THC and Ketamine Effects in Humans: Relation to Neural Oscillations and Psychosis

NCT04199468 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-03-25

No results posted yet for this study

Summary

The aim of the research protocol is to evaluate cannabinoid-glutamate interactions in humans. As part of this aim the investigators will assess the safety and tolerability of the combination of NMDA antagonist, ketamine, and the cannabinoid, delta-9-tetrahydrocannabinol (THC), in healthy adult subjects, and characterize the interactive effects of ketamine and THC on various electrophysiological (EEG), cognitive, and behavioral outcomes.

Conditions

  • Cannabis
  • Ketamine

Interventions

DRUG

Active Delta-9-THC

Active Delta-9-THC (0.015 mg/kg) given intravenously (IV)

DRUG

Placebo Delta-9-THC

A placebo dose given intravenously (IV)

DRUG

Active Ketamine

Active Ketamine (0.2 mg/kg) given intravenously (IV)

DRUG

Placebo Ketamine

A placebo dose given intravenously (IV)

Sponsors & Collaborators

  • Brain & Behavior Research Foundation

    collaborator OTHER
  • Yale University

    lead OTHER

Principal Investigators

  • Rajiv Radhakrishnan, M.D. · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2019-09-24
Primary Completion
2022-06-21
Completion
2022-06-21
FDA Drug
Yes

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 NCT04199468 on ClinicalTrials.gov