Status:
COMPLETED
Effect of Varenicline on Reactivity to Smoking and Drinking Cues
Lead Sponsor:
Centre for Addiction and Mental Health
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Tobacco Dependence
Alcohol Dependence
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Alcohol and nicotine dependence are often co-morbid, with 85% of alcoholics also smoking. However, very little research has been conducted into the nature of this co-occurrence. Thus, the main aim of ...
Detailed Description
The relationship between alcohol and tobacco dependence needs to be addressed as such populations are generally excluded from clinical trials involving smoking cessation pharmacotherapy. Furthermore, ...
Eligibility Criteria
Inclusion
- Inclusion Criteria: Heavy Smokers/Heavy Drinkers
- Treatment seeking smokers
- Age 18 to 65 years
- Smoke ≥ 10 cigarettes per day
- Fagerstrom Test of Nicotine Dependence score \> 3
- Alcohol Use Disorders Identification Test (AUDIT) \> 8
- Drink \> 25 drinks per week for males or \> 20 drinks per week for females
- Able to provide written informed consent
- Inclusion Criteria (Heavy Smokers/Social Drinkers):
- Treatment seeking smokers
- Age 18 to 65 years
- Smoke ≥ 10 cigarettes per day
- Fagerstrom Test of Nicotine Dependence score \> 3
- Alcohol Use Disorders Identification Test(AUDIT) \< 8
- Drink \< 14 drinks per week for males or \< 9 drinks per week for females
- Able to provide written informed consent
- Exclusion Criteria (Heavy Smokers/Heavy Drinkers):
- Any medical condition requiring immediate investigation or treatment
- Beck Depression Inventory score \>16
- Insulin-dependent diabetes
- Drink \> 70 standard alcoholic drinks per week for males or drink \> 52 standard alcoholic drinks per week for females
- Pregnancy or lactation
- Current DSM-IV Axis 1 psychiatric disorder
- Regular use of any therapeutic or recreational psychoactive drug use during the last three months or other substance use disorder, with the exception of tobacco and alcohol.
- Exclusion Criteria (Heavy Smokers/Social Drinkers):
- Any medical condition requiring immediate investigation or treatment
- Beck Depression Inventory score \>16
- Insulin-dependent diabetes
- Drink \> 14 standard alcoholic drinks per week for males or \> 9 standard alcoholic drinks per week for females
- Pregnancy or lactation
- Current DSM-IV Axis 1 psychiatric disorder
- Regular use of any therapeutic or recreational psychoactive drug use during the last three months or other substance use disorder, with the exception of tobacco.
Exclusion
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00873535
Start Date
October 1 2008
End Date
January 1 2010
Last Update
September 7 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5S 2S1