Could a natural brain chemical help tame cannabis cravings and lift mood?
NCT ID NCT07685964
First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time
Summary
This trial investigates whether pregnenolone, a natural neurosteroid, can help adults who struggle with both cannabis use disorder and major depression. The study involves a small group of 20 participants aged 18 to 50 who use cannabis frequently and want to cut back. Researchers will measure how the body processes pregnenolone and check if it is safe and tolerable over 12 weeks, while also tracking cannabis use and mood changes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pregnenolone
- What this could lead to
- If it works, this could point toward a new treatment that helps people cut back on cannabis while also easing depression symptoms.
- What could go wrong
- This is an early-phase study with only 20 people, so results may not apply broadly. The drug may not work as hoped or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 50 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UT Southwestern Medical Center
Dallas, Texas, 75390, United States
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University of Texas at Dallas
Richardson, Texas, 75080, United States
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- Can a sleep pill curb cannabis addiction?
- Can pairing ketamine with talk therapy beat depression alone?
- Pharmacies vs. street: does regulated cannabis improve health?