Effects of Delta-9-THC and Iomazenil in Healthy Humans

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00982982
• Other study ID #: 0901004662
• Status: Completed
• Phase: Early Phase 1
• Start date: February 11, 2009
• Est. completion date: February 22, 2013

Study information

• Verified date: December 2022
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: February 22, 2013
• Est. primary completion date: February 22, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Exposed to cannabis at least once in their lifetime

Exclusion Criteria:

• Cannabis naïve
• History of hearing deficit

Related Conditions & MeSH terms

• Disease
• Mental Disorders
• Psychotic Disorders
• Schizophrenia

Intervention

Drug:
• 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 (control)
Control: small amount of alcohol intravenous (quarter teaspoon), with no THC

Locations

Country	Name	City	State
United States	VA Connecticut Healthcare System	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician Administered Dissociative Symptoms Scale		On each test day at: baseline, +10min after infusion, +70min, +150min, +240min
Primary	Positive and Negative Symptom Scale		On each test day at: baseline, +10min after infusion, +70min, +150min, +240min
Primary	Visual Analog Scale		On each test day at: baseline, +10min after infusion, +70min, +150min, +240min
Primary	Auditory Verbal Learning Test		On each test day at: baseline, +10min after infusion, +70min, +150min, +240min
Primary	Perceptual Aberration Scale		On each test day at: baseline, +10min after infusion, +70min, +150min, +240min