Smoking Cessation Treatment for Methadone Maintenance Patients
Patients in substance abuse treatment smoke four times more than non-substance abusers, and suffer high rates of tobacco-related disease and death. While many quit smoking treatments exist that have been shown to help non-substance abusers quit smoking, little is known about what treatments work for patients in substance abuse treatment. The drug varenicline (Chantix) has been shown to be more...
Brief Summary
Official Title: “Smoking Cessation Treatment for Methadone Maintenance Patients”
Patients in substance abuse treatment smoke four times more than non-substance abusers, and suffer high rates of tobacco-related disease and death. While many quit smoking treatments exist that have been shown to help non-substance abusers quit smoking, little is known about what treatments work for patients in substance abuse treatment. The drug varenicline (Chantix) has been shown to be more effective at helping people quit smoking than nicotine replacement therapy, bupropion or placebo. However, varenicline has not yet been studied in patients in substance abuse treatment. The study aims to evaluate the feasibility, effectiveness and safety of varenicline, in combination with counseling, in methadone maintained smokers. It also aims to evaluate the link between quitting smoking and alcohol and illicit drug use in methadone maintained smokers. We hypothesize that participants receiving varenicline will have higher abstinence from smoking than participants receiving placebo and that participants taking varenicline will not have significantly more adverse reactions than were described in the general population in other studies. We also hypothesize that compared to continued smokers, tobacco abstainers will be more likely to be abstinent from alcohol or illicit drugs.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
- Study Primary Completion Date: August 2014
Intervention(s) in this Clinical Trial
- Drug: Varenicline
- Days 1-3: 0.5 mg once a day Days 4-7: 0.5 mg twice a day Days 8-84: 1 mg twice a day
- Drug: Placebo
- Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: Varenicline
- Drug treatment in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
- Placebo Comparator: Placebo
- Matched placebo capsules in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12
Outcome Measures for this Clinical Trial
Primary Measures
- 7-day point prevalence abstinence at 12 weeks (verified by salivary cotinine).
- Time Frame: 12 weeks
Safety Issue?: No
- Time Frame: 12 weeks
Secondary Measures
- Adverse medication effects, psychiatric symptoms, and psychiatric disease.
- Time Frame: Weeks 2, 4, 8, 12, and 24
Safety Issue?: Yes
- Time Frame: Weeks 2, 4, 8, 12, and 24
- Intervention Feasibility (evaluation of study participation, counseling contacts, adherence to medication therapy, and participant satisfaction.)
- Time Frame: Study participation, counseling contacts, and participant satisfaction at Week 12; medication adherence at Weeks 2, 4, 8, and 12.
Safety Issue?: No
- Time Frame: Study participation, counseling contacts, and participant satisfaction at Week 12; medication adherence at Weeks 2, 4, 8, and 12.
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Age 18 or older
- English speaking
- Smoked at least 100 cigarettes/lifetime
- Smokes 5 or more cigarettes per day
- Interested in quitting smoking (preparation or contemplation state of change)
- Enrolled in Einstein/Montefiore methadone program for 3 or more months
- Stable methadone dose for 2 weeks
- Agree to use contraception throughout the trial (among women with reproductive potential)
- Willing to participate in all study components
- Able to provide informed consent
Exclusion Criteria:
- Serious or unstable HIV/AIDS, liver, cardiovascular, or pulmonary disease
- Psychiatric instability
- Women who are pregnant, breastfeeding, or contemplating pregnancy
- Creatinine clearance less than 30 mL/min
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Albert Einstein College of Medicine of Yeshiva University Other
Overall Clinical Trial Officials and Contacts
Shadi Nahvi, M.D., M.S. Principal Investigator Albert Einstein College of Medicine of Yeshiva University
Overall Contact: Shadi Nahvi, M.D., M.S. (718) 944-3844 snahvi@dosa.aecom.yu.edu
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01027754
Study ID Number: 2008-537
ClinicalTrials.gov Identifier: NCT01027754
Health Authority: United States: Federal Government
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01027754
