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Completed

NCT Number: NCT01286584

Varenicline in Drug Treatment

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre for Addiction and Mental Health, Nicotine Dependence Clinic

Toronto, Ontario, M5T 1P7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Varenicline

Drug

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

Drug

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 outcomes

  1. quit smoking rating

    Time frame: end of 12-week treatment

    7-day point prevalence

Secondary outcomes

  1. 30 day continuous smoking abstinence

    Time frame: 6-month follow-up

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Collaborators

  • Ontario Lung Association

Registry information

Official study title

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

Acronym: ViRT

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jan 31, 2011
Registry last updated
Feb 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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