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

Yale University

Status and phase: Completed; Early Phase 1

Conditions: Psychotic Disorders; Mental Disorders; Schizophrenia

Treatments: Drug: Placebo (control); Drug: THC and Iomazenil

Study type: Interventional

Funder types: Other

Identifiers

NCT00982982

0901004662

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Exposed to cannabis at least once in their lifetime

Exclusion criteria

• Cannabis naïve
• History of hearing deficit

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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17 participants in 2 patient groups, including a placebo group

THC and Iomazenil

Active Comparator group

Description:

* 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

Treatment:

Drug: THC and Iomazenil

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo (control)