Varenicline in Drug Treatment (ViRT)
Primary Purpose
Smoking Cessation, Alcohol Abuse
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
varenicline
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Smoking Cessation focused on measuring varenicline, alcohol, placebo, 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
Sites / Locations
- Centre for Addiction and Mental Health, Nicotine Dependence Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
varenicline group
placebo group
Arm Description
Outcomes
Primary Outcome Measures
quit smoking rating
7-day point prevalence
Secondary Outcome Measures
30 day continuous smoking abstinence
Full Information
NCT ID
NCT01286584
First Posted
January 28, 2011
Last Updated
February 3, 2015
Sponsor
Centre for Addiction and Mental Health
Collaborators
Ontario Lung Association
1. Study Identification
Unique Protocol Identification Number
NCT01286584
Brief Title
Varenicline in Drug Treatment
Acronym
ViRT
Official Title
Smoking Cessation in a Drug Treatment Program: A Randomized Trial of Varenicline Versus Placebo.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
Ontario Lung Association
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation, Alcohol Abuse
Keywords
varenicline, alcohol, placebo, smoking cessation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
varenicline group
Arm Type
Active Comparator
Arm Title
placebo group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
varenicline
Other Intervention Name(s)
Champix, Chantix
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
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)
Primary Outcome Measure Information:
Title
quit smoking rating
Description
7-day point prevalence
Time Frame
end of 12-week treatment
Secondary Outcome Measure Information:
Title
30 day continuous smoking abstinence
Time Frame
6-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurie Zawertailo, PhD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health, Nicotine Dependence Clinic
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 1P7
Country
Canada
12. IPD Sharing Statement
Links:
URL
http://www.camh.net/research
Description
Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital. It is fully affiliated with the University of Toronto, and is a PAHO/WHO Collaborating Centre
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Varenicline in Drug Treatment
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