Bupropion and Counseling With or Without Contingency Management to Enhance Smoking Cessation in Treating Cancer Survivors Who Continue to Smoke
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ClinicalTrials.gov Identifier: NCT00079469 |
Recruitment Status
:
Completed
First Posted
: March 10, 2004
Last Update Posted
: March 8, 2012
|
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Cancer Survivor Unspecified Adult Solid Tumor, Protocol Specific | Behavioral: smoking cessation intervention Drug: bupropion hydrochloride | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
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 |
Actual Study Completion Date : | August 2004 |

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 | |
OverallOfficial: | Sandra J. Schaefer, RN, BSN, OCN | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00079469 History of Changes |
Other Study ID Numbers: |
999903308 03-C-N308 CDR0000356037 |
First Posted: | March 10, 2004 Key Record Dates |
Last Update Posted: | March 8, 2012 |
Last Verified: | March 2012 |
Keywords provided by National Institutes of Health Clinical Center (CC):
cancer survivor unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
Bupropion Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents Physiological Effects of Drugs Cytochrome P-450 CYP2D6 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors |