Expired Study
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Rockville, Maryland 20852


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00079469


Primary Contact:

Principal Investigator
Glen D. Morgan, PhD
NCI - Division of Cancer Control and Population Science


Backup Contact:

N/A


Location Contact:

Rockville, Maryland 20852
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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