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Combination Medications vs. Patch Alone for Medically-Ill Smokers

NCT ID: NCT00770666

Last Updated: 2008-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2008-01-31

Brief Summary

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

Detailed Description

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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).

Conditions

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Smoking Cessation

Keywords

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Tobacco dependence treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Nicotine patch, nicotine inhaler, bupropion

Group Type EXPERIMENTAL

Nicotine patch, nicotine inhaler, bupropion

Intervention Type DRUG

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

2

Nicotine patch

Group Type ACTIVE_COMPARATOR

Nicotine patch

Intervention Type DRUG

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

Interventions

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Nicotine patch, nicotine inhaler, bupropion

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

Intervention Type DRUG

Nicotine patch

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rutgers Cancer Institute of New Jersey

OTHER

Sponsor Role collaborator

Robert Wood Johnson Foundation

OTHER

Sponsor Role collaborator

University of Medicine and Dentistry of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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UMDNJ-Robert Wood Johnson Medical School

Principal Investigators

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Michael B Steinberg, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

UMDNJ-RWJMS

Locations

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Umdnj-Rwjms

New Brunswick, New Jersey, United States

Site Status

Countries

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United States

References

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Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.

Reference Type DERIVED
PMID: 37230961 (View on PubMed)

Steinberg MB, Greenhaus S, Schmelzer AC, Bover MT, Foulds J, Hoover DR, Carson JL. Triple-combination pharmacotherapy for medically ill smokers: a randomized trial. Ann Intern Med. 2009 Apr 7;150(7):447-54. doi: 10.7326/0003-4819-150-7-200904070-00004.

Reference Type DERIVED
PMID: 19349630 (View on PubMed)

Other Identifiers

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0220055373

Identifier Type: -

Identifier Source: org_study_id