Effect of Allopregnanolone on Stress-induced Craving

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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 secondary objective of this project is to characterize the behavioral effects of ALLO in heavy drinkers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Pregnanolone

Criteria

Inclusion Criteria:

• Non-treatment seeking individuals with current DSM-5 AUD

• No current substance use disorder (except tobacco, alcohol, and marijuana)

• No current medical problems and normal ECG

• For women, not pregnant as determined by pregnancy screening, not breast feeding.

Exclusion Criteria:

• 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