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

National Institutes of Health Clinical Center (CC)

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Conditions

Cancer Survivor Unspecified Adult Solid Tumor, Protocol Specific

Interventions

smoking cessation interventionBEHAVIORAL

bupropion hydrochlorideDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Tobacco Control Research Branch

Rockville, Maryland, United States

Data from ClinicalTrials.gov

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