Status:
COMPLETED
Effect of Allopregnanolone on Stress-induced Craving
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
21-50 years
Phase:
PHASE1
Brief Summary
The goal of this study is to determine whether intravenous infusion of allopregnanolone (ALLO) attenuates stress-induced craving and stress-induced anxiety in a clinical laboratory setting. The second...
Detailed Description
This is a double-blind, placebo-controlled study that will randomize heavy "at risk" drinkers to 2 groups: targeted dose of 100 nM of ALLO or placebo. Participants will receive a continuous infusion o...
Eligibility Criteria
Inclusion
- Non-treatment seeking individuals with current Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) alcohol use disorder (AUD)
- No current substance use disorder (except tobacco, alcohol, and marijuana)
- No current medical problems and normal electrocardiogram (ECG)
- For women, not pregnant as determined by pregnancy screening, not breast feeding.
Exclusion
- Current major psychiatric illnesses including mood, psychotic, or anxiety disorders
- History of major medical illnesses; including liver diseases, heart disease, chronic pain or other medical conditions that the physician investigator deems contraindicated for the subject to be in the study
- Liver function tests (ALT or AST) greater than 3 times normal
- weight \>120kg
- renal impairment
- patients on the following medications: a) medications for alcoholism (e.g. naltrexone, disulfiram, topiramate, acamprosate); b) psychotropic medications that promote sedation (please note patients on psychotropic medications for current psychiatric conditions will also be excluded); and c) patients currently taking antibiotics or antifungals
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04015869
Start Date
July 1 2019
End Date
September 1 2023
Last Update
August 22 2025
Active Locations (1)
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1
VA Connecticut Healtcase System
West Haven, Connecticut, United States, 06516