Clinical Trial: Effects of Delta-9-THC and Iomazenil in Healthy Humans

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Gamma-Amino Butyric Acid (GABA) Deficits and Vulnerability to Cannabinoid-Induced Psychosis

Brief Summary: The study aims to examine the combined effects of delta-9-tetrahydrocannabinol (∆-9-THC or THC) and iomazenil on thinking, perception, mood, memory, attention, and electrical activity of the brain (EEG). THC is the active ingredient of marijuana, cannabis, "ganja", or "pot". Iomazenil is a drug that works opposite to drugs like valium. The purpose of this study is to determine whether the administration of iomazenil will alter the effects of THC.

Detailed Summary:
Sponsor: Yale University

Current Primary Outcome:

  • Clinician Administered Dissociative Symptoms Scale [ Time Frame: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min ]
  • Positive and Negative Symptom Scale [ Time Frame: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min ]
  • Visual Analog Scale [ Time Frame: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min ]
  • Auditory Verbal Learning Test [ Time Frame: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min ]
  • Perceptual Aberration Scale [ Time Frame: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

  • Spectral power of EEG response to auditory steady state entrainment event-related spectral perturbations and change in inter-trial phase coherence dose-dependent alteration in the amplitudes of the ERP components with auditory oddball task performance [ Time Frame: On eac test day at: baseline, -100min pre infusion, -45min pre infusion, +10min after infusion, +25min, +70min, +80min, +150min, +240min and Life time Marijuana Use Scale only on Day 1 Baseline ]
  • Lifetime Marijuana Use Scale [ Time Frame: Baseline on Test Day 1 ]
  • THC serum levels [ Time Frame: On each test day at: Baseline, -100min pre infusion, -45min pre infusion, +10min after infusion, +25min, +70min, +80min, +150min, +240min ]
  • CRM's serum levels [ Time Frame: On each test day at: Baseline, -100min pre infusion, -45min pre infusion, +10min after infusion, +25min, +70min, +80min, +150min, +240min ]
  • Iomazenil serum levels [ Time Frame: Baseline, -100, -45, +10, +25, +70, +80, +150, +240 ]


Information By: Yale University

Dates:
Date Received: August 18, 2009
Date Started: February 2009
Date Completion: June 2017
Last Updated: February 2, 2017
Last Verified: February 2017