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

National Institutes of Health Clinical Center (CC)

Status: Completed

Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Cancer Survivor

Treatments: Behavioral: smoking cessation intervention; Drug: bupropion hydrochloride

Study type: Interventional

Funder types: NIH

Identifiers

NCT00079469

03-C-N308

CDR0000356037

999903308

Details and patient eligibility

About

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.

Full 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 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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