Clinical trial NCT01027754: Smoking Cessation Treatment for Methadone Maintenance Patients
Official title: Smoking Cessation Treatment for Methadone Maintenance Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking Cessation
Substance-Related Disorders
Keywords: methadone maintenance
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
First posted: 2009-12-09
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m.
timeFrame: Week 12
Secondary outcomes:
measure: Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m.
timeFrame: Week 24
measure: Number of Counseling Visits Completed
timeFrame: End of 12 week intervention period
measure: Number of Study Visits Completed
timeFrame: 24 weeks
measure: 7-day Point Prevalence Abstinence at 12 Weeks as Verified by Salivary Cotinine.
timeFrame: Weeks 2, 4, 8, 12, and 24
measure: Number of Cigarettes Smoked Per Day
timeFrame: Weeks 2, 4, 8, 12, and 24
measure: Number of Participants With an Attempt to Quit Smoking That Lasted ≥ 24 Hours
timeFrame: Weeks 2, 4, 8, 12, and 24
measure: Confidence in Quitting Smoking (1-10 Scale)
timeFrame: Weeks 2, 4, 8, 12, and 24
measure: Importance of Quitting Smoking (1-10 Scale)
timeFrame: Weeks 2, 4, 8, 12, and 24
measure: Adverse Medication Effects
timeFrame: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
measure: Number of Participants With Severe Global Psychiatric Symptoms Assessed by the Brief Symptom Inventory
timeFrame: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
measure: Number of Patients With Suicial Ideation (Wishes to be Dead, or Thoughts of Killing Self) Assessed Using the Columbia Suicide Severity Scale
timeFrame: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
measure: Number of Participants With Major Depressive Episode, Assessed by the Mini-International Neuropsychiatric Interview
timeFrame: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
measure: Number of Participants With Manic Episode, Assessed by the Mini-International Neuropsychiatric Interview
timeFrame: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
measure: Number of Participants With Psychotic Disorder, Assessed by the Mini-International Neuropsychiatric Interview
timeFrame: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine of Yeshiva University
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Shadi Nahvi, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nahvi S, Ning Y, Segal KS, Richter KP, Arnsten JH. Varenicline efficacy and safety among methadone maintained smokers: a randomized placebo-controlled trial. Addiction. 2014 Sep;109(9):1554-63. doi: 10.1111/add.12631. Epub 2014 Jun 27.