A Phase 2 interventional study of Pregnenolone and Placebo in Alcohol Use Disorder (AUD) and Major Depressive Disorder (MDD), sponsored by Sherwood Brown, MD, PhD. Not yet recruiting at 2 sites in United States. Open to participants aged 21 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Sherwood Brown, MD, PhD · Phase 2, Interventional, and Treatment
Among 1,073 studies in Alcoholism with a site in United States — 187 open to participants now, 228 under way, 15 of them phase 3. Alcoholism · United States.
Among the 1,073 studies in Alcoholism with a site in United States, this one is the 390th largest by planned enrollment of the 989 interventional ones that give a count, is one of 55 that started in 2026, is one of 247 in phase 2, reaches primary completion later than 210 of the 227 other live ones, and was the 1,059th registered.
1,676 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
Browse Alcoholism studies →187 of the 1,073 studies in Alcoholism with a site in United States are open now. Recruiting first, the newest first:
Washington State University · Sites in United States
Ages 18+
University of Pennsylvania · Sites in United States
Ages 21–65
National Institute on Drug Abuse (NIDA) · Sites in United States
Ages 18–120
National Institute on Drug Abuse (NIDA) · Sites in United States
Ages 21–100 · Healthy volunteers
Johns Hopkins University · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 237 Alcoholism studies recruiting now, 84 (35%) set no upper age limit and 131 (55%) stop at 75 or younger; 9 take children under 18; 64 take healthy volunteers.
This study: 21 Years to 55 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,073 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 138 · Phase 2 312 · Phase 3 77 · Phase 4 96
First in 1992; this study’s year is marked. 55 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 100 is above the median of 88 across 1,430 interventional studies indexed under Alcoholism.
Median enrollment 80 across the 989 interventional studies, 109 across the 79 observational. Of the 778 that completed or were terminated, 369 (47%) have results posted.
This tab as a report to print or save as PDF → With an account.
64 of 1,073 have an industry lead sponsor. The 10 most frequent:
Sherwood Brown, MD, PhD is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Sherwood Brown, MD, PhD has 2 studies filed under Alcoholism — fewer than ten, so there is no comparison to draw.
83 of the studies in Alcoholism with a site in United States that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06173973Phase 3University of PennsylvaniaEffects of Ketone Supplementation on Acute Alcohol Withdrawal | 2026-12 |
| NCT05015881Phase 3University of PennsylvaniaRelationship Between Brain and Heart Glucose Metabolism in Alcohol Use Disorder | 2026-12 |
| NCT04616781Phase 3University of PennsylvaniaKetone Ester Intervention in Alcohol Use Disorder | 2026-12 |
| NCT06702007Phase 3University of WashingtonElectronic Harm Reduction Treatment for Alcohol | 2027-01 |
| NCT05613608Phase 3University of Colorado, DenverAlcohol Use Disorder and Cannabidiol | 2027-04 |
Add all 83 to your calendar (.ics) → With an account.
Among the 1,073 studies in Alcoholism with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study will evaluate whether pregnenolone is an effective treatment for adults with Alcohol Use Disorder (AUD) and Major Depressive Disorder (MDD). Participants will be randomly assigned to receive either pregnenolone or placebo for 12 weeks in a double-blind study. Researchers will assess alcohol consumption, alcohol craving, depressive symptoms, and anxiety symptoms throughout treatment. The study will also use magnetic resonance imaging (MRI) to examine how pregnenolone affects brain circuits involved in addiction and mood regulation. The goal is to determine whether pregnenolone can improve both alcohol-related and mood-related outcomes and to identify the neural mechanisms associated with treatment response.
Alcohol Use Disorder (AUD) commonly co-occurs with Major Depressive Disorder (MDD), resulting in substantial morbidity and limited treatment success. Pregnenolone is an endogenous neurosteroid that has demonstrated potential therapeutic effects on alcohol use, craving, mood symptoms, and neural pathways implicated in addiction and depression.
This randomized, double-blind, placebo-controlled trial will enroll approximately 100 adults aged 21 to 55 years with DSM-5 diagnoses of AUD and MDD. Participants will be randomized to receive pregnenolone 500 mg/day (250 mg twice daily) or matched placebo for 12 weeks.
The primary objective is to determine whether pregnenolone reduces alcohol consumption compared with placebo. Secondary clinical objectives include evaluating effects on alcohol craving, depressive symptom severity, and anxiety symptoms. Mechanistic objectives include examining the effects of pregnenolone on resting-state functional connectivity between the amygdala and prefrontal cortex and on brain responses to alcohol-related cues using functional magnetic resonance imaging (fMRI).
Clinical assessments will be conducted throughout the treatment period, and MRI scans will be obtained at baseline and Week 12. Relationships between neuroimaging measures and clinical outcomes will also be evaluated. Findings from this study may support the development of a novel treatment approach for individuals with co-occurring AUD and MDD.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive pregnenolone 500 mg/day administered as 250 mg twice daily for 12 weeks.
Drug: Pregnenolone
Participants will receive matching placebo capsules administered twice daily for 12 weeks.
Drug: Placebo
Pregnenolone 500 mg/day administered as 250 mg twice daily for 12 weeks.
Matching placebo capsules administered twice daily for 12 weeks.
Alcohol Consumption
Change in alcohol consumption from baseline to Week 12. The timeline follow-back (TLFB) is a semi-structured interview method assessing recent drinking in which participants retrospectively estimate daily quantity of alcohol consumption during specified time periods. The TLFB will be used to assess alcohol use including drinks/drinking day and drinks/day (7-day average).
Time frame: Baseline to Week 12
Alcohol Craving
Change in alcohol craving severity from baseline to Week 12. The PACS is a 5-item, self-report measure that includes questions about the frequency, intensity and duration of alcohol craving in the previous week. PACS will be used to measure alcohol craving.
Time frame: Baseline to Week 12
Depressive Symptom Severity
Change in depressive symptom severity from baseline to Week 12. The Quick Inventory of Depressive Symptomatology Clinician version (QIDS-C) is a 16-item observer-rated scale assessing depressive symptom severity. The QIDS-C will be used to measure changes in depressive symptom severity.
Time frame: Baseline to Week 12
Anxiety Symptom Severity
Change in anxiety symptom severity from baseline to Week 12. The Hamilton Anxiety Rating Scale (HAM-A) is a 14-item, observer-rated scale assessing anxiety symptom severity. The HAM-A will be used to measure changes in anxiety symptom severity.
Time frame: Baseline to Week 12
Amygdala-Prefrontal Functional Connectivity
Change in resting-state functional connectivity between the amygdala and prefrontal cortex. Resting-state functional connectivity (rsFC) will be measured. Each participant's average connectivity between prefrontal cortex and amygdala regions of interest (ROIs) will be calculated by averaging the Fisher's Z-transformed pairwise correlation coefficients among the selected ROI pairs.
Time frame: Baseline and Week 12
Plan to share: Undecided
Start is estimated for Oct 2026; primary completion for Mar 2031, 53 months later.
Of 122 non-industry phase 2 interventional studies under Alcoholism, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 59. This study's planned 53 months is above that.
Counting every sponsor, half of 134 studies reached it within 33 months; a quarter within 21 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pregnenolone
Sherwood Brown, MD, PhD