Smoking Cessation Treatment for Methadone Maintenance Patients
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Smoking Cessation Substance-Related Disorders |
Drug: Varenicline Drug: Placebo |
Phase 4 |
| 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 |
| Official Title: | Smoking Cessation Treatment for Methadone Maintenance Patients |
- 7-day point prevalence abstinence at 12 weeks (verified by salivary cotinine). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Adverse medication effects, psychiatric symptoms, and psychiatric disease. [ Time Frame: Weeks 2, 4, 8, 12, and 24 ] [ Designated as safety issue: Yes ]
- 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. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 134 |
| Study Start Date: | August 2009 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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
Other Name: Chantix
|
|
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
|
Drug: Placebo
Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily
Other Name: Matched capsules
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Shadi Nahvi, M.D., M.S. | (718) 944-3844 | snahvi@dosa.aecom.yu.edu |
| Contact: Lauren Sher | (718) 944-3855 | lsher@montefiore.org |
| United States, New York | |
| Albert Einstein College of Medicine of Yeshiva University | Recruiting |
| Bronx, New York, United States, 10467 | |
| Principal Investigator: Shadi Nahvi, M.D., M.S. | |
| Principal Investigator: | Shadi Nahvi, M.D., M.S. | Albert Einstein College of Medicine of Yeshiva University |
More Information
No publications provided
| Responsible Party: | Dr. Shadi Nahvi, Albert Einstein College of Medicine of Yeshiva University |
| ClinicalTrials.gov Identifier: | NCT01027754 History of Changes |
| Other Study ID Numbers: | 2008-537 |
| Study First Received: | December 7, 2009 |
| Last Updated: | December 7, 2009 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
|
methadone maintenance |
Additional relevant MeSH terms:
|
Smoking Substance-Related Disorders Habits Mental Disorders Methadone Varenicline Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Antitussive Agents Respiratory System Agents Narcotics Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013