Status:
COMPLETED
Bupropion and Counseling With or Without Contingency Management to Enhance Smoking Cessation in Treating Cancer Survivors Who Continue to Smoke
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Cancer Survivor
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
End Date :
August 1 2004
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00079469
Start Date
February 1 2004
End Date
August 1 2004
Last Update
March 8 2012
Active Locations (1)
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1
Tobacco Control Research Branch
Rockville, Maryland, United States, 20852