Bupropion and Counseling With or Without Contingency Management to Enhance Smoking Cessation in Treating Cancer Survivors Who Continue to Smoke
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on August 07, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Unspecified Adult Solid Tumor, Protocol Specific
Intervention: bupropion hydrochloride (Drug); cancer prevention intervention (Procedure); educational intervention (Procedure); smoking cessation intervention (Procedure)
Phase: N/A
Status: No longer recruiting
Sponsored by: National Cancer Institute (NCI) Official(s) and/or principal investigator(s):
Glen D. Morgan, PhD, Principal Investigator, Affiliation: Division of Cancer Control and Population Science
Sandra J. Schaefer, RN, BSN, OCN, Affiliation: National Cancer Institute (NCI)
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.
Clinical Details
Official title:
Contingency Management to Enhance Smoking Cessation for Cancer Survivors: A Proof of Concept Trial
Study design: Interventional, Prevention, Randomized, Active Control
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.
Eligibility
Minimum age: 18 Years.
Gender(s): Both.
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
Locations and Contacts
Tobacco Control Research Branch, Rockville, Maryland 20852, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Last updated: February 20, 2007
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