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

• Status: Completed
• Trial end date: 2004-08-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institutes of Health Clinical Center (CC)
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bupropion

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