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Could a brain hormone curb alcohol cravings and lift depression at the same time?

NCT ID NCT07734701

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 29, 2026 · Last updated Aug 25, 2026 · Updated 3 times

Summary

This trial tests whether pregnenolone, a natural hormone, can help adults with both alcohol use disorder and major depression. Participants take either pregnenolone or a placebo for 12 weeks, while researchers track drinking, cravings, and mood. Brain scans will also look at how the treatment affects circuits linked to addiction and emotion.

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 option for people struggling with both alcohol use disorder and depression.
What could go wrong
This is a mid-stage trial with 100 participants, so results may not apply to everyone. Pregnenolone is a hormone and may cause side effects; its effectiveness for this dual condition is not yet proven.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Mar 2031

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

21 to 55 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: * Age 21 to 55 years. * Meets DSM-5 criteria for Alcohol Use Disorder (AUD). * Meets DSM-5 criteria for Major Depressive Disorder (MDD). * Able to provide informed consent. * Willing and able to comply with study procedures and assessments Exclusion Criteria: * Current diagnosis of bipolar disorder, schizophrenia spectrum disorder, or other psychotic disorder. * Current substance use disorder requiring immediate treatment other than alcohol or nicotine. * Significant unstable medical or neurologic illness that would interfere with participation or study assessments. * Contraindications to magnetic resonance imaging (MRI). * Current pregnancy or breastfeeding. * Current use of medications or treatments that would interfere with study participation or interpretation of results. * Significant suicide risk requiring a higher level of care. * Any condition that, in the investigator's judgment, would make participation unsafe or compromise study integrity.

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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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