Status:
COMPLETED
Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking
Lead Sponsor:
Butler Hospital
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Bladder Cancer
Cervical Cancer
Eligibility:
All Genders
18-120 years
Phase:
NA
Brief 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 gu...
Detailed Description
OBJECTIVES: Primary * To determine whether varenicline, a nicotine receptor partial agonist, leads to a higher rate of smoking cessation than combination nicotine replacement therapy with nicotine p...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
315 Patients enrolled
Trial Details
Trial ID
NCT00790569
Start Date
September 1 2008
End Date
October 1 2012
Last Update
June 6 2018
Active Locations (1)
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1
Rhode Island Hospital Comprehensive Cancer Center
Providence, Rhode Island, United States, 02903