Natural hormone may counteract cannabis high
NCT ID NCT07216690
First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 1 time
Summary
This study tests whether a natural hormone called pregnenolone can reverse the effects of cannabis intoxication. Researchers at Johns Hopkins will give 20 healthy adults who have used cannabis before either pregnenolone or a placebo, then measure changes in drug effects, thinking skills, and vital signs. The goal is to see if pregnenolone could be used in emergencies to treat cannabis overdose or intoxication.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Apr 2026
- Expected to finish
-
Jan 2029
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Cannabis intoxication are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Johns Hopkins University School of Medicine, Behavioral Pharmacology Research Unit
RECRUITINGBaltimore, Maryland, 21224, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- CBD may help heavy cannabis users use less THC
- Teen brain scans may predict cannabis treatment success
- Cannabis brownies and booze: study reveals how they mess with your driving
- Cannabis study to reveal if indica vs. sativa really matters
- Spit test could replace urine checks for cannabis in remote trials
- New study tests how pot and booze mix to impair drivers