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


Phase 4
18 Years
N/A
Not Enrolling
Both
Smoking Cessation

Thank you

Trial Information

Flexibly-Dosed Combination Pharmacotherapy Versus Standard-Dosed Nicotine Patch Alone for 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).


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Tobacco use abstinence

Outcome Time Frame:

26 week

Safety Issue:

No

Principal Investigator

Michael B Steinberg, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

UMDNJ-RWJMS

Authority:

United States: Institutional Review Board

Study ID:

0220055373

NCT ID:

NCT00770666

Start Date:

September 2005

Completion Date:

January 2008

Related Keywords:

  • Smoking Cessation
  • Tobacco dependence treatment
  • Smoking

Name

Location

Umdnj-RwjmsNew Brunswick, New Jersey  08903