Pregnenolone for Cannabis Use Disorder and Depression

This study is looking at an oral medication called Pregnenolone for adults who have both cannabis use disorder and major depressive disorder. Pregnenolone is a neurosteroid, which means it's a natural chemical in the brain that might help reduce the effects of cannabis and improve mood. We want to see how the body handles Pregnenolone, if it's safe, and if people can tolerate taking it. To join, you need to be between 18 and 50 years old, have both conditions, use cannabis at least 4 days a week, and be willing to reduce your cannabis use. The main goal is to see how many days you use cannabis over 12 weeks.

Study design
This is an interventional study with a planned enrollment of 20 participants. It is the first part of a larger research program.
What's involved
You would take Pregnenolone orally for about 12 weeks. The study will also look at how your body processes the medication.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, percent days of cannabis use, is measured at 12 weeks.

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NCT07685964

Pregnenolone for Cannabis Use Disorder and Depression

Not Yet Recruiting
PHASE1Ages 18–50InterventionalTreatment
University of Texas Southwestern Medical Center
~20 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:Pregnenolone

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent Days of Cannabis Use
Measured over 12 weeks
Cannabis Use Disorder
Major Depressive Disorder (MDD)
2 sites across 1 states
Texas2
  • E. Sherwood Brown · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

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Eligibility criteria

Inclusion

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

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
  • Percent Days of Cannabis Use12 weeks

    The Timeline Follow Back (TLFB) interview will be used to assess cannabis use. The percent days of cannabis use will be the primary outcome measure.