Overview

Varenicline in Drug Treatment

Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Centre for Addiction and Mental Health
Collaborator:
Ontario Lung Association
Treatments:
Varenicline
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