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Contingency Management to Enhance Smoking Cessation for Cancer Survivors: A Proof of Concept Trial


N/A
18 Years
N/A
Not Enrolling
Both
Cancer Survivor, Unspecified Adult Solid Tumor, Protocol Specific

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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 BranchRockville, Maryland  20852