Pregnenolone for Cannabis Use Disorder and Depression
(PREG-CUD-MDD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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 Is on the Research Team?
E. Sherwood Brown
Principal Investigator
University of Texas Southwestern Medical Center
Are You a Good Fit for This Trial?
This trial is for adults aged 18 to 50 who have both major depression and cannabis use disorder. Participants must use cannabis frequently and want to cut down their use.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Pregnenolone
Trial Overview
The study is testing pregnenolone, a neurosteroid taken by mouth, to see if it can help people with both depression and heavy cannabis use. The first phase checks how the body processes the drug and whether it's safe over about 12 weeks.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas Southwestern Medical Center
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
The University of Texas at Dallas
Collaborator
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