RecruitingPhase 2

Pregnenolone as a Treatment for Cannabis Intoxication

United States20 participantsStarted 2026-04-24

Plain-language summary

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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria * 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 and at baseline for dosing session * Body mass index (BMI) in the range of 18 to 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 substance use and negative breath alcohol test (0% breath alcohol concentration) at screening and before study sessions Exclusion Criteria * Use of psychoactive substances (aside from nicotine, caffeine, and alcohol) in the month prior to study initiation * Current use of over the counter (OTC) drugs, supplements/vitamins, or prescription medications that, in the opinion of the investigator or medical staff, will impact the participant's safety. * Current use of any prescription or non-prescription medications, including herbal medicines and supplements, that are known to interact with cannabis or pregnenolone * Self-report or ECG indicating clinically significant cardiovascular conditions, including coronary artery disease, stroke, angina, uncontrolled hypertension, arrhythmias (e.g. atrial fibrillation), heart valve placement, or TIA in the past year. * History of hormone-sensitive conditions, including but not limited to gynecologic cancers (breast, ovarian, uterine, etc), endometriosis, uterine fib…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean Peak Change From Baseline Drug Effect as Assessed by the Drug Effect Questionnaire (DEQ)

Timeframe: baseline and 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dosing

Mean peak change from baseline psychomotor performance as assessed by the Digit Symbol Substitution Task (DSST)

Timeframe: baseline and 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dosing

Mean peak change from baseline working memory performance as assessed by the Paced Auditory Serial Addition Task (PASAT)

Timeframe: baseline and 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dosing

Mean Peak Levels of Blood Pregnenolone, THC, and THC metabolites (11-OH-THC, and THCCOOH. )

Timeframe: baseline and 1.5, 2, 3, 4, and 6 hours post-dosing

Mean Peak Change from Baseline Psychotomimetic effects as assessed by the Psychotomimetic States Inventory (PSI)

Timeframe: baseline and 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dosing

Mean Peak Change From Baseline Heart Rate

Timeframe: baseline and 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dosing

Trial details

NCT IDNCT07216690

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-01-01

Contact for this trial

David Wolinsky, MD

(646) 572-6959 dwolins2@jhmi.edu

View on ClinicalTrials.gov More Cannabis Intoxication trials