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
52 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
Researchers are evaluating pregnenolone as a possible treatment to reverse the acute intoxication effects and symptoms caused by cannabis use. This study involves healthy adults who have a history of cannabis use and aims to clarify whether pregnenolone can reduce these intoxication symptoms. The findings could support future development of medications targeting CB1 receptors to treat cannabis intoxication, especially in emergency settings, and potentially validate pregnenolone for this purpose. Participants will take part in four double-blind, randomized outpatient sessions where they will self-administer cannabis brownies containing either 0 mg THC (placebo) or 25 mg THC (active). Ninety minutes after cannabis intake, participants will receive oral capsules containing either 0 mg, 250 mg, or 500 mg of pregnenolone. The study groups include placebo brownies with placebo capsules, active THC brownies with placebo capsules, and active THC brownies with low or high doses of pregnenolone. Sessions are spaced about one week apart. During each session, researchers will assess subjective drug effects, cognitive and psychomotor performance, and physiological responses such as heart rate and blood pressure. Blood samples will measure pregnenolone, THC, and metabolites at multiple time points up to eight hours after dosing. The primary outcomes include changes from baseline in drug effects, performance tasks, psychotomimetic symptoms, and vital signs. This study will help determine pregnenolone's potential for treating cannabis intoxication and inform future drug development.
CONDITIONS
Brief 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 such as physical exam, blood tests, and psychiatric evaluation
- Systolic blood pressure under 140 mm Hg, diastolic blood pressure under 90 mm Hg, and heart rate under 110 bpm at screening and baseline
- Body mass index between 18 and 36 kg/m2
- Cannabis use within the past three years but none in the month before 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, or alcohol in the month before the study
- Current use of medications or supplements that might affect safety or interact with cannabis or pregnenolone
- Clinically significant cardiovascular conditions such as coronary artery disease, stroke, angina, uncontrolled hypertension, arrhythmias, heart valve placement, or recent transient ischemic attack
- History of hormone-sensitive conditions including certain cancers, endometriosis, fibroids, thyroid, pituitary, adrenal syndromes, or polycystic ovarian syndrome
- Epilepsy or history of seizures
- Abnormal liver or kidney function based on laboratory tests
- Current or past diagnosis of schizophrenia spectrum, psychotic disorders, or bipolar disorder
- Other unstable or compromising medical or psychiatric conditions affecting safety
- Previous diagnosis and treatment for Cannabis Use Disorder
- Positive urine drug test for substances like amphetamines, barbiturates, benzodiazepines, cocaine, opioids, PCP, or THC at screening or before sessions
- Positive breathalyzer test for alcohol at screening or before sessions
- Pregnant or nursing women
- Women of childbearing potential not using effective birth control methods
- Blood pressure or pulse above study limits at screening or before dosing
- Blood donation within 30 days before the study
- Allergy to eggs or food allergies making brownie ingestion unsafe
- Use of medications that strongly affect CYP3A4 or CYP2C9 enzymes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Four sessions, approximately 1 week apart
Participants complete four outpatient sessions where they self-administer cannabis or placebo brownies followed by pregnenolone or placebo capsules. Each session includes assessments of drug effects, cognitive performance, and physiological responses.
4 visits (in-person)
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
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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