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

Study Overview
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Brief Summary
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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.

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

Conditions
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Schizophrenia, Mental Disorders, Psychotic Disorders

Intervention / Treatment
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* Drug: THC and Iomazenil
* Drug: Placebo (control)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Exposed to cannabis at least once in their lifetime Exclusion Criteria: Cannabis naïve History of hearing deficit

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: THC and Iomazenil<br>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<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Control: small amount of alcohol intravenous (quarter teaspoon), with no THC | Drug: Placebo (control)<br>* Control: small amount of alcohol intravenous (quarter teaspoon), with no THC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Mental Disorders, Psychotic Disorders, Schizophrenia and Disorders with Psychotic Features, Cannabis