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Pregnenolone as a Treatment for Cannabis Intoxication

NCT07216690 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-01

No results posted yet for this study

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.

Conditions

  • Cannabis Intoxication

Interventions

DRUG

Cannabis

Cannabis brownie, 25mg THC

DRUG

Pregnenolone 250 mg

Pregnenolone, low dose, one 250mg pregnenolone capsule and one 0 mg pregnenolone capsule

DRUG

Pregnenolone 500 mg

Pregnenolone, high dose, two 250 mg pregnenolone capsules

DRUG

Placebo

Placebo capsule, 0mg

DRUG

Placebo brownie

Placebo brownie, 0mg THC

Sponsors & Collaborators

Principal Investigators

  • David Wolinsky, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-24
Primary Completion
2028-01-01
Completion
2029-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07216690 on ClinicalTrials.gov