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Completed

NCT Number: NCT00770666

Combination Medications vs. Patch Alone for Medically-Ill Smokers

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

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Umdnj-Rwjms

New Brunswick, New Jersey, 08903, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nicotine patch, nicotine inhaler, bupropion

Drug

Patch - 21 mg - taper as able Inhaler - as needed Bupropion SR 150 mg daily

Nicotine patch

Drug

21 mg daily for 6 weeks followed by 14 mg for 2 weeks and then 7 mg for 2 weeks

Primary outcomes

  1. Tobacco use abstinence

    Time frame: 26 week

Secondary outcomes

  1. Time to first relapse

    Time frame: varies

  2. Duration of medication use

    Time frame: 26 weeks

  3. Adverse clinical events

    Time frame: 26 weeks

Sponsors and collaborators

Lead sponsor

University of Medicine and Dentistry of New Jersey

Other

Collaborators

  • Robert Wood Johnson Foundation
  • Rutgers Cancer Institute of New Jersey

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2008
First posted
Oct 10, 2008
Registry last updated
Oct 10, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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