Actively Recruiting
Pregnenolone as a Treatment for Cannabis Intoxication
Led by Johns Hopkins University · Updated on 2026-05-01
20
Participants Needed
1
Research Sites
140 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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). By clarifying the ability of pregnenolone to reverse cannabis intoxication symptoms, this study will pave the way for larger clinical studies that provide a foundation for the development of future CB1-receptor NAM medications that could be applied in emergency situations and potentially validate pregnenolone as a treatment for cannabis intoxication.
CONDITIONS
Official Title
Pregnenolone as a Treatment for Cannabis Intoxication
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 18-65
- Good general health based on screening procedures including physical exam, blood testing, and psychiatric evaluation
- Systolic blood pressure below 140 mm Hg, diastolic blood pressure below 90 mm Hg, and heart rate below 110 bpm at screening and baseline for dosing sessions
- Body mass index (BMI) between 18 and 36 kg/m2
- Cannabis use within the past three years but none in the month prior to the first test session
- Negative urine test for illicit substances and negative breath alcohol test at screening and before study sessions
You will not qualify if you...
- Use of psychoactive substances other than nicotine, caffeine, and alcohol in the month prior to study start
- Current use of OTC drugs, supplements, or prescription medications that may affect safety as judged by medical staff
- Use of medications or supplements known to interact with cannabis or pregnenolone
- Clinically significant cardiovascular conditions or history including coronary artery disease, stroke, angina, uncontrolled hypertension, arrhythmias, heart valve placement, or recent TIA
- History of hormone-sensitive conditions such as gynecologic cancers, endometriosis, uterine fibroids, thyroid, pituitary or adrenal syndromes, or polycystic ovarian syndrome
- Epilepsy or history of seizures
- Abnormal liver or kidney function tests beyond specified limits
- Current or past diagnosis of schizophrenia spectrum, other psychotic disorders, or bipolar disorder
- Unstable or compromising medical or psychiatric conditions interfering with safety
- Previous diagnosis and treatment for Cannabis Use Disorder
- Positive urine drug screen for specified substances at screening or before sessions
- Positive breathalyzer test at screening or before sessions
- Pregnancy or nursing
- Women of childbearing potential not using effective contraception methods
- High blood pressure or pulse rates at screening or before dosing
- Recent blood donation within 30 days
- Allergy to eggs or food allergies making brownie ingestion unsafe
- Use of medications or supplements that strongly affect CYP3A4 or CYP2C9 enzymes
AI-Screening
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Trial Site Locations
Total: 1 location
1
Johns Hopkins University School of Medicine, Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States, 21224
Actively Recruiting
Research Team
D
David Wolinsky, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
4
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