Combination Medications vs. Patch Alone for Medically-Ill Smokers
Phase 4
Completed
- Conditions
- Smoking Cessation
- Interventions
- Registration Number
- NCT00770666
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 127
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Nicotine patch Nicotine patch 1 Nicotine patch, nicotine inhaler, bupropion Nicotine patch, nicotine inhaler, bupropion
- Primary Outcome Measures
Name Time Method Tobacco use abstinence 26 week
- Secondary Outcome Measures
Name Time Method Time to first relapse varies Adverse clinical events 26 weeks Duration of medication use 26 weeks
Trial Locations
- Locations (1)
Umdnj-Rwjms
🇺🇸New Brunswick, New Jersey, United States