Pregnenolone as a Treatment for Cannabis Intoxication
Johns Hopkins University
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 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.
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 performance. Participants (n=16) will complete four double-blind, randomized, outpatient sessions. In each session, participants will self-administer cannabis containing either 0 mg THC (placebo) or 25 mg THC (active) via an oral route of administration. Ninety minutes after cannabis administration, participants will self-administer two oral capsules containing either 0 mg pregnenolone or 250 mg p…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
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…
Interventions
- DrugCannabis
Cannabis brownie, 25mg THC
- DrugPregnenolone 250 mg
Pregnenolone, low dose, one 250mg pregnenolone capsule and one 0 mg pregnenolone capsule
- DrugPregnenolone 500 mg
Pregnenolone, high dose, two 250 mg pregnenolone capsules
- DrugPlacebo
Placebo capsule, 0mg
- DrugPlacebo brownie
Placebo brownie, 0mg THC
Location
- Johns Hopkins University School of Medicine, Behavioral Pharmacology Research UnitBaltimore, Maryland