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

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00079469
• Other study ID #: 999903308
• Secondary ID: 03-C-N308CDR0000
• Status: Completed
• Phase: N/A
• First received: March 8, 2004
• Last updated: March 7, 2012
• Start date: February 2004
• Est. completion date: August 2004

Study information

• Verified date: March 2012
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cancer Survivor
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Behavioral:
• smoking cessation intervention

Drug:
• bupropion hydrochloride

Locations

Country	Name	City	State
United States	Tobacco Control Research Branch	Rockville	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
National Institutes of Health Clinical Center (CC)	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,