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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Institutes of Health Clinical Center (CC)

Study Description
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Brief Summary:

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

Detailed Description:

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 Design
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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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
United States, Maryland
Tobacco Control Research Branch
Rockville, Maryland, United States, 20852
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI)
Investigators
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)
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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