View Clinical Trial (Medical Research Study)
Smoking Cessation Treatment for Methadone Maintenance Patients
| City: |
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Bronx |
| State: |
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New York |
| Zip Code: |
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10467 |
| Conditions: |
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Smoking Cessation - Substance-Related Disorders |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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
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| NCT ID: |
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NCT01027754 |
| Primary Contact: |
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Principal Investigator
Shadi Nahvi, M.D., M.S.
Albert Einstein College of Medicine of Yeshiva University
Shadi Nahvi, M.D., M.S.
Phone: (718) 944-3844
Email: snahvi@dosa.aecom.yu.edu
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| Backup Contact: |
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Email: lsher@montefiore.org
Lauren Sher
Phone: (718) 944-3855
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| Location Contact: |
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Bronx, New York 10467
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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