🏛️ Verified NIH Record • Updated 2026-06-29

Pregnenolone for Cannabis Use Disorder and Depression (NCT07685964)

Advancing Pregnenolone as a Novel Therapy for Co-Occurring Cannabis Use Disorder and Depression

🟡 Not Yet Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: University of Texas Southwestern Medical Center

🩺 Plain-English Summary (8th-Grade Level)

This is UG3 phase of a multi-site, milestone-driven UG3/UH3 research program evaluating pregnenolone for individuals with co-occurring cannabis use disorder (CUD) and major depressive disorder (MDD). Pregnenolone is a neurosteroid that modulates cannabinoid receptor signaling and may reduce cannabis-related effects while also improving mood-related symptoms. The primary objective of the UG3 phase is to establish feasibility and generate preliminary data to support a subsequent UH3 randomized clinical trial. Key preparatory activities include obtaining regulatory approvals (including FDA Investigational New Drug \[IND\] protocol amendment and Institutional Review Board approvals), harmonizing study procedures across participating sites, and implementing data management and monitoring systems. The UG3 phase includes two main components. First, a pharmacokinetic study willcharacterize pregnenolone pharmacokinetics in adults with CUD and MDD, including measures such as half-life and clearance. Second, a pilot clinical study will evaluate the feasibility, safety, and tolerability of pregnenolone administered orally over approximately 12 weeks. Feasibility outcomes include recruitment rates, retention, and adherence to study procedures, while safety and tolerability will be assessed through adverse event monitoring and discontinuation rates. Participants will be adults aged 18 to 50 years with diagnoses of cannabis use disorder and major depressive disorder, who report frequent cannabis use and express interest in reducing their use. Clinical assessments of cannabis use, mood symptoms, and related behavioral outcomes will be collected. The UG3 phase will be used to refine study procedures, inform dosing strategies, and establish benchmarks necessary for progression to the UH3 phase. The subsequent UH3 phase will involve a multi-site, randomized, double-blind, placebo-controlled trial evaluating the efficacy of pregnenolone in reducing cannabis use and improving depressive symptoms in this population.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (9 items).

Location: UT Southwestern Medical Center — Dallas, Texas

Age range: 18 Years to 50 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Current diagnosis of other substance use disorders (except nicotine)
  • Current or past diagnosis of psychotic disorders, bipolar disorder, or severe psychiatric conditions
  • Significant or unstable medical conditions that would interfere with study participation
  • Pregnant or breastfeeding
  • Active suicidal or homicidal ideation requiring immediate intervention
  • Use of medications that may interfere with study drug or outcomes, unless stable
  • Allergy or sensitivity to pregnenolone or related compounds
  • History of hormone-sensitive cancer or tumor

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

  • UT Southwestern Medical Center — Dallas, Texas
  • University of Texas at Dallas — Richardson, Texas

📞 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.

💰 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 § 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.

More studies in Cannabis Use Disorder

Explore by condition: All Cannabis Use Disorder clinical trials

💡 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.
🏛️ View Official NIH Record ↗