Smoking Cessation Treatment for Methadone Maintenance Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Smoking Cessation Treatment for Methadone Maintenance Patients

Conditions
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Smoking Cessation, Substance-Related Disorders

Intervention / Treatment
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* Drug: Varenicline
* Drug: Placebo


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Varenicline<br>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<br>* 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<br>* Other names: Chantix;|
| Placebo Comparator: Placebo<br>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<br>* Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily<br>* Other names: Matched capsules;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. |  | Week 24 | 
| Number of Counseling Visits Completed | Participants were offered 5 counseling visits at weeks 0, 2, 4, 8, 12. | End of 12 week intervention period | 
| Number of Study Visits Completed | Mean number of study visit completed out of a possible total of 6 study visits at weeks 0, 2, 4, 8, 12 and 24. | 24 weeks | 
| 7-day Point Prevalence Abstinence at 12 Weeks as Verified by Salivary Cotinine. | 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™). | Weeks 2, 4, 8, 12, and 24 | 
| Number of Cigarettes Smoked Per Day |  | Weeks 2, 4, 8, 12, and 24 | 
| Number of Participants With an Attempt to Quit Smoking That Lasted ≥ 24 Hours |  | Weeks 2, 4, 8, 12, and 24 | 
| Confidence in Quitting Smoking (1-10 Scale) | Confidence of quitting smoking measure on a scale of 1-10 (10= high levels of quit confidence). | Weeks 2, 4, 8, 12, and 24 | 
| Importance of Quitting Smoking (1-10 Scale) | Importance of quitting smoking measured on a scale of 1-10 (10=high levels of quit importance). | Weeks 2, 4, 8, 12, and 24 | 
| Adverse Medication Effects |  | over the intervention period (measured at weeks 2, 4, 8, 12, and 24) | 
| 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 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 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 Manic 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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methadone maintenance