Completed

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

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What is being tested

smoking cessation intervention

+ bupropion hydrochloride
Behavioral
Drug
Who is being recruted

Cancer Survivor

+ Unspecified Adult Solid Tumor, Protocol Specific
Over 18 Years
How is the trial designed

Prevention Study

Interventional
Study Start: February 2004

Summary

Principal SponsorNational Institutes of Health Clinical Center (CC)
Last updated: March 8, 2012
Sourced from a government-validated database.Claim as a partner
Study start date: February 1, 2004Actual date on which the first participant was enrolled.

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.

Official TitleContingency Management to Enhance Smoking Cessation for Cancer Survivors: A Proof of Concept Trial 
Principal SponsorNational Institutes of Health Clinical Center (CC)
Last updated: March 8, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Cancer Survivor
Unspecified Adult Solid Tumor, Protocol Specific
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
Suspended
Tobacco Control Research BranchRockville, United StatesSee the location

CompletedOne Study Center