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Varenicline Versus Nicotine Replacement for Methadone-Maintained Smokers

This study is currently Recruiting

June 2011 By Butler Hospital

First Recieved on November 11, 2008

Last Updated on June 28, 2011

Sponsor: Butler Hospital
Collaborators: National Cancer Institute (NCI)
Information provided by: Butler Hospital
Identifier: NCT00790569

Purpose

RATIONALE: Varenicline, the nicotine patch, and nicotine gum help people stop smoking. It is not yet known whether varenicline is more effective than the nicotine patch given together with nicotine gum in helping smokers quit smoking. PURPOSE: This randomized clinical trial is studying varenicline to see how well it works compared with the nicotine patch given together with nicotine gum in helping smokers in a methadone treatment program stop smoking.

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Eligibility

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

DISEASE CHARACTERISTICS: - Current and regular cigarette smokers (over 10 cigarettes/day for the past 3 months) - Interested in quitting smoking - Willing to set a quit date 7 days after baseline assessment - Participating in 1 of 5 methadone maintenance treatment programs across Rhode Island at any of the following institutions: - Codac, Inc. (with two independent sites) - Addiction Recovery Institute - Center for Treatment and Recovery - Discovery House - Has received methadone for at least the past month PATIENT CHARACTERISTICS: - Not pregnant or nursing - Negative pregnancy test - English speaking - Has a telephone or lives close to a relative or neighbor with a telephone - Willing to make their methadone dose and methadone maintenance treatment program urine toxicologies available for review - Available for this study for the next 12 months - Not suffering from any unstable medical condition which would preclude the use of the nicotine patch (e.g., unstable angina or uncontrolled hypertension) - No active skin condition (e.g., psoriasis) - No history of skin allergy - No history of a suicide attempt - Not working as pilots, drivers, or operators of heavy machinery PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No concurrent insulin or blood thinners - No concurrent smokeless tobacco, nicotine replacement therapy, or other smoking cessation treatment

Investigators

  • Investigator: Michael Stein, MD - Study Chair - Butler Hospital

Locations

  • Rhode Island Hospital Comprehensive Cancer Center

    Providence, Rhode Island 02903 United States

Conditions related to this trial:

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