The Effect of Naltrexone and Varenicline on Alcohol-Mediated Smoking Lapse
This trial has been completed.
|Treatments||naltrexone, varenicline, placebo|
|Collaborator||National Institute on Alcohol Abuse and Alcoholism (NIAAA)|
|Start date||January 2008|
|End date||November 2016|
|Trial size||30 participants|
|Trial identifier||NCT00773422, HIC0710003188, P50AA015632|
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.
|Intervention model||factorial assignment|
|Masking||double blind (subject, investigator, outcomes assessor)|
latency to initiate ad-lib smoking session
time frame: in the laboratory session
number of cigarettes smoked during the ad-lib period
time frame: during the laboratory session
Male or female participants from 21 years up to 55 years old.
- ages 21-55
- ability to read and write in English
- alcohol-drinking smokers
- 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
|Official title||The Effect of Naltrexone and Varenicline on Alcohol-Mediated Smoking Lapse|
|Principal investigator||Sherry A McKee, PhD|
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