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Combination Medications vs. Patch Alone for Medically-Ill Smokers
This study has been completed.
Study NCT00770666   Information provided by University of Medicine and Dentistry New Jersey
First Received: October 9, 2008   No Changes Posted

October 9, 2008
October 9, 2008
September 2005
December 2007   (final data collection date for primary outcome measure)
Tobacco use abstinence [ Time Frame: 26 week ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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 ]
Same as current
 
Combination Medications vs. Patch Alone for Medically-Ill Smokers
Flexibly-Dosed Combination Pharmacotherapy Versus Standard-Dosed Nicotine Patch Alone for Smokers With Medical Illness

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

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).

Phase IV
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Smoking Cessation
  • Drug: Nicotine patch, nicotine inhaler, bupropion
  • Drug: Nicotine patch
  • Experimental: Nicotine patch, nicotine inhaler, bupropion
  • Active Comparator: Nicotine patch
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.
 
Completed
127
January 2008
December 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00770666
Michael Steinberg, MD, MPH, UMDNJ-Robert Wood Johnson Medical School
0220055373
University of Medicine and Dentistry New Jersey
  • Cancer Institute of New Jersey
  • Robert Wood Johnson Foundation
Principal Investigator: Michael B Steinberg, MD, MPH UMDNJ-RWJMS
University of Medicine and Dentistry New Jersey
October 2008

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