The Effect of Naltrexone and Varenicline on Alcohol-Mediated Smoking Lapse
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Yale University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Latency to Initiate Ad-lib Smoking Session
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
naltrexone + varenicline
naltrexone (25mg) + varenicline (2mg)
Intervention: naltrexone (Drug)
naltrexone + varenicline
naltrexone (25mg) + varenicline (2mg)
Intervention: varenicline (Drug)
varenicline
varenicline 2mg
Intervention: varenicline (Drug)
placebo
placebo control
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Latency to Initiate Ad-lib Smoking Session
Time Frame: 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 Outcomes
- Number of Cigarettes Smoked During the Ad-lib Period(day 8)
Investigators
Sherry McKee
Associate Professor of Psychiatry
Yale University