Status:
NOT_YET_RECRUITING
Pregnenolone as a Treatment for Cannabis Intoxication
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cannabis Intoxication
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 t...
Detailed Description
This human laboratory study will characterize the ability of pregnenolone to reverse the acute cannabis intoxication using measures of subjective drug effects, cardiovascular responses, and cognitive ...
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.
- Self-report 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 \> 378 U/L (normal range 38-126)
- Total bilirubin \>2.5 mg/dl (normal values=0.3-1.0 mg/dL)
- Glomerular filtration rate (EGFR) \< 45 (normal values \>60)
- 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 indicating the presence of substances including amphetamines, barbiturates, benzodiazepines, cocaine, opioids (including fentanyl), PCP, and THC at screening and prior to study sessions
- Breath 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), vaginal ring, and/or regular use of condoms or diaphragm.
- Breath alcohol screens indicating presence of alcohol at screening and prior to study sessions
- SBP \>/= 140, DBP \>/= 90, or pulse \>/=100 during screening and/or prior to dosing session
- Has donated blood within 30 days of the study
Key Trial Info
Start Date :
January 15 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07216690
Start Date
January 15 2026
End Date
January 1 2029
Last Update
December 5 2025
Active Locations (1)
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1
Johns Hopkins University School of Medicine, Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States, 21224