Combination Medications vs. Patch Alone for Medically-Ill Smokers
Flexibly-Dosed Combination Pharmacotherapy Versus Standard-Dosed Nicotine Patch Alone for Smokers With Medical Illness
1 other identifier
interventional
127
1 country
1
Brief Summary
Randomized clinical trial to evaluate a flexibly-dosed-3-medication combination for up to 6 months in smokers with medical illness
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2005
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 9, 2008
CompletedFirst Posted
Study publicly available on registry
October 10, 2008
CompletedOctober 10, 2008
October 1, 2008
2.2 years
October 9, 2008
October 9, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tobacco use abstinence
26 week
Secondary Outcomes (3)
Time to first relapse
varies
Duration of medication use
26 weeks
Adverse clinical events
26 weeks
Study Arms (2)
1
EXPERIMENTALNicotine patch, nicotine inhaler, bupropion
2
ACTIVE COMPARATORNicotine patch
Interventions
Patch - 21 mg - taper as able Inhaler - as needed Bupropion SR 150 mg daily
Eligibility Criteria
You may qualify if:
- currently smoking at least 10 cigarettes per day (confirmed by high exhaled carbon-monoxide (CO))
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Umdnj-Rwjms
New Brunswick, New Jersey, 08903, United States
Related Publications (2)
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.
PMID: 37230961DERIVEDSteinberg 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.
PMID: 19349630DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael B Steinberg, MD, MPH
UMDNJ-RWJMS
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 9, 2008
First Posted
October 10, 2008
Study Start
September 1, 2005
Primary Completion
December 1, 2007
Study Completion
January 1, 2008
Last Updated
October 10, 2008
Record last verified: 2008-10