Status:
COMPLETED
The Effect of Naltrexone and Varenicline on Alcohol-Mediated Smoking Lapse
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Smoking
Eligibility:
All Genders
21-55 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to examine how medications thought to attenuate the effects of alcohol (naltrexone) and smoking cessation medications (varenicline) affect the ability to resist smoking an...
Eligibility Criteria
Inclusion
- ages 21-55
- ability to read and write in English
- alcohol-drinking smokers
Exclusion
- any significant current medical conditions that would contraindicate smoking
- current DSM-IV abuse or dependence of other substances, other than nicotine dependence or alcohol abuse.
- positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines
- women who are pregnant or nursing
- suicidal, homicidal or evidence of current severe mental illness
- participants prescribed any psychotropic drug in the 30 days prior to study enrollment
- blood donation within the past 6 weeks
- individuals seeking treatment for smoking cessation or drinking or have attempted to quit smoking or drinking within the past 3 months
- specific exclusion for administration of naltrexone not specified above including chronic pain conditions necessitating opioid treatment, and evidence of significant hepatocellular injury as evidenced by SGOT or SGPT \> 3x normal or elevated bilirubin
- known allergy to varenicline or taking H2blockers (e.g., Cimetidine)
- participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current protocol
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00773422
Start Date
January 1 2008
End Date
November 1 2016
Last Update
April 23 2018
Active Locations (1)
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1
Yale Center for Clinical Investigation, Yale University
New Haven, Connecticut, United States, 06519