Viewing Study NCT05781009



Ignite Creation Date: 2024-05-06 @ 6:47 PM
Last Modification Date: 2024-10-26 @ 2:54 PM
Study NCT ID: NCT05781009
Status: RECRUITING
Last Update Posted: 2024-06-11
First Post: 2023-03-10

Brief Title: Pregnenolone for the Treatment of Alcohol Use Disorder
Sponsor: Yale University
Organization: Yale University

Study Overview

Official Title: Pregnenolone for the Treatment of Alcohol Use Disorder
Status: RECRUITING
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This Phase 2 randomized cotrolled trial RCT will assess the safety and efficacy of pregnenolone PREG 300 mgday bid dosing vs placebo PBO over a 12 week treatment period and at 1-month post-treatment follow-up in individuals with Alcohol Use Disorder AUD
Detailed Description: In this Phase 2 single-site randomized controlled trial RCT men and women with Alcohol Use Disorder AUD will be enrolled in a 12 week trial with a 1-month follow-up assessment Participants will be randomly assigned to 300mg pregnenolone PREG treatment bid or Placebo PBO All participants will be assessed 2x weekly and also receive behavior counseling to support recovery The study aims to examine a the safety and tolerability b efficacy on alcohol use outcomes and c effects on alcohol craving anxiety depression and physical well-being of 300mg PREG vs PBO in men and women with AUD over the 12-week treatment period and at the 1-month follow up post-treatment period

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: True
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
1R01AA030923-01 NIH None httpsreporternihgovquickSearch1R01AA030923-01