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

Phase 2

Completed

• Conditions: Smoking
• Interventions: Drug: placebo; Drug: naltrexone; Drug: varenicline

• Registration Number: NCT00773422
• Lead Sponsor: Yale University

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 and also subsequent ad-lib smoking, following a low-dose alcohol priming drink, in non-treatment seeking alcohol-drinking daily smokers.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-10-14
• Study First Submitted QC: 2008-10-15
• Study First Posted: 2008-10-16
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Results First Submitted: 2018-02-21
• Status Verified: 2018-03
• Results First Submitted QC: 2018-03-22
• Last Update Submitted: 2018-03-22
• Results First Posted: 2018-04-23
• Last Update Posted: 2018-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	placebo control
naltrexone + varenicline	naltrexone	naltrexone (25mg) + varenicline (2mg)
naltrexone + varenicline	varenicline	naltrexone (25mg) + varenicline (2mg)
varenicline	varenicline	varenicline 2mg

Primary Outcome Measures

Name	Time	Method
Latency to Initiate Ad-lib Smoking Session	day 8	Time to smoking during the smoking delay task. Smoking delay task occurred on day 8 of the study. Range of time delay is 0 minutes to 50 minutes.

Secondary Outcome Measures

Name	Time	Method
Number of Cigarettes Smoked During the Ad-lib Period	day 8	Number of cigarettes smoked during the ad libitum phase of the smoking delay task. Task occurred on day 8 of the study.

Trial Locations

Locations (1)

Yale Center for Clinical Investigation, Yale University; 🇺🇸 New Haven, Connecticut, United States