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

NCT ID: NCT00079469

Last Updated: 2012-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2004-08-31

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 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.

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 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.

Conditions

Cancer Survivor; Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: PREVENTION

Interventions

smoking cessation intervention

Intervention Type: BEHAVIORAL

bupropion hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

National Institutes of Health Clinical Center (CC)

NIH

Sponsor Role: lead

Principal Investigators

Glen D. Morgan, PhD

Role: PRINCIPAL_INVESTIGATOR

NCI - Division of Cancer Control and Population Science

Sandra J. Schaefer, RN, BSN, OCN

Role:

National Cancer Institute (NCI)

Locations

Tobacco Control Research Branch

Rockville, Maryland, United States

Countries

United States

Other Identifiers

03-C-N308

Identifier Type: -

Identifier Source: secondary_id

CDR0000356037

Identifier Type: -

Identifier Source: secondary_id

999903308

Identifier Type: -

Identifier Source: org_study_id