๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-20

Pregnenolone Treatment for Alcohol Use Disorder and Major Depressive Disorder (NCT07734701)

Targeting Neurosteroid Pathways in Alcohol Use Disorder: Clinical and Neural Impact of Pregnenolone Therapy

๐ŸŸก Not Yet Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Sherwood Brown, MD, PhD

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: UT Southwestern Medical Center โ€” Dallas, Texas

Age range: 21 Years to 55 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (2 Sites)

  • UT Southwestern Medical Center โ€” Dallas, Texas
  • University of Texas at Dallas โ€” Richardson, Texas

๐Ÿ“ž Contact the Study Coordinator

Phone: (214) 645-6950

Email: SHERWOOD.BROWN@UTSouthwestern.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—