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

December 2, 2022 updated by: Deepak C. D'Souza, Yale University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • West Haven, Connecticut, United States, 06516
        • VA Connecticut Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Exposed to cannabis at least once in their lifetime

Exclusion Criteria:

  • Cannabis naïve
  • History of hearing deficit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
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 Comparator: Placebo
Control: small amount of alcohol intravenous (quarter teaspoon), with no THC
Drug: Placebo (control)
Control: small amount of alcohol intravenous (quarter teaspoon), with no THC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinician Administered Dissociative Symptoms Scale
Time Frame: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min
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
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
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
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
On each test day at: baseline, +10min after infusion, +70min, +150min, +240min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Deepak C D'Souza, M.D, Yale University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2009

Primary Completion (Actual)

February 22, 2013

Study Completion (Actual)

February 22, 2013

Study Registration Dates

First Submitted

August 18, 2009

First Submitted That Met QC Criteria

September 22, 2009

First Posted (Estimate)

September 23, 2009

Study Record Updates

Last Update Posted (Actual)

December 5, 2022

Last Update Submitted That Met QC Criteria

December 2, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0901004662

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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