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Testing the Interactive Effects of Delta-9-Tetrahydrocannabinol and Pregnenolone: Sub-Study I

NCT02811939 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2022-03-02

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 Dronabinol (THC).

Conditions

  • Healthy

Interventions

DRUG

Active Dronabinol

20 mg capsule of Dronabinol will be administered orally

DRUG

Active Pregnenolone

1.79 mg/kg of Pregnenolone will be administered sublingually (under the tongue)

DRUG

Placebo Dronabinol

Control: Placebo pill (no active cannabinoids) administered orally

DRUG

Placebo Pregnenolone

Control: Placebo given sublingually (under the tongue)

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Deepak Cyril D'Souza, MD · Yale Univerisity, School of Medicine

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
2016-04-07
Primary Completion
2017-06-09
Completion
2017-06-09

Countries

  • United States

Study Locations

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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 NCT02811939 on ClinicalTrials.gov