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

NCT00982982 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: 0901004662
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Mental Disorders; Psychotic Disorders

Keywords

Schizophrenia; Mental Disorders; Psychotic Disorders; Schizophrenia and Disorders with Psychotic Features; Cannabis

Outcome Measures

Primary Outcomes (5)

• Clinician Administered Dissociative Symptoms Scale

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

• Positive and Negative Symptom Scale

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

• Visual Analog Scale

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

• Auditory Verbal Learning Test

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

• Perceptual Aberration Scale

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

Study Arms (2)

THC and Iomazenil

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

Drug: THC and Iomazenil

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo (control)

Interventions

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.

THC and Iomazenil

Placebo (control) DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Exposed to cannabis at least once in their lifetime

You may not qualify if:

• Cannabis naïve
• History of hearing deficit

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Schizophrenia; Mental Disorders; Psychotic Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Marijuana Abuse

Interventions

Dronabinol; iomazenil

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Deepak C D'Souza, M.D

  Yale University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: August 18, 2009
• First Posted: September 23, 2009
• Study Start: February 11, 2009
• Primary Completion: February 22, 2013
• Study Completion: February 22, 2013
• Last Updated: December 5, 2022

Record last verified: 2022-12

Locations

US (1)