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

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ClinicalTrials.gov Identifier: NCT00982982
Recruitment Status : Active, not recruiting
First Posted : September 23, 2009
Last Update Posted : December 2, 2017
Sponsor:
Information provided by (Responsible Party):
Deepak C. D'Souza, Yale University

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) Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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
Study Start Date : February 2009
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Clinician Administered Dissociative Symptoms Scale [ Time Frame: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min ]
  2. Positive and Negative Symptom Scale [ Time Frame: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min ]
  3. Visual Analog Scale [ Time Frame: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min ]
  4. Auditory Verbal Learning Test [ Time Frame: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min ]
  5. Perceptual Aberration Scale [ Time Frame: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Exposed to cannabis at least once in their lifetime

Exclusion Criteria:

  • Cannabis naïve
  • History of hearing deficit

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00982982


Locations
United States, Connecticut
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Deepak C D'Souza, M.D Yale University Medical School

Responsible Party: Deepak C. D'Souza, Associate Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT00982982     History of Changes
Other Study ID Numbers: 0901004662
First Posted: September 23, 2009    Key Record Dates
Last Update Posted: December 2, 2017
Last Verified: November 2017

Keywords provided by Deepak C. D'Souza, Yale University:
Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Cannabis

Additional relevant MeSH terms:
Disease
Schizophrenia
Mental Disorders
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Ethanol
Dronabinol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Hallucinogens
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists