Bupropion and Counseling With or Without Contingency Management to Enhance Smoking Cessation in Treating Cancer Survivors Who Continue to Smoke
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cancer Survivor Unspecified Adult Solid Tumor, Protocol Specific |
Behavioral: smoking cessation intervention Drug: bupropion hydrochloride |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Prevention |
| Official Title: | Contingency Management to Enhance Smoking Cessation for Cancer Survivors: A Proof of Concept Trial |
| Study Start Date: | February 2004 |
| Study Completion Date: | August 2004 |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00079469
| United States, Maryland | |
| Tobacco Control Research Branch | |
| Rockville, Maryland, United States, 20852 | |
| Principal Investigator: | Glen D. Morgan, PhD | NCI - Division of Cancer Control and Population Science | |
| Investigator: | Sandra J. Schaefer, RN, BSN, OCN | National Cancer Institute (NCI) |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00079469 History of Changes |
| Other Study ID Numbers: | 999903308, 03-C-N308, CDR0000356037 |
| Study First Received: | March 8, 2004 |
| Last Updated: | March 7, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
cancer survivor unspecified adult solid tumor, protocol specific |
ClinicalTrials.gov processed this record on February 27, 2015