Varenicline in Drug Treatment (ViRT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Centre for Addiction and Mental Health
Sponsor:
Collaborator:
Ontario Lung Association
Information provided by (Responsible Party):
Laurie Zawertailo, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT01286584
First received: January 28, 2011
Last updated: March 17, 2014
Last verified: March 2014
  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.

Resource links provided by NLM:


Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • quit smoking rating [ Time Frame: end of 12-week treatment ] [ Designated as safety issue: No ]
    7-day point prevalence


Secondary Outcome Measures:
  • 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 2015 (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:
  • Champix
  • Chantix
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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01286584

Contacts
Contact: Virginia Ittig-Deland, Hon.BA 416-535-8501 ext 77416 virginia.ittigdeland@camh.ca

Locations
Canada, Ontario
Centre for Addiction and Mental Health, Nicotine Dependence Clinic Recruiting
Toronto, Ontario, Canada, M5T 1P7
Sponsors and Collaborators
Centre for Addiction and Mental Health
Ontario Lung Association
Investigators
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: March 17, 2014
Health Authority: Canada: Health Canada

Keywords provided by Centre for Addiction and Mental Health:
varenicline
alcohol
placebo
smoking cessation

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced 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 August 28, 2014