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New treatment option for Cannabis Intoxication
Official title Pregnenolone as a Treatment for Cannabis Intoxication
ClinicalTrials.gov ID: NCT07216690
What this study is testing
What is Cannabis?
Cannabis is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for cannabis intoxication.
Also referred to as delta-9-tetrahydrocannabinol, THC.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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...
- Current use of any prescription or non-prescription medications, including herbal medicines and supplements, that are known to interact with cannabis...
- Self-report or ECG indicating clinically significant cardiovascular conditions, including coronary artery disease, stroke, angina, uncontrolled...
- History of hormone-sensitive conditions, including but not limited to gynecologic cancers (breast, ovarian, uterine, etc), endometriosis, uterine...
- Epilepsy or a history of seizures
See the full eligibility 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
- 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...
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.