Overview

This trial is active, not recruiting.

Conditions schizophrenia, mental disorders, psychotic disorders
Treatments thc and iomazenil, placebo (control)
Phase phase 1
Sponsor Yale University
Start date February 2009
End date June 2017
Trial size 60 participants
Trial identifier NCT00982982, 0901004662

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose basic science
Arm
(Active Comparator)
Iomazenil: 3.7 μg/kg intravenously over 10 minutes Delta-9-THC (0.015 mg/kg = 1.05 mg in a 70kg individual), dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4th of a marijuana cigarette, or "joint". It is administered intravenously for 10 minutes
thc and iomazenil
Iomazenil: 3.7 μg/kg intravenously over 10 minutes Delta-9-THC (0.015 mg/kg = 1.05 mg in a 70kg individual), dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4th of a marijuana cigarette, or "joint". It is administered intravenously for 10 minutes.
(Placebo Comparator)
Control: small amount of alcohol intravenous (quarter teaspoon), with no THC
placebo (control)
Control: small amount of alcohol intravenous (quarter teaspoon), with no THC

Primary Outcomes

Measure
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

Eligibility Criteria

Male participants from 18 years up to 55 years old.

Inclusion Criteria: - Exposed to cannabis at least once in their lifetime Exclusion Criteria: - Cannabis naïve - History of hearing deficit

Additional Information

Official title Gamma-Amino Butyric Acid (GABA) Deficits and Vulnerability to Cannabinoid-Induced Psychosis
Principal investigator Deepak C D'Souza, M.D
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Yale University.