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

NCT00079469 | Completed

• 3 other identifiers: 99990330803-C-N308CDR0000356037
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Survivor; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

cancer survivor; unspecified adult solid tumor, protocol specific

Interventions

smoking cessation intervention BEHAVIORAL

bupropion hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Tobacco Control Research Branch

Rockville, Maryland, 20852, United States

Location

MeSH Terms

Interventions

Bupropion

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals

Study Officials

• Glen D. Morgan, PhD

  NCI - Division of Cancer Control and Population Science

  PRINCIPAL INVESTIGATOR

• Sandra J. Schaefer, RN, BSN, OCN

  National Cancer Institute (NCI)

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: PREVENTION
• Sponsor Type: NIH

Study Record Dates

• First Submitted: March 8, 2004
• First Posted: March 10, 2004
• Study Start: February 1, 2004
• Study Completion: August 1, 2004
• Last Updated: March 8, 2012

Record last verified: 2012-03

Locations

US (1)