Smoking Cessation Treatment for Methadone Maintenance Patients

Phase 4

Completed

Conditions: Smoking Cessation
Substance-Related Disorders

Interventions: Drug: Varenicline
Drug: Placebo

Registration Number: NCT01027754

Lead Sponsor: Albert Einstein College of Medicine

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 112

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Varenicline	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	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

Primary Outcome Measures

Name	Time	Method
Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m.	Week 12

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Major Depressive Episode, Assessed by the Mini-International Neuropsychiatric Interview	over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
Number of Participants With Psychotic Disorder, Assessed by the Mini-International Neuropsychiatric Interview	over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
Confidence in Quitting Smoking (1-10 Scale)	Weeks 2, 4, 8, 12, and 24	Confidence of quitting smoking measure on a scale of 1-10 (10= high levels of quit confidence).
Adverse Medication Effects	over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
7-day Point Prevalence Abstinence at 12 Weeks as Verified by Salivary Cotinine.	Weeks 2, 4, 8, 12, and 24	Threshold of salivary cotinine ≤ 15 ng/ml was prespecified. Salivary cotinine was measured among participants who self-reported 7-day point prevalence abstinence using a semi-quantitative assay (Nymox NicAlert™).
Number of Study Visits Completed	24 weeks	Mean number of study visit completed out of a possible total of 6 study visits at weeks 0, 2, 4, 8, 12 and 24.
Number of Cigarettes Smoked Per Day	Weeks 2, 4, 8, 12, and 24
Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m.	Week 24
Number of Participants With an Attempt to Quit Smoking That Lasted ≥ 24 Hours	Weeks 2, 4, 8, 12, and 24
Importance of Quitting Smoking (1-10 Scale)	Weeks 2, 4, 8, 12, and 24	Importance of quitting smoking measured on a scale of 1-10 (10=high levels of quit importance).
Number of Participants With Severe Global Psychiatric Symptoms Assessed by the Brief Symptom Inventory	over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
Number of Participants With Manic Episode, Assessed by the Mini-International Neuropsychiatric Interview	over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
Number of Patients With Suicial Ideation (Wishes to be Dead, or Thoughts of Killing Self) Assessed Using the Columbia Suicide Severity Scale	over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
Number of Counseling Visits Completed	End of 12 week intervention period	Participants were offered 5 counseling visits at weeks 0, 2, 4, 8, 12.