Centre for Addiction and Mental Health, Nicotine Dependence Clinic
Toronto, Ontario, M5T 1P7, Canada
NCT Number: NCT01286584
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.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Phase 4
Toronto, Ontario, M5T 1P7, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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)
Time frame: end of 12-week treatment
7-day point prevalence
Time frame: 6-month follow-up
Centre for Addiction and Mental Health
Other
Smoking Cessation in a Drug Treatment Program: A Randomized Trial of Varenicline Versus Placebo.
Acronym: ViRT
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.
Published trials that share one or more normalized conditions with this study.
NCT05729243
Alcohol Use Disorder, Alcohol-Related Disorders
Toronto, Ontario, Canada
View Trial DetailsNCT06663020
Behavior, Bronchial Neoplasms
Samsun, Turkey (Türkiye)
View Trial DetailsNCT04881630
Behavior, Health Behavior
Oklahoma City, Oklahoma, United States
View Trial DetailsNCT04620915
Behavior, Cancer
Eugene, Oregon, United States
View Trial Details