Varenicline in Drug Treatment (ViRT)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Smoking Cessation Alcohol Abuse |
Drug: varenicline Drug: placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Smoking Cessation in a Drug Treatment Program: A Randomized Trial of Varenicline Versus Placebo. |
- quit smoking rating [ Time Frame: end of 12-week treatment ] [ Designated as safety issue: No ]7-day point prevalence
- 30 day continuous smoking abstinence [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | June 2011 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: varenicline group |
Drug: varenicline
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
Other Names:
|
| Placebo Comparator: placebo group |
Drug: placebo
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)
|
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Virginia Ittig-Deland, Hon.BA | 416-535-8501 ext 7416 | virginia_ittigdeland@camh.net |
| Canada, Ontario | |
| Centre for Addiction and Mental Health, Nicotine Dependence Clinic | Recruiting |
| Toronto, Ontario, Canada, M5T 1P7 | |
| Principal Investigator: | Laurie Zawertailo, PhD | Centre for Addiction and Mental Health |
More Information
Additional Information:
No publications provided
| Responsible Party: | Laurie Zawertailo, Independent Scientist, Centre for Addiction and Mental Health |
| ClinicalTrials.gov Identifier: | NCT01286584 History of Changes |
| Other Study ID Numbers: | 144/2010-02 |
| Study First Received: | January 28, 2011 |
| Last Updated: | December 4, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Centre for Addiction and Mental Health:
|
varenicline alcohol placebo smoking cessation |
Additional relevant MeSH terms:
|
Smoking Alcoholism Habits Alcohol-Related Disorders Substance-Related Disorders Mental Disorders Varenicline |
Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013