The Effect of Naltrexone and Varenicline on Alcohol-Mediated Smoking Lapse
Completed · Phase 2 · Has a placebo group
Conditions studied: Smoking
In brief
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 and also subsequent ad-lib smoking, following a low-dose alcohol priming drink, in non-treatment seeking alcohol-drinking daily smokers.
Key facts
- Study ID
- NCT00773422
- Run by
- Yale University
- People needed
- 30
- Starts
- 2008-01-01
- Expected to finish
- 2016-11-01
- Last updated by the study team
- 2018-04-23
Who can join
Age: 21 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ages 21-55
- ability to read and write in English
- alcohol-drinking smokers
You may not qualify if…
- 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
Where it is running
- Yale Center for Clinical Investigation, Yale University — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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