Varenicline in Drug Treatment

Smoking Cessation Clinical Trial

— ViRT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01286584
• Other study ID #: 144/2010-02
• Status: Completed
• Phase: Phase 4
• First received: January 28, 2011
• Last updated: February 3, 2015
• Start date: June 2011
• Est. completion date: September 2014

Study information

• Verified date: February 2015
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Abuse
• Smoking Cessation

Intervention

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
• 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)

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health, Nicotine Dependence Clinic	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health	Ontario Lung Association

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quit smoking rating	7-day point prevalence	end of 12-week treatment	No
Secondary	30 day continuous smoking abstinence		6-month follow-up	No

External Links

•   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