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

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00982982

Enrollment

Registered

2009-09-23

Start date

2009-02-11

Completion date

2013-02-22

Last updated

2022-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Disorders, Psychotic Disorders, Schizophrenia

Keywords

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

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.

Interventions

DRUGTHC 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.

DRUGPlacebo (control)

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Exposed to cannabis at least once in their lifetime

Exclusion criteria

* Cannabis naïve * History of hearing deficit

Design outcomes

Primary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026