NCT00982982

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.
DRUG	Placebo (control)	Control: small amount of alcohol intravenous (quarter teaspoon), with no THC

Timeline

• Start date: 2009-02-11
• Primary completion: 2013-02-22
• Completion: 2013-02-22
• First posted: 2009-09-23
• Last updated: 2022-12-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study