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

March 7, 2012 updated by: National Institutes of Health Clinical Center (CC)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institutes of Health Clinical Center (CC)

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Glen D. Morgan, PhD, NCI - Division of Cancer Control and Population Science
  • Sandra J. Schaefer, RN, BSN, OCN, National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Study Completion (Actual)

August 1, 2004

Study Registration Dates

First Submitted

March 8, 2004

First Submitted That Met QC Criteria

March 9, 2004

First Posted (Estimate)

March 10, 2004

Study Record Updates

Last Update Posted (Estimate)

March 8, 2012

Last Update Submitted That Met QC Criteria

March 7, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 999903308
  • 03-C-N308
  • CDR0000356037

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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