Clinical trial NCT01286584: Varenicline in Drug Treatment
Official title: Smoking Cessation in a Drug Treatment Program: A Randomized Trial of Varenicline Versus Placebo.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking Cessation
Alcohol Abuse
Keywords: varenicline
alcohol
placebo
smoking cessation
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: Ontario Lung Association
First posted: 2011-01-31
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: quit smoking rating
timeFrame: end of 12-week treatment
Secondary outcomes:
measure: 30 day continuous smoking abstinence
timeFrame: 6-month follow-up
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health, Nicotine Dependence Clinic
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Laurie Zawertailo, PhD
role: PRINCIPAL_INVESTIGATOR
References: