Contingency Management to Enhance Smoking Cessation for Cancer Survivors: A Proof of Concept Trial
18 Years
N/A
Both
Cancer Survivor, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Contingency Management to Enhance Smoking Cessation for Cancer Survivors: A Proof of Concept Trial
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Prevention
Principal Investigator
Glen D. Morgan, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
NCI - Division of Cancer Control and Population Science
Authority:
United States: Federal Government
Study ID:
999903308
NCT ID:
NCT00079469
Start Date:
February 2004
Completion Date:
August 2004
Related Keywords:
- Cancer Survivor
- Unspecified Adult Solid Tumor, Protocol Specific
- cancer survivor
- unspecified adult solid tumor, protocol specific
Name | Location |
|---|---|
| Tobacco Control Research Branch | Rockville, Maryland 20852 |
