The Effect of Naltrexone and Varenicline on Alcohol-Mediated Smoking Lapse



Status:Completed
Conditions:Smoking Cessation
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:21 - 55
Updated:4/25/2018
Start Date:January 2008
End Date:November 2016

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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.


Inclusion Criteria:

- ages 21-55

- ability to read and write in English

- alcohol-drinking smokers

Exclusion Criteria:

- 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
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