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

Yale University

Status and phase: Completed; Phase 2

Conditions: Smoking

Treatments: Drug: placebo; Drug: naltrexone; Drug: varenicline

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00773422

P50AA015632 (U.S. NIH Grant/Contract)

HIC0710003188

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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30 participants in 3 patient groups, including a placebo group

naltrexone + varenicline

Experimental group

Description:

naltrexone (25mg) + varenicline (2mg)

Treatment:

Drug: naltrexone

Drug: varenicline

varenicline

Experimental group

Description:

varenicline 2mg

Treatment:

Drug: varenicline

placebo

Placebo Comparator group

Description:

placebo control

Treatment:

Drug: placebo