Recruiting
Phase 2

Pregnenolone

Sponsor:

Yale University

Code:

NCT05781009

Conditions

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Pregnenolone

Placebo

Study Details

Brief summary:

This Phase 2 randomized cotrolled trial (RCT) will assess the safety and efficacy of pregnenolone (PREG; 300 mg/day, b.i.d 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).

Conditions

Alcohol Use Disorder

Study ID

NCT05781009

Start date

Jan 8, 2024

Status verified date

Jan, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male and females, aged 18-70 years;
  • Regular weekly use of alcohol at least 3X weekly or more at treatment entry;
  • Must meet current DSM-5 criteria for moderate to severe Alcohol Use Disorders (AUDs) using SCID-I for DSM-5;
  • No health conditions that would impact trial participation as verified by screening and physical examination and absence of any of the exclusion criterions outlined below;
  • Able to read English and complete study evaluations;
  • Able to provide informed written and verbal consent.

Exclusion Criteria:

  • Meet current criteria for moderate to severe substance use disorders from use of any other psychoactive substance, excluding nicotine and cannabis use disorder;
  • Current use of opioids;
  • Regular use of anticonvulsants, sedatives or hypnotics, oral prescription analgesics (other than non-steroidal anti-inflammatory drugs), topiramate, baclofen;
  • Regular use of steroidal supplements and steroid medications interacting with study medications based on clinical judgement of study physician (excluding hormonal contraceptives in women);
  • Psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal, current mania);
  • Significant underlying medical conditions such as cerebral, renal, thyroid or cardiac pathology which in the opinion of study physician would preclude patient from fully cooperating or be of potential harm during the course of the study, but stable, prescribed anti-hypertensives. cardiovascular and diabetes medications will be allowed after review by study physician;
  • Any psychotic disorder or current Axis I psychiatric disorders requiring specific acute attention, including need for psychiatric medications, but stable, prescribed antidepressants and anti-anxiety medication to treat co-occurring psychiatric disorders will be allowed;
  • Women who are pregnant, nursing or refuse to use a reliable form of birth control (as assessed by urine pregnancy tests during initial medical evaluation, and assessed every two weeks during the course of the study).

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: patients receiving 300mg PREG

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

placebo comparator: placebo

Patients randomly assigned to receive a placebo daily.

Interventions

Pregnenolone

300mg

Placebo

placebo

Primary outcome measure

  • Percent of Subjects with no Heavy Drinking Days [ Time Frame: 12 weeks ]
  • Safety of pregnenolone [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Verica Milivojevic, PhD

203-737-1176verica.milivojevic@yale.edu

Rajita Sinha, PHD

203-737-5805rajita.sinha@yale.edu

Locations

The Yale Stress Center: Yale University

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Rachel Hart, MS

203-737-4791rachel.hart@yale.edu

Verica Milivojevic, PhD

12037371176verica.milivojevic@yale.edu

Principal Investigator:

Verica Milivojevic, PhD

More Information

Sponsor

Yale University

Last update posted

Feb 2, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-02-02.