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

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00079469

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	Intervention
Cancer Survivor Unspecified Adult Solid Tumor, Protocol Specific	Behavioral: smoking cessation intervention Drug: bupropion hydrochloride

Study Type:	Interventional
Study Design:	Prevention, Randomized, Active Control
Official Title:	Contingency Management to Enhance Smoking Cessation for Cancer Survivors: A Proof of Concept Trial

Resource links provided by NLM:

MedlinePlus related topics: Cancer Quitting Smoking Smoking

Drug Information available for: Bupropion hydrochloride Bupropion

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

February 2004

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00079469

Locations

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

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

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

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000356037, NCI-03-C-N308
Study First Received:	March 8, 2004
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00079469 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

cancer survivor
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Pharmacologic Actions

Therapeutic Uses
Bupropion
Dopamine Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 09, 2009