Bupropion With Telephone-Based Counseling and/or Internet-Based Counseling in Helping Adults Stop Smoking
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Unspecified Adult Solid Tumor, Protocol Specific
Intervention: bupropion hydrochloride (Drug); counseling (Procedure); smoking cessation intervention (Procedure)
Phase: N/A
Status: Active, not recruiting
Sponsored by: SRI International Official(s) and/or principal investigator(s):
Gary E. Swan, PhD, Study Chair, Affiliation: SRI International
Summary
RATIONALE: Bupropion may help people quit smoking by decreasing the symptoms of nicotine
withdrawal. It is not yet known whether bupropion is more effective in helping people stop
smoking when given together with a telephone-based counseling program, and Internet-based
counseling program, or both programs.
PURPOSE: This randomized clinical trial is studying how well giving bupropion together with a
telephone-based counseling program and/or an Internet-based counseling program works in
helping adults stop smoking.
Clinical Details
Official title: Treatment of Nicotine Dependence in a Health Care Setting
Study design: Prevention, Randomized, Open Label
Detailed description:
OBJECTIVES:
Determine the effectiveness of bupropion hydrochloride with telephone counseling vs
Internet-based counseling vs telephone counseling and Internet-based smoking cessation
interventions in adult smokers.
Determine individual or group differences in patients undergoing these
interventions.
Determine heterogeneity in responsiveness in regard to the Classification and Regression Tree
Analysis in patients undergoing these interventions.
Determine the effectiveness of these interventions in regard to recruitment, implementation,
barriers to treatment, exposure to intervention, satisfaction with treatment, treatment
contamination, and program maintenance.
Determine the cost-effectiveness of these interventions.
OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 3
intervention arms.
Arm I: Patients undergo a proactive telephone-based (PTB) smoking cessation program.
Arm II: Patients undergo a web-based (WB) smoking cessation program.
Arm III: Patients undergo an integrated PTB/WB smoking cessation program. Beginning 1 week
before the target quit date, all patients receive oral bupropion hydrochloride daily for 8
weeks. They also receive a mailed packet containing a welcome letter, description of the
intervention services offered, a privacy notice, a Free & Clear Quit Kit (comprehensive
education/self-help materials including health smoking substitutions), a phone call to orient
the patient to the intervention to which they are randomized, and access to a toll-free
support line. All patients undergo a pre-treatment assessment (pre-quit) and 4 post-quit
assessments at 7 days, 7 weeks, 6 months, and 12 months after their original scheduled quit
date to determine medication adherence, treatment utilization, point-prevalent smoking
outcomes, and continuous nonsmoking.
PROJECTED ACCRUAL: A total of 1,200 patients will be accrued for this study.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS:
Smokes 10 or more cigarettes/day over the past year AND ≥ 5 cigarettes/day within the past
week
Planning to stop smoking in 4-6 weeks
Member of Group Health Cooperative (GHC) and planning to stay enrolled for the next 6
months
Eligible for the Free & Clear program
Enrolled in the COMPASS study using bupropion hydrochloride medication
No prior participation in GHC's Free & Clear smoking cessation program within the past 6
months
PATIENT CHARACTERISTICS:
In good general health
Sufficient verbal and written English
Dependable access to a telephone and the Internet
Not currently drinking ≥ 14 alcoholic drinks per week and/or binge drinking ≥ 2 times in
the past month
Not pregnant or nursing
No plan to become pregnant
No severe chronic heart disease (e. g, myocardial infarction within the past 3 months)
No severe chronic obstructive pulmonary disease that ever required hospitalization or
oxygen treatment
No diagnosis of or treatment for a psychotic disorder (e. g., schizophrenia, bipolar
disorder, or mania)
Not having certain kidney problems
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
No concurrent use of medications contraindicated with bupropion hydrochloride or known to
lower seizure threshold (e. g., antidepressant, antipsychotic, monamine oxidase inhibitor,
or protease inhibitor)
No concurrent use of recreational or street drugs
No concurrent use of bupropion hydrochloride or nicotine replacement therapy
No concurrent cimetidine, metformin, phenformin, pindolol, procainamide
Not on dialysis
Locations and Contacts
SRI International, Menlo Park, California 94025, United States
Center for Health Studies, Seattle, Washington 98101-1448, United States
Free & Clear, Incorporated, Seattle, Washington 98104, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: October 2005
Last updated: December 25, 2007
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