← Back to Search

Pregnenolone for Alcoholism

Phase 2

Recruiting

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Study Summary

This trial will test if a drug (PREG) may help people with Alcohol Use Disorder (AUD) over a 12 week period.

Who is the study for?

This trial is for English-speaking adults aged 18-70 with Alcohol Use Disorder, confirmed by a positive alcohol test or reports from close contacts. Participants must consent to the study's procedures. Pregnant or nursing women, individuals not using effective birth control, opiate users, those on psychoactive drugs including anxiolytics, naltrexone or antabuse, and people with severe medical conditions or low blood pressure are excluded.Check my eligibility

What is being tested?

The trial tests Pregnenolone (300 mg/day) against a placebo over 12 weeks plus follow-up in treating Alcohol Use Disorder. It's a Phase 2 randomized controlled trial where participants are randomly assigned to receive either the hormone treatment or an inactive substance without knowing which one they're getting.See study design

What are the potential side effects?

While specific side effects of pregnenolone at this dose aren't detailed here, potential risks may include hormonal imbalances leading to mood changes, headaches, fatigue and possibly other symptoms related to altering steroid hormone levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent of Subjects with no Heavy Drinking Days

Safety of pregnenolone

Secondary outcome measures

Average Drinks per Day

Percent Any Drinking Days

Percent Heavy Drinking Days

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: patients receiving 300mg PREGActive Control1 Intervention

Patients randomly assigned to receive 300mg of pregnenolone (PREG) daily.

Group II: placeboPlacebo Group1 Intervention

Patients randomly assigned to receive a placebo daily.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,853 Previous Clinical Trials

2,738,411 Total Patients Enrolled

84 Trials studying Alcoholism

10,229 Patients Enrolled for Alcoholism

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH

802 Previous Clinical Trials

1,365,295 Total Patients Enrolled

424 Trials studying Alcoholism

985,718 Patients Enrolled for Alcoholism

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05781009 — Phase 2

Alcoholism Research Study Groups: patients receiving 300mg PREG, placebo

Alcoholism Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05781009 — Phase 2

Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05781009 — Phase 2

Frequently Asked Questions

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

Are those aged 35 and younger being considered for admission to this medical study?

"This medical study has an upper enrollment limit of 70 years old and a lower age restriction of 18."

Answered by AI

Are there any eligibility criteria that must be met to join this experiment?

"For this particular trial, it is compulsory that individuals have a history of alcohol abuse and are aged between 18-70 years old. In total, the study requires 150 volunteers to participate."

Answered by AI

Can participants still join this research project?

"According to clinicaltrials.gov, this experiment is no longer recruiting participants - the trial was first published on July 1st 2023 and last modified on March 10th 2023. Nevertheless, there are still 372 other medical studies actively seeking patients in need of treatment."

Answered by AI

What possible health risks can manifest in those who take 300mg PREG?

"Our assessments at Power rank the safety of administering 300mg PREG to patients, who are partaking in a Phase 2 trial as a 2 due to there being limited data on efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pregnenolone for the Treatment of Alcohol Use Disorder

2024. "Pregnenolone for the Treatment of Alcohol Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05781009.