Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Butler Hospital
• Collaborator: National Cancer Institute (NCI)
• Treatments: Methadone; Nicotine; Varenicline

Criteria

INCLUSION CRITERIA

• 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

EXCLUSION CRITERIA

• Pregnant or nursing (Must have negative pregnancy test)

• Non-English speaking

• No personal telephone or does not live close to a relative or neighbor with a telephone

• Unwilling to make their methadone dose and methadone maintenance treatment program urine toxicologies available for review

• Unvailable for this study for the next 12 months

• Suffering from any unstable medical condition which would preclude the use of the nicotine patch (e.g., unstable angina or uncontrolled hypertension)

• Active skin condition (e.g., psoriasis)

• History of skin allergy

• History of a suicide attempt

• 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