Effects of Delta-9-THC and Iomazenil in Healthy Humans
NCT00982982 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 17
Last updated 2022-12-05
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
- 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
Sponsors & Collaborators
-
Yale University
lead OTHER
Principal Investigators
-
Deepak C D'Souza, M.D · Yale University Medical School
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2009-02-11
- Primary Completion
- 2013-02-22
- Completion
- 2013-02-22
- FDA Drug
- Yes
Countries
- United States
Study Locations
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