Pregnenolone as a Treatment for Cannabis Intoxication
ConditionCannabis Intoxication
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Cannabis
- Pregnenolone 250 mg
- Pregnenolone 500 mg
- Placebo
- Placebo brownie
Treatment groups
20 Participants
are divided into 4 treatment groupsSponsors and collaborators
Johns Hopkins University
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov