Combination Medications vs. Patch Alone for Medically-Ill Smokers

Flexibly-Dosed Combination Pharmacotherapy Versus Standard-Dosed Nicotine Patch Alone for Smokers With Medical Illness

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00770666

Enrollment

127

Registered

2008-10-10

Start date

2005-09-30

Completion date

2008-01-31

Last updated

2008-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

Keywords

Tobacco dependence treatment

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).

Interventions

DRUGNicotine patch, nicotine inhaler, bupropion

Patch - 21 mg - taper as able Inhaler - as needed Bupropion SR 150 mg daily

DRUGNicotine patch

21 mg daily for 6 weeks followed by 14 mg for 2 weeks and then 7 mg for 2 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Tobacco use abstinence	26 week

Secondary

Measure	Time frame
Time to first relapse	varies
Duration of medication use	26 weeks
Adverse clinical events	26 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026