8 registrations that name pregnenolone as a study arm and are recruiting or about to, as ClinicalTrials.gov listed them on Oct 20, 2026. Read each listing for its full criteria and current status.
Kymata never assesses eligibility. Each listing names its own criteria; only its study team can say whether someone can join. Trial doses are given under the trial's monitoring and are not a schedule for anyone outside it.
Filter 8 registrations
Status
Phase
10US sites across 5 states
1
2 to 4
5 to 19
20 or more
All 8 registrations
RecruitingNCT05781009
Pregnenolone for the Treatment of Alcohol Use Disorder
Phase 2
Yale University
About 150 people
Started Jan 8, 2024
In plain words A Phase 2 study of pregnenolone in people 18 to 70, run by Yale University. It plans to enroll about 150 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 70. Conditions: Alcohol Use Disorder.
Male and females, aged 18-70 years;
Regular weekly use of alcohol at least 3X weekly or more at treatment entry;
Must meet current DSM-5 criteria for moderate to severe Alcohol Use Disorders (AUDs) using SCID-I for DSM-5;
No health conditions that would impact trial participation as verified by screening and physical examination and absence of any of the exclusion criterions outlined below;
2 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Pregnenolone; Placebo
Registered summary
This Phase 2 randomized cotrolled trial (RCT) will assess the safety and efficacy of pregnenolone (PREG; 300 mg/day, b.i.d dosing) vs. placebo (PBO) over a 12 week treatment period, and at 1-month post-treatment follow-up in individuals with Alcohol Use Disorder (AUD).
Where, as registered
1 US site in 1 state.
RecruitingNCT05570812
Neuroactive Steroid to Treat Depressed Mood: A Trial for People With HIV
Phase 2
Massachusetts General Hospital
About 120 people
Started Mar 3, 2023
In plain words A Phase 2 study of pregnenolone in people 18 to 85, run by Massachusetts General Hospital. It plans to enroll about 120 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 85. Conditions: Major Depressive Disorder; Anxiety Depression; HIV.
18-85 years
HIV-1 viral load <200 copies/mL on antiretroviral therapy (ART) at screening visit
Center for Epidemiological Studies - Depression (CES-D) score ≥ 20
The exclusion criteria are on the listing.
What it tests, as registered
Placebo; Pregnenolone
Registered summary
This study will determine the effects of pregnenolone on brain function, inflammation and depressive symptoms in people with HIV who have depression. Participants in this study will receive a pill of either pregnenolone or placebo, and can stay on their current antidepression medications. Brain imaging and behavioral assessments will be performed during the study.
Where, as registered
1 US site in 1 state.
RecruitingNCT06188923
A New Intervention to Improve Function in Veterans With Anxiety and Depression
Phase 2
VA Office of Research and Development
About 84 people
Started Aug 14, 2025
In plain words A Phase 2 study of pregnenolone in people 18 to 65, run by VA Office of Research and Development. It plans to enroll about 84 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 65. Conditions: Anxiety and Depression.
Veterans enrolled for care at the Durham Veterans Affairs Health Care System (VAHCS)
Veterans who score a minimum score of 20 or higher (moderate symptoms) on the PHQ-ADS (Kroenke et al 2017)
Oral pregnenolone could reduce the effectiveness of oral contraceptives, thus women will be required to use a medically and study-approved contraceptive or otherwise not be of child-bearing potential.
No anticipated need to alter psychiatric medications for duration of study involvement
1 more inclusion criterion and the exclusion criteria are on the listing.
What it tests, as registered
Pregnenolone; Placebo
Registered summary
Anxiety and depression symptoms occur at high rates in Veteran populations and can significantly impact function, compromising the ability to work and to successfully form and maintain valued relationships. Several other symptoms commonly occur with anxiety and depression, including poor sleep quality and chronic pain. Since all these symptoms frequently occur together, they may have a common underlying biological basis. A single medication that could effectively treat all these symptoms would be ideal. The full summary is on the listing.
Where, as registered
1 US site in 1 state.
RecruitingNCT06238700
Study on Allopregnanolone and Depression in Women Across the Menopause Transition
No phase
Beth Israel Deaconess Medical Center
About 80 people
Started May 1, 2026
In plain words A study of pregnenolone in female participants 40 to 60, run by Beth Israel Deaconess Medical Center. It plans to enroll about 80 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists female participants 40 to 60. Conditions: Depression.
Healthy women ages 40 to 60 years in the menopause transition
Depressive symptoms
Psychotropic medications are allowed if the dose is stable prior to screening and throughout the study
Able to read Arabic numerals and perform simple arithmetic
1 more inclusion criterion and the exclusion criteria are on the listing.
