Pregnenolone Treatment for Alcohol Use Disorder and Major Depressive Disorder

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-55
SponsorSherwood Brown, MD, PhD

About this trial

This study will evaluate whether pregnenolone is an effective treatment for adults with Alcohol Use Disorder (AUD) and Major Depressive Disorder (MDD). Participants will be randomly assigned to receive either pregnenolone or placebo for 12 weeks in a double-blind study. Researchers will assess alcohol consumption, alcohol craving, depressive symptoms, and anxiety symptoms throughout treatment. The study will also use magnetic resonance imaging (MRI) to examine how pregnenolone affects brain circuits involved in addiction and mood regulation. The goal is to determine whether pregnenolone can improve both alcohol-related and mood-related outcomes and to identify the neural mechanisms associated with treatment response.

Eligibility criteria

Qualifiers

Age 21 to 55 years.

Meets DSM-5 criteria for Alcohol Use Disorder (AUD).

Meets DSM-5 criteria for Major Depressive Disorder (MDD).

Able to provide informed consent.

Disqualifiers

Current diagnosis of bipolar disorder, schizophrenia spectrum disorder, or other psychotic disorder.

Current substance use disorder requiring immediate treatment other than alcohol or nicotine.

Significant unstable medical or neurologic illness that would interfere with participation or study assessments.

Contraindications to magnetic resonance imaging (MRI).

Trial design

Treatments tested in this trial

  • Pregnenolone
  • Placebo

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Sherwood Brown, MD, PhD

Lead sponsor

University of Texas Southwestern Medical Center

Sponsor institution

The University of Texas at Dallas

Collaborator

Duke University

Collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator