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

Completed · Not applicable · Has a placebo group

Conditions studied: Bladder Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer, Head and Neck Cancer, Kidney Cancer, Leukemia, Liver Cancer, Lung Cancer, Pancreatic Cancer, Tobacco Use Disorder

In brief

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.

Key facts

Study ID

NCT00790569

Run by

Butler Hospital

People needed

315

Starts

2008-09-01

Expected to finish

2012-10-01

Last updated by the study team

2018-06-06

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Rhode Island Hospital Comprehensive Cancer Center — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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