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Pregnenolone for Cannabis Intoxication

This study is testing if pregnenolone (a natural steroid hormone) can help reverse the effects of cannabis intoxication. You might be able to join if you are between 18 and 65 years old, in good general health, and have used cannabis in the past three years. The study will give participants a cannabis brownie (25mg THC) or a placebo brownie (0mg THC), followed by different doses of pregnenolone (250mg or 500mg) or a placebo. Researchers will measure how pregnenolone affects drug effects, thinking skills, and memory. The goal is to see if pregnenolone could be a new way to treat cannabis intoxication. The current recruitment status is unclear, and the study plans to enroll 20 participants.

Study design
This is a placebo-controlled, double-blind, randomized crossover study involving 16 participants. It compares different doses of pregnenolone and placebo after cannabis use.
What's involved
You will complete four outpatient sessions, typically once per week. Each session involves taking a cannabis or placebo brownie, then pregnenolone or placebo capsules, followed by assessments of drug effects, thinking, and physical responses.
Compensation
Not stated in the trial record.
Follow-up
Your drug effects, psychomotor performance, and working memory will be measured at baseline and then at 1.5, 2, 3, 4, 5, 6, 7, and 8 hours after taking the capsules.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07216690

Pregnenolone as a Treatment for Cannabis Intoxication

Recruiting
PHASE2Ages 18–65InterventionalTreatment
Johns Hopkins University
~20 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:CannabisPregnenolone 250 mgPregnenolone 500 mgPlaceboPlacebo brownie

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean Peak Change From Baseline Drug Effect as Assessed by the Drug Effect Questionnaire (DEQ)
Measured over baseline and 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dosing
+6 more outcomes measured

Conditions

Cannabis Intoxication

Explore related trials

Cannabis intoxication

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • David Wolinsky, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

David Wolinsky, MD
[email protected]
(646) 572-6959
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

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 fibroids, thyroid, pituitary and/or adrenal syndromes, polycystic ovarian syndrome, etc.
Epilepsy or a history of seizures
Any of the following laboratory values during screening or upon admission:
AST \> 165 U/L (normal range 19-55)
ALT \> 216 U/L (normal range 19-72)
Alkaline phosphatase \> 1.5x upper limit of normal (ULN)
Total bilirubin \>1.5 ULN
Glomerular filtration rate (EGFR) \< 60 ml/min/1.73m2
Current or past history of meeting DSM-5 criteria for schizophrenia spectrum or other psychotic disorders, or bipolar I or II disorder
Other unstable and/or compromising medical or psychiatric conditions based on clinical interview and/or MINI results that would interfere with participant safety as determined by study physician, including suicidal ideation and/or attempt, psychosis
Previous diagnosis and treatment for Cannabis Use Disorder
Urine drug screen (e.g. Healgen Scientific 14 Panel Rapid Drug Test) indicating the presence of substances including amphetamines, barbiturates, benzodiazepines, cocaine, opioids (including fentanyl), PCP, and THC at screening and prior to study sessions
Breathalyzer screen indicating presence of alcohol at screening and prior to study sessions
Women who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing
Women who are of childbearing potential and sexually active who are not practicing an effective means of birth control including oral contraceptives, progestin implant, transdermal birth control patch, intrauterine device (IUD) or vaginal ring. Women who report use of condoms or diaphragm must use a "double-barrier" method of contraception (i.e. diaphragm and condoms).
SBP \>/= 140, DBP \>/= 90, or pulse \>/=100 during screening and/or prior to dosing session
Has donated blood within 30 days of the study
Allergy to eggs or other food allergies that would make ingestion of brownie mix unsafe.
Use of concomitant medications, including herbal medicines and botanical supplements, that are strong inhibitors or inducers of CYP3A4 and CYP2C9

What this trial measures

  • Mean Peak Change From Baseline Drug Effect as Assessed by the Drug Effect Questionnaire (DEQ)baseline and 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dosing

    Mean Peak change from baseline rating (0-100) of Drug Effect items related to stimulation (e.g., alertness) and sedation (e.g., sleepy/tired) on the DEQ, a visual analog scale (VAS) self-report questionnaire, with 0 being no effect and 100 being maximum effect.

  • Mean peak change from baseline psychomotor performance as assessed by the Digit Symbol Substitution Task (DSST)baseline and 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dosing

    Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Mean peak change from baseline total correct trials in 90-seconds. Minimum score of 0 but no maximum score (higher scores indicate better performance).

  • Mean peak change from baseline working memory performance as assessed by the Paced Auditory Serial Addition Task (PASAT)baseline and 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dosing

    Computerized version of Paced Auditory Serial Addition Task administered to assess working memory performance. Mean peak change from baseline total correct trials out of 90 recorded is primary outcome (higher scores indicate better performance).

  • Mean Peak Levels of Blood Pregnenolone, THC, and THC metabolites (11-OH-THC, and THCCOOH. )baseline and 1.5, 2, 3, 4, and 6 hours post-dosing

    Mean peak levels of pregnenolone, THC, and the THC metabolites 11-OH-THC, and THCCOOH in the blood of participants.

  • Mean Peak Change from Baseline Psychotomimetic effects as assessed by the Psychotomimetic States Inventory (PSI)baseline and 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dosing

    Mean Peak change from baseline rating of PSI, a 48-item scale designed to measure psychotomimetic effects resulting from psychoactive substance use. Participants rate each item on a four-point visual analog scale, 0 (not at all), 1 (slightly), 2 (moderately), or 3 (strongly). Higher score worse effects.

  • Mean Peak Change From Baseline Heart Ratebaseline and 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dosing

    Mean Peak change from baseline heart rate (as measured by beats per minute)

  • Mean Peak Change From Baseline Blood Pressure (mmHg)baseline and 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dosing

    Mean Peak change from baseline blood pressure (systolic and diastolic)