 weeks

patch + lozenge

Group Type ACTIVE_COMPARATOR

patch + lozenge

Intervention Type DRUG

dosage of each according to package insert directions (12 weeks patch, 16 weeks lozenge)

buproion + lozenge

Group Type ACTIVE_COMPARATOR

bupropion + lozenge

Intervention Type DRUG

dosage of each according to prescription or package insert (12 weeks bupropion, 16 weeks lozenge)

Interventions

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nicotine patch

Decreasing dosages from 21 to 7 mg over 12 week period

Intervention Type DRUG

nicotine patch

Decreasing dosage from 21 to 7 mg over 12 weeks

Intervention Type DRUG

nicotine lozenge

4 mg nicotine lozenge: dosage according to package directions for 16 weeks

Intervention Type DRUG

bupropion

dosage according to prescription directions: 12 weeks

Intervention Type DRUG

patch + lozenge

dosage of each according to package insert directions (12 weeks patch, 16 weeks lozenge)

Intervention Type DRUG

bupropion + lozenge

dosage of each according to prescription or package insert (12 weeks bupropion, 16 weeks lozenge)

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No