Pregnenolone as a Treatment for Cannabis Intoxication

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT07216690
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Cannabis Intoxication

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Cannabis — DRUG
    Cannabis brownie, 25mg THC
  • Pregnenolone 250 mg — DRUG
    Pregnenolone, low dose, one 250mg pregnenolone capsule and one 0 mg pregnenolone capsule
  • Pregnenolone 500 mg — DRUG
    Pregnenolone, high dose, two 250 mg pregnenolone capsules
  • Placebo — DRUG
    Placebo capsule, 0mg
  • Placebo brownie — DRUG
    Placebo brownie, 0mg THC

Study Details

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.

Key Dates

Start date
Apr 24, 2026
Status verified
Apr 2026
Primary completion
Jan 1, 2028
Completion
Jan 1, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo Brownie and Capsules
    Placebo brownie, 0mg THC; two 0 mg pregnenolone capsules
  • Placebo Comparator: Cannabis/THC brownie and Placebo Capsules
    25mg Cannabis/THC Brownie; two 0 mg pregnenolone capsules
  • Experimental: Cannabis/THC Brownie and Pregnenolone, low dose
    25mg Cannabis/THC Brownie; one 250 mg pregnenolone capsule and one 0 mg pregnenolone capsule
  • Experimental: Cannabis/THC Brownie and Pregnenolone, high dose
    25mg Cannabis/THC Brownie and two 250 mg pregnenolone capsules

Primary Outcome Measure

Mean Peak Change From Baseline Drug Effect as Assessed by the Drug Effect Questionnaire (DEQ) [ Time Frame: baseline and 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dosing ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins University School of Medicine, Behavioral Pharmacology Research UnitBaltimoreMaryland21224
David Wolinsky, MD
[email protected]
646-572-6959
David Wolinsky, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Johns Hopkins University School of Medicine, Behavioral Pharmacology Research Unit· Baltimore, MD

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