Varenicline in Drug Treatment

Study Overview
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Brief Summary
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The aim of this study is to assess the efficacy of varenicline compared to placebo in tobacco dependent individuals who are undergoing concurrent treatment for alcohol dependence. As they will be inpatients and under 24 hour medical care for the first 21 days of treatment, or receiving outpatient treatment through the Alcohol Research and Treatment Clinic, this will allow for a comprehensive assessment of the safety of varenicline in this population with minimal risk of adverse consequences. The patients will continue their cessation treatment for an additional 10 weeks as outpatients through the Nicotine Dependence Clinic at CAMH. They will also be contacted at 6 months for follow-up.

Detailed Description
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Drinking alcohol and cigarette smoking are closely associated and use of one often leads to the use of the other. Also, since tobacco-related illness is the number one cause of death among recovered alcoholics it is imperative that we provide strong evidence-based treatment options for this population. Since smoking can be a strong trigger to drink in those who are dependent on both alcohol and tobacco, treating both at the same time may result in better treatment outcomes. This study will examine the efficacy of starting smoking cessation treatment while patients are in residential treatment for alcohol dependence, or outpatient in the Alcohol Research and Treatment Clinic. It will compare the effectiveness of varenicline, the most effective medication for smoking cessation with placebo. Both groups will receive weekly cessation counselling and support by a trained research analyst. We will measure abstinence from smoking at the end of the 12-week treatment period and again after 6-months to determine longer-term smoking cessation.

Official Title
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Smoking Cessation in a Drug Treatment Program: A Randomized Trial of Varenicline Versus Placebo.

Conditions
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Smoking Cessation, Alcohol Abuse

Intervention / Treatment
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* Drug: varenicline
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: current daily smokers enrolled in residential treatment or outpatient in Alcohol Treatment and Research Clinic for Alcohol Use Disorder at CAMH smoke minimum of 10 cigarettes per day Fagerstrom Test of Nicotine Dependence score > 3 able to provide written informed consent able and willing to attend weekly appointments at the NDC following discharge Exclusion Criteria: any serious medical condition requiring immediate investigation or treatment pregnancy or lactation current DSM-IV Axis I psychiatric disorder any know contraindication to using varenicline

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: varenicline group<br> | Drug: varenicline<br>* one 0.5mg varenicline capsule on first 3 days one 0.5mg varenicline capsule, twice daily for 4 days one 1.0mg varenicline capsule, twice daily until end of treatment (12weeks of medication<br>* Other names: Chantix;|
| Placebo Comparator: placebo group<br> | Drug: placebo<br>* lactose filler in capsules identical to the varenicline capsules one 0.5mg capsule for 3 days one 0.5mg capsule twice daily for 4 days one 1.0mg capsule twice daily until end of treatment (12weeks of medication)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quit smoking rating | 7-day point prevalence | end of 12-week treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 day continuous smoking abstinence |  | 6-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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varenicline, alcohol, placebo, smoking cessation