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Neurosteroid

allopregnanolone for Alcoholism

Phase 1
Waitlist Available
Led By Elizabeth Ralevski, PhD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Non-treatment seeking individuals with current DSM-5 AUD
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes
Awards & highlights

Study Summary

This trial will test whether allopregnanolone can help heavy drinkers by reducing stress-induced cravings and anxiety.

Eligible Conditions
  • Alcoholism

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are not currently seeking treatment for alcohol use disorder (AUD) as defined by the DSM-5.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Alcohol Urge Questionnaire (AUQ)
The State-Trait Anxiety Inventory (STAI-6)
Secondary outcome measures
Biphasic Alcohol Effects scale (BAES)

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: allopregnanoloneActive Control1 Intervention
allopregnanolone
Group II: placeboPlacebo Group1 Intervention
placebo

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,830 Previous Clinical Trials
2,727,137 Total Patients Enrolled
81 Trials studying Alcoholism
10,222 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
783 Previous Clinical Trials
1,355,473 Total Patients Enrolled
413 Trials studying Alcoholism
982,835 Patients Enrolled for Alcoholism
Elizabeth Ralevski, PhDPrincipal InvestigatorYale University

Media Library

Allopregnanolone (Neurosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04015869 — Phase 1
Alcoholism Research Study Groups: allopregnanolone, placebo
Alcoholism Clinical Trial 2023: Allopregnanolone Highlights & Side Effects. Trial Name: NCT04015869 — Phase 1
Allopregnanolone (Neurosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04015869 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this medical trial open to individuals under 35 years of age?

"The given inclusion criteria indicates that prospective participants must be between the age of 21 and 50."

Answered by AI

Am I eligible to enroll in this clinical experiment?

"This study is enrolling 60 individuals between the ages 21 and 50 who have an alcohol use disorder. In addition to this, further requirements for enrolment include being non-treatment seeking with a DSM-5 AUD diagnosis, not having any extra substance abuse issues apart from tobacco, alcohol and marijuana, no medical concerns or abnormal ECG readings as well as women needing to be pregnancy screened before joining in."

Answered by AI

Is the enrollment period for this trial open?

"Affirmative. Clinicaltrials.gov reveals that this trial has been accepting recruits since July 1st 2019 and is still actively seeking new patients as of October 20th 2022, with the goal of enrolling 60 people at a single site."

Answered by AI

Has the Federal Drug Administration authorized allopregnanolone for use?

"The safety of allopregnanolone is rated a 1 due to it being in Phase 1 trials, meaning there is only minimal information on its efficacy and the risk-benefit ratio."

Answered by AI

How many participants is the maximum capacity of this clinical trial?

"Affirmative. As per clinicaltrials.gov, this medical trial is currently recruiting patients and was initially made public on the 1st of July 2019 before being revised lastly on October 20th 2022. The study demands 60 participants from a single site."

Answered by AI
~3 spots leftby Feb 2025