Combination Medications vs. Patch Alone for Medically-Ill Smokers

University of Medicine and Dentistry of New Jersey

Status and phase

Completed

Phase 4

Conditions

Smoking Cessation

Treatments

Drug: Nicotine patch, nicotine inhaler, bupropion

Drug: Nicotine patch

Study type

Interventional

Funder types

Other

Identifiers

NCT00770666

0220055373

Details and patient eligibility

About

Randomized clinical trial to evaluate a flexibly-dosed-3-medication combination for up to 6 months in smokers with medical illness

Full 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).

Enrollment

127 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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