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OpenTrials
Completed

NCT Number: NCT00982982

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

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.

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Key information

Conditions

Schizophrenia Chemically-Induced Disorders Marijuana Abuse Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Exposed to cannabis at least once in their lifetime

Exclusion criteria

  • Cannabis naïve
  • History of hearing deficit

Treatment and study plan

THC and Iomazenil

Drug
  • 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)

Drug

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

Primary outcomes

  1. Clinician Administered Dissociative Symptoms Scale

    Time frame: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min

  2. Positive and Negative Symptom Scale

    Time frame: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min

  3. Visual Analog Scale

    Time frame: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min

  4. Auditory Verbal Learning Test

    Time frame: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min

  5. Perceptual Aberration Scale

    Time frame: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Sep 23, 2009
Registry last updated
Dec 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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