Testing the Interactive Effects of Delta-9-Tetrahydrocannabinol and Pregnenolone

NCT02576912 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2023-08-07

No results posted yet for this study

Summary

The overall purpose of this study is to examine the effect of pregnenolone (PREG) on the acute psychosis-like and cognitive effects of Delta-9-tetrahydrocannabinol (THC). This will be tested by pretreating healthy individuals with PREG and then assessing their responses to THC.

Conditions

  • Healthy

Interventions

DRUG

Active Delta-9-THC

Active Delta-9-THC (0.036 mg/kg) given intravenously.

DRUG

Active Pregnenolone

A dose given sublingually.

DRUG

Placebo

A placebo dose given sublingually.

DRUG

Placebo

Placebo dose given intravenously.

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Deepak C D'Souza, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2019-06-24
Completion
2019-06-24

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02576912 on ClinicalTrials.gov