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Bupropion and Counseling With or Without Contingency Management to Enhance Smoking Cessation in Treating Cancer Survivors Who Continue to Smoke - Article


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Bupropion Sustained-Release (Zyban)

Buproban; Zyban 




Clinical Trial: Bupropion and Counseling With or Without Contingency Management to Enhance Smoking Cessation in Treating Cancer Survivors Who Continue to Smoke

This study is no longer recruiting patients.

Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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 Treatment or Intervention
unspecified adult solid tumor, protocol specific
 Drug: bupropion
 Procedure: cancer prevention intervention
 Procedure: educational intervention
 Procedure: smoking cessation intervention

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy

Study Type: Interventional
Study Design: Prevention

Official Title: Randomized Study of Bupropion and Counseling With or Without Contingency Management to Enhance Smoking Cessation in Cancer Survivors Who Continue to Smoke

Further Study Details: 

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 above,  Genders Eligible for Study:  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

Location Information


Maryland
      Tobacco Control Research Branch, Rockville,  Maryland,  20852,  United States

Study chairs or principal investigators

Glen D. Morgan, PhD,  Principal Investigator,  Division of Cancer Control and Population Science   
Sandra J. Schaefer, RN, BSN, OCN,  Tobacco Control Research Branch   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000356037; NCI-03-C-N308
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  March 8, 2004
ClinicalTrials.gov Identifier:  NCT00079469
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005

Resources



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November 27, 2009



Page Updated: June 1, 2005
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