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

Early Phase 1

Completed

• Conditions: Schizophrenia; Mental Disorders; Psychotic Disorders
• Interventions: Drug: Placebo (control); Drug: THC and Iomazenil

• Registration Number: NCT00982982
• Lead Sponsor: Yale University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-02-11
• Study First Submitted: 2009-08-18
• Study First Submitted QC: 2009-09-22
• Study First Posted: 2009-09-23
• Primary Completion: 2013-02-22
• Study Completion: 2013-02-22
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-02
• Last Update Posted: 2022-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 17

Inclusion Criteria

• Exposed to cannabis at least once in their lifetime

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Exclusion Criteria

• Cannabis naïve
• History of hearing deficit

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo (control)	Control: small amount of alcohol intravenous (quarter teaspoon), with no THC
THC and Iomazenil	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

Primary Outcome Measures

Name	Time	Method
Clinician Administered Dissociative Symptoms 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
Perceptual Aberration 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
Auditory Verbal Learning Test	On each test day at: baseline, +10min after infusion, +70min, +150min, +240min

Trial Locations

Locations (1)

VA Connecticut Healthcare System; 🇺🇸 West Haven, Connecticut, United States