Status:
COMPLETED
Combination Medications vs. Patch Alone for Medically-Ill Smokers
Lead Sponsor:
University of Medicine and Dentistry of New Jersey
Collaborating Sponsors:
Rutgers Cancer Institute of New Jersey
Robert Wood Johnson Foundation
Conditions:
Smoking Cessation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Randomized clinical trial to evaluate a flexibly-dosed-3-medication combination for up to 6 months in smokers with medical illness
Detailed Description
Subjects randomly received either nicotine patch alone for a 10-week, tapering course (n=64) or the combination of nicotine patch, nicotine oral inhaler, and bupropion for an ad-lib duration (n=63).
Eligibility Criteria
Inclusion
- currently smoking at least 10 cigarettes per day (confirmed by high exhaled carbon-monoxide (CO))
- 18 years or older
- interested in quitting within the next 30 days
- one or more pre-defined medical illnesses (including cardiovascular disease, other vascular disease, chronic pulmonary disease, cancer, hypertension, diabetes, hyperlipidemia, and recurrent pulmonary infections)
Exclusion
- contraindications to pharmacotherapy (including unstable angina, myocardial infarction within 2 months, severe arrhythmia, seizure disorder, serious mental illness requiring antipsychotic medications)
- current use of other tobacco products (smokeless tobacco, cigars, pipes, etc.), bupropion, clonidine, nortriptyline, or nicotine replacement medications
- unable to give consent
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT00770666
Start Date
September 1 2005
End Date
January 1 2008
Last Update
October 10 2008
Active Locations (1)
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1
Umdnj-Rwjms
New Brunswick, New Jersey, United States, 08903