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

Sponsor

Yale University (Other)

Overall Status

Completed

CT.gov ID

NCT00982982

Collaborator

(none)

Enrollment

Location

Arms

48.4

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Mental Disorders Psychotic Disorders	Drug: THC and Iomazenil Drug: Placebo (control)	Early Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Feb 11, 2009

Actual Primary Completion Date :

Feb 22, 2013

Actual Study Completion Date :

Feb 22, 2013

Arms and Interventions

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

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

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

Outcome Measures

Primary Outcome Measures

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]