Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Prevention	Closed	18 and over	NCI	NCI-03-C-N308 NCT00079469

Objectives

Primary

1. 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.
2. Compare 7-day point-prevalence abstinence rates in patients treated with these smoking cessation interventions.

Secondary

1. Determine the characteristics of these patients that predict success at quitting smoking.

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Platelet count ≥ 100,000 - 450,000/mm³
• WBC ≥ 3,000/mm³

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

Expected Enrollment

A total of 100 patients (50 per intervention arm) will be accrued for this study within 8 months.

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.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Glen Morgan, PhD, Principal investigator		Ph: 301-451-5048 Email: gmorgan@nih.gov
Sandra Schaefer, RN, BSN, OCN, Study coordinator		Ph: 301-451-5048 Email: schaefes@mail.nih.gov

Registry Information
Official Title		Contingency Management to Enhance Smoking Cessation for Cancer Survivors: A Proof of Concept Trial
Trial Start Date		2004-02-10
Registered in ClinicalTrials.gov		NCT00079469
Date Submitted to PDQ		2004-02-10
Information Last Verified		2004-07-16

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