Could a natural brain chemical help tame cannabis cravings and lift mood?

NCT ID NCT07685964

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 50 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • UT Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • University of Texas at Dallas

    Richardson, Texas, 75080, United States

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