Contingency Management to Enhance Smoking Cessation for Cancer Survivors: A Proof of Concept Trial
Data Collection
Prevention Study
Summary
Study start date: February 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location