What it tests, as registered
pregnenolone; placebo
Registered summary
This study aims to identify how enhanced allopregnanolone activity (via pregnenolone) affects behavior and neurobiology that may underlie perimenopausal depression.
Where, as registered
1 US site in 1 state.
RecruitingNCT07216690
Pregnenolone as a Treatment for Cannabis Intoxication
Phase 2
Johns Hopkins University
About 20 people
Started Apr 24, 2026
In plain words A Phase 2 study of pregnenolone in people 18 to 65, run by Johns Hopkins University. It plans to enroll about 20 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 65; healthy volunteers accepted. Conditions: Cannabis Intoxication.
Ages 18-65
Good general health based on screening procedures (e.g. physical exam, blood testing, psychiatric evaluation)
Systolic blood pressure <140 mm Hg, diastolic blood pressure < 90 mm Hg, and heart rate <110 bpm at screening
Body mass index (BMI) in the range of 18 to 36 kg/m2
2 more inclusion criteria and the exclusion criteria are on the listing.
The present study will characterize the ability of pregnenolone to reverse the acute intoxication and associated symptoms of cannabis. Healthy adults with a history of cannabis use will be recruited to participate in a placebo-controlled, within-subject crossover study at Johns Hopkins Behavioral Pharmacology Research Unit (BPRU). The full summary is on the listing.
Where, as registered
1 US site in 1 state.
Not yet recruitingNCT07734701
Pregnenolone Treatment for Alcohol Use Disorder and Major Depressive Disorder
Phase 2
Sherwood Brown, MD, PhD
About 100 people
Starts Oct 2026 (estimated)
In plain words A Phase 2 study of pregnenolone in people 21 to 55, run by Sherwood Brown, MD, PhD. It plans to enroll about 100 people at 2 US sites.
Who it lists and where
Who the trial lists, as registered
Lists people 21 to 55. Conditions: Alcohol Use Disorder (AUD); Major Depressive Disorder (MDD).
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.
1 more inclusion criterion and the exclusion criteria are on the listing.
What it tests, as registered
Pregnenolone; Placebo
Registered summary
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 full summary is on the listing.
Where, as registered
2 US sites in 1 state.
Not yet recruitingNCT07685964
Pregnenolone for Cannabis Use Disorder and Depression
Phase 1 and 2
University of Texas Southwestern Medical Center
About 20 people
Starts Sep 2026 (estimated)
In plain words A Phase 1 and 2 study of pregnenolone in people 18 to 50, run by University of Texas Southwestern Medical Center. It plans to enroll about 20 people at 2 US sites.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 50. Conditions: Cannabis Use Disorder; Major Depressive Disorder (MDD).
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
4 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Pregnenolone
Registered summary
This is UG3 phase of a multi-site, milestone-driven UG3/UH3 research program evaluating pregnenolone for individuals with co-occurring cannabis use disorder (CUD) and major depressive disorder (MDD). Pregnenolone is a neurosteroid that modulates cannabinoid receptor signaling and may reduce cannabis-related effects while also improving mood-related symptoms. The primary objective of the UG3 phase is to establish feasibility and generate preliminary data to support a subsequent UH3 randomized clinical trial. The full summary is on the listing.
Where, as registered
2 US sites in 1 state.
Not yet recruitingNCT05935761
Investigating Novel Interventions for Low Back Pain in US Military Veterans: A Randomized Controlled Adaptive Phase II Trial
Phase 2
VA Office of Research and Development
About 108 people
Starts Dec 1, 2026 (estimated)
In plain words A Phase 2 study of pregnenolone in people 18 to 65, run by VA Office of Research and Development. It plans to enroll about 108 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 65. Conditions: Chronic Low Back Pain.
Veterans with chronic low back pain
Based on medical history and medical records, have low back pain (Thoracic Vertebrae 6 or below) present on most days for the preceding 6 months or longer, and fulfill all disease diagnostic criteria (please see disease diagnostic criteria…
Have a weekly mean of 24-hour average pain score 4 at baseline
Negative pregnancy test if female. Sexually active subjects are required to use a medically acceptable form of birth control if they are of childbearing potential and could become pregnant during the study.
3 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Pregnenolone; DHEA; Placebo
Registered summary
Chronic pain symptoms are very common among U.S. Military Veterans and have a profound negative impact on mental health symptoms and quality of life, in addition to increasing risk for suicidal ideation and suicidal behaviors. There are currently extremely few safe and effective pharmacological treatments for chronic pain disorders, and the clinical need to develop new therapeutics for pain has never been more urgent. Fueled by the worsening opioid crisis and further exacerbated by the COVID-19 pandemic, opioid and other drug overdose deaths have climbed to staggeringly high levels. The full summary is on the listing.