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Not yet recruitingPhase 1 / Phase 2

Pregnenolone for Cannabis Use Disorder and Depression

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 50 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Second, a pilot clinical study will evaluate the feasibility, safety, and tolerability of pregnenolone administered orally over approximately 12 weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This early study tests how the body processes pregnenolone and how safe it is to take by mouth for about 12 weeks. It is for adults ages 18 to 50 who have trouble controlling cannabis use and have major depression. The results will help plan a larger study on whether pregnenolone can reduce cannabis use and improve mood.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 18 to 50 years old.
  • Have a diagnosis of cannabis use disorder, or trouble controlling cannabis use.
  • Have a diagnosis of major depression.
  • Used cannabis at least 4 days a week during the past 4 weeks.
  • Have a urine test that shows THC, the substance in cannabis that causes a high.
  • Are willing to reduce cannabis use.
  • Take no medicine or take a steady dose of medicine for depression.
  • Can understand the study and agree to take part.

Who can't join

  • Currently have another substance use disorder, except nicotine use disorder.
  • Have or have had a psychotic disorder (trouble knowing what is real), bipolar disorder, or another severe mental health condition.
  • Have a serious or unstable health condition that would make it hard to take part.
  • Are pregnant or breastfeeding.
  • Have thoughts of suicide or harming others that need help right away.
  • Take medicines that may affect the study drug or results, unless their use is stable.
  • Are allergic or sensitive to pregnenolone or similar substances.
  • Have had cancer or a tumor whose growth is affected by hormones.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Adults aged 18 to 50 years * Diagnosis of cannabis use disorder according to DSM-5 criteria * Diagnosis of major depressive disorder according to DSM-5 criteria * Cannabis use on at least 4 days per week in the past 4 weeks * Positive urine screen for tetrahydrocannabinol (THC) * Willingness to reduce cannabis use * Medication-free or on a stable dose of antidepressant medication * Able to provide informed consent 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

Study sites (2)

TX