Combination Medications vs. Patch Alone for Medically-Ill Smokers - Tabular View

Tracking Information

First Received Date ^ICMJE

October 9, 2008

Last Updated Date

October 9, 2008

Start Date ^ICMJE

September 2005

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Tobacco use abstinence [ Time Frame: 26 week ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Time to first relapse [ Time Frame: varies ] [ Designated as safety issue: No ]
Duration of medication use [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Adverse clinical events [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Combination Medications vs. Patch Alone for Medically-Ill Smokers

Official Title ^ICMJE

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

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).

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Smoking Cessation

Intervention ^ICMJE

Drug: Nicotine patch, nicotine inhaler, bupropion
Drug: Nicotine patch

Study Arms / Comparison Groups

Experimental: Nicotine patch, nicotine inhaler, bupropion
Active Comparator: Nicotine patch

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

127

Completion Date

January 2008

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00770666

Responsible Party

Michael Steinberg, MD, MPH, UMDNJ-Robert Wood Johnson Medical School

Study ID Numbers ^ICMJE

0220055373

Study Sponsor ^ICMJE

University of Medicine and Dentistry New Jersey

Collaborators ^ICMJE

Cancer Institute of New Jersey
Robert Wood Johnson Foundation

Investigators ^ICMJE

Principal Investigator:

Michael B Steinberg, MD, MPH

UMDNJ-RWJMS

Information Provided By

University of Medicine and Dentistry New Jersey

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP