Pregnenolone for the Treatment of Alcohol Use Disorder

NCT05781009 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2000034929R01AA030923
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Percent of Subjects with no Heavy Drinking Days

  Pregnenolone versus Placebo treated subjects will be compared on any days of heavy drinking which is defined by 5 or more drinks per day in men and 4 or more drinks/day in women. This will be measured by the Percent of Subjects with no Heavy Drinking Days (PSNHDD) over a 12 week period.

  12 weeks

• Safety of pregnenolone

  The Systematic Assessment of Treatment Emergent Events (SAFTEE) Questionnaire will be used to assess adverse events weekly during the trial.

  12 weeks

Secondary Outcomes (3)

• Percent Heavy Drinking Days

  12 weeks

• Percent Any Drinking Days

  12 weeks

• Average Drinks per Day

  12 weeks

Study Arms (2)

patients receiving 300mg PREG

ACTIVE COMPARATOR

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

Drug: Pregnenolone

placebo

PLACEBO COMPARATOR

Patients randomly assigned to receive a placebo daily.

Drug: Placebo

Interventions

Pregnenolone DRUG

300mg

patients receiving 300mg PREG

Placebo DRUG

placebo

placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Able to read English and complete study evaluations;
• Able to provide informed written and verbal consent.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Yale University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

The Yale Stress Center: Yale University

New Haven, Connecticut, 06519, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism

Interventions

Pregnenolone

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Central Study Contacts

Verica Milivojevic, PhD

CONTACT

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

Rajita Sinha, PHD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Double-blind, placebo-controlled, parallel design

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: March 23, 2023
• Study Start: January 8, 2024
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

US (1)