Pregnenolone for Cannabis Use Disorder and Depression

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT07685964
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Cannabis Use Disorder
  • Major Depressive Disorder (MDD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Pregnenolone — DRUG
    Pregnenolone is a neurosteroid administered orally. It is being studied for its pharmacokinetics, safety, tolerability, and feasibility in adults with cannabis use disorder and major depressive disorder.

Study Details

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.

Key Dates

Start date
Sep 30, 2026
Status verified
Jun 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pregnenolone 300mg/d
    Participants receive pregnenolone 300mg/d administered orally for approximately 12 weeks. The study will evaluate pharmacokinetics, safety, tolerability, and feasibility in adults with cannabis use disorder and major depressive disorder.
  • Experimental: Pregnenolone 500mg/d
    Participants receive pregnenolone 500mg/d administered orally for approximately 12 weeks. The study will evaluate pharmacokinetics, safety, tolerability, and feasibility in adults with cannabis use disorder and major depressive disorder.

Primary Outcome Measure

Percent Days of Cannabis Use [ Time Frame: 12 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
UT Southwestern Medical CenterDallasTexas75390
E. Sherwood Brown
[email protected]
214-645-6950
Reagan Volzer
[email protected]
University of Texas at DallasRichardsonTexas75080
Francesca Filbey
[email protected]
972-883-2313
Aishwarya Veerkumar
[email protected]
972-742-5842
Francesca Filbey (PRINCIPAL_INVESTIGATOR)

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