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

Primary Purpose

Schizophrenia, Mental Disorders, Psychotic Disorders

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
THC and Iomazenil
Placebo (control)
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Schizophrenia focused on measuring Schizophrenia, Mental Disorders, Psychotic Disorders, Schizophrenia and Disorders with Psychotic Features, Cannabis

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Exposed to cannabis at least once in their lifetime

Exclusion Criteria:

  • Cannabis naïve
  • History of hearing deficit

Sites / Locations

  • VA Connecticut Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

THC and Iomazenil

Placebo

Arm 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

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

Outcomes

Primary Outcome Measures

Clinician Administered Dissociative Symptoms Scale
Positive and Negative Symptom Scale
Visual Analog Scale
Auditory Verbal Learning Test
Perceptual Aberration Scale

Secondary Outcome Measures

Full Information

First Posted
August 18, 2009
Last Updated
December 2, 2022
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT00982982
Brief Title
Effects of Delta-9-THC and Iomazenil in Healthy Humans
Official Title
Gamma-Amino Butyric Acid (GABA) Deficits and Vulnerability to Cannabinoid-Induced Psychosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 11, 2009 (Actual)
Primary Completion Date
February 22, 2013 (Actual)
Study Completion Date
February 22, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Mental Disorders, Psychotic Disorders
Keywords
Schizophrenia, Mental Disorders, Psychotic Disorders, Schizophrenia and Disorders with Psychotic Features, Cannabis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
THC and Iomazenil
Arm Type
Active Comparator
Arm 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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Control: small amount of alcohol intravenous (quarter teaspoon), with no THC
Intervention Type
Drug
Intervention Name(s)
THC and Iomazenil
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Placebo (control)
Intervention Description
Control: small amount of alcohol intravenous (quarter teaspoon), with no THC
Primary Outcome Measure Information:
Title
Clinician Administered Dissociative Symptoms Scale
Time Frame
On each test day at: baseline, +10min after infusion, +70min, +150min, +240min
Title
Positive and Negative Symptom Scale
Time Frame
On each test day at: baseline, +10min after infusion, +70min, +150min, +240min
Title
Visual Analog Scale
Time Frame
On each test day at: baseline, +10min after infusion, +70min, +150min, +240min
Title
Auditory Verbal Learning Test
Time Frame
On each test day at: baseline, +10min after infusion, +70min, +150min, +240min
Title
Perceptual Aberration Scale
Time Frame
On each test day at: baseline, +10min after infusion, +70min, +150min, +240min

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Exposed to cannabis at least once in their lifetime Exclusion Criteria: Cannabis naïve History of hearing deficit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deepak C D'Souza, M.D
Organizational Affiliation
Yale University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Connecticut Healthcare System
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States

12. IPD Sharing Statement

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

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