Combination Medications vs. Patch Alone for Medically-Ill Smokers

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00770666
• Other study ID #: 0220055373
• Status: Completed
• Phase: Phase 4
• First received: October 9, 2008
• Last updated: October 9, 2008
• Start date: September 2005
• Est. completion date: January 2008

Study information

• Verified date: October 2008
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: January 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• Nicotine patch, nicotine inhaler, bupropion
Patch - 21 mg - taper as able Inhaler - as needed Bupropion SR 150 mg daily
• Nicotine patch
21 mg daily for 6 weeks followed by 14 mg for 2 weeks and then 7 mg for 2 weeks

Locations

Country	Name	City	State
United States	Umdnj-Rwjms	New Brunswick	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey	Robert Wood Johnson Foundation, Rutgers Cancer Institute of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tobacco use abstinence		26 week	No
Secondary	Time to first relapse		varies	No
Secondary	Duration of medication use		26 weeks	No
Secondary	Adverse clinical events		26 weeks	Yes