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

Sponsor:	University of Medicine and Dentistry New Jersey
Collaborators:	Cancer Institute of New Jersey Robert Wood Johnson Foundation
Information provided by:	University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:	NCT00770666

Purpose

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

Condition	Intervention	Phase
Smoking Cessation	Drug: Nicotine patch, nicotine inhaler, bupropion Drug: Nicotine patch	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Flexibly-Dosed Combination Pharmacotherapy Versus Standard-Dosed Nicotine Patch Alone for Smokers With Medical Illness

Resource links provided by NLM:

MedlinePlus related topics: Quitting Smoking

Drug Information available for: Nicotine tartrate Bupropion hydrochloride Bupropion Nicotine polacrilex

U.S. FDA Resources

Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	127
Study Start Date:	September 2005
Study Completion Date:	January 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Nicotine patch, nicotine inhaler, bupropion	Drug: Nicotine patch, nicotine inhaler, bupropion Patch - 21 mg - taper as able Inhaler - as needed Bupropion SR 150 mg daily
2: Active Comparator Nicotine patch	Drug: Nicotine patch 21 mg daily for 6 weeks followed by 14 mg for 2 weeks and then 7 mg for 2 weeks

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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00770666

Locations

United States, New Jersey
UMDNJ-RWJMS
New Brunswick, New Jersey, United States, 08903

Sponsors and Collaborators

University of Medicine and Dentistry New Jersey

Cancer Institute of New Jersey

Robert Wood Johnson Foundation

Investigators

Principal Investigator:

Michael B Steinberg, MD, MPH

UMDNJ-RWJMS

More Information

No publications provided by University of Medicine and Dentistry New Jersey

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	UMDNJ-Robert Wood Johnson Medical School ( Michael Steinberg, MD, MPH )
Study ID Numbers:	0220055373
Study First Received:	October 9, 2008
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00770666 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Medicine and Dentistry New Jersey:

Tobacco dependence treatment

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Nicotine polacrilex
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Nicotinic Agonists
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Stimulants
Cholinergic Agents

Pharmacologic Actions
Nicotine
Autonomic Agents
Therapeutic Uses
Bupropion
Ganglionic Stimulants
Dopamine Agents
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on February 04, 2010