Overview

This trial has been completed.

Condition smoking
Treatments naltrexone, varenicline, placebo
Phase phase 2
Sponsor Yale University
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model factorial assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
naltrexone (25mg) + varenicline (2mg)
naltrexone
25 mg/day, with 1-week lead-in medication period. The starting dose is 0 mg/day for days 1-3, followed by 12.5mg/day for day 4, followed by 25mg/day for days 5-7, plus during the laboratory session (day 8).
varenicline Chantix
2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8).
(Experimental)
varenicline 2mg
varenicline Chantix
2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8).
(Placebo Comparator)
placebo control
placebo
placebo

Primary Outcomes

Measure
latency to initiate ad-lib smoking session
time frame: in the laboratory session

Secondary Outcomes

Measure
number of cigarettes smoked during the ad-lib period
time frame: during the laboratory session

Eligibility Criteria

Male or female participants from 21 years up to 55 years old.

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

Additional Information

Official title The Effect of Naltrexone and Varenicline on Alcohol-Mediated Smoking Lapse
Principal investigator Sherry A McKee, PhD
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Yale University.