Bupropion and Counseling With or Without Contingency Management to Enhance Smoking Cessation in Treating Cancer Survivors Who Continue to Smoke

Study Overview
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Brief Summary
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RATIONALE: Contingency management is a behavioral treatment approach that provides immediate rewards for positive change in behavior such as quitting smoking. In this protocol, contingency management will be in the form of a cash reward. A smoking cessation (stop-smoking) program that combines contingency management with bupropion and counseling may be effective in helping cancer survivors stop smoking. PURPOSE: Randomized clinical trial to compare the effectiveness of bupropion and counseling with or without contingency management in helping cancer survivors stop smoking.

Detailed Description
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OBJECTIVES: Primary Compare the feasibility of a multi-component smoking cessation intervention comprising bupropion and counseling with or without contingency management (cash reward) for cancer survivors who continue to smoke. Compare 7-day point-prevalence abstinence rates in patients treated with these smoking cessation interventions. Secondary Determine the characteristics of these patients that predict success at quitting smoking. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 smoking cessation intervention arms. Arm I: Patients receive oral bupropion twice daily on weeks 1-12 and brief practical counseling (i.e., problem-solving strategies, stimulus control, stress management, and social support) on weeks 1-6. Arm II: Patients receive treatment as in arm I and contingency management (i.e., monetary reinforcement for not smoking) on weeks 1-6. In both arms, treatment continues in the absence of unacceptable toxicity. Patients are followed at 12 and 24 weeks after the completion of the smoking cessation interventions. PROJECTED ACCRUAL: A total of 100 patients (50 per intervention arm) will be accrued for this study within 8 months.

Official Title
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Contingency Management to Enhance Smoking Cessation for Cancer Survivors: A Proof of Concept Trial

Conditions
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Cancer Survivor, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Behavioral: smoking cessation intervention
* Drug: bupropion hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of cancer at least 6 months before study entry No carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, or CNS tumor Smoking history of at least 2 years Smoked cigarettes daily for the past 30 days Completed prior cancer treatment at least 6 months, but no more than 5 years before study entry Concurrent tamoxifen allowed PATIENT CHARACTERISTICS: Age 18 and over Performance status Not specified Life expectancy Not specified Hematopoietic Platelet count ≥ 100,000 - 450,000/mm^3 WBC ≥ 3,000/mm^3 Hepatic AST and ALT ≤ 2 times upper limit of normal Bilirubin ≤ 2.0 mg/dL Renal Creatinine < 2.0 mg/dL Cardiovascular No unstable cardiovascular disease, including any of the following: High-grade atrioventricular block Neurocardiogenic syncope Unstable angina Uncompensated congestive heart failure Poorly controlled hypertension Other Not pregnant or nursing Negative pregnancy test Able to undergo peripheral blood draw No port-a-cath or Hickman catheters Planning to reside in the Washington D.C. metro area for at least 1 year after study entry Willing to undergo urine testing for cotinine levels and breath testing for carbon monoxide monitoring No significant physical or psychological disability that would preclude study participation No known allergy to bupropion Baseline urine drug screen negative Prescribed pain medication allowed None of the following predisposing factors that may increase the risk of seizures with bupropion use: History of seizures Alcohol use > 4 oz/day History of closed head injury History of an eating disorder CNS infection No poorly controlled diabetes PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy See Disease Characteristics Radiotherapy Not specified Surgery Not specified Other At least 2 years since prior alcohol abuse or substance abuse therapy (except for tobacco use or dependence) More than 14 days since prior monoamine oxidase (MAO) inhibitor No concurrent MAO inhibitor No concurrent bupropion (Wellbutrin® or Wellbutrin SR®) No concurrent alcohol or substance abuse disorder treatment No concurrent nicotine replacement therapy No concurrent medications that lower seizure threshold (e.g., theophylline or short-acting benzodiazepines) No use of tobacco products (more than 1 time per week) other than cigarettes

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: Prevention
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: smoking cessation intervention|nan|
|Drug: bupropion hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer survivor, unspecified adult solid tumor, protocol specific