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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Yale University
Sponsor:
Information provided by (Responsible Party):
Deepak C. D'Souza, Yale University
ClinicalTrials.gov Identifier:
NCT00982982
First received: August 18, 2009
Last updated: June 13, 2014
Last verified: June 2014

August 18, 2009
June 13, 2014
February 2009
June 2015   (final data collection date for primary outcome measure)
  • Clinician Administered Dissociative Symptoms Scale [ Time Frame: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min ] [ Designated as safety issue: Yes ]
  • Positive and Negative Symptom Scale [ Time Frame: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min ] [ Designated as safety issue: Yes ]
  • Visual Analog Scale [ Time Frame: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min ] [ Designated as safety issue: Yes ]
  • Auditory Verbal Learning Test [ Time Frame: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min ] [ Designated as safety issue: Yes ]
  • Perceptual Aberration Scale [ Time Frame: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00982982 on ClinicalTrials.gov Archive Site
Not Provided
  • Spectral power of EEG response to auditory steady state entrainment event-related spectral perturbations and change in inter-trial phase coherence dose-dependent alteration in the amplitudes of the ERP components with auditory oddball task performance [ Time Frame: On eac test day at: baseline, -100min pre infusion, -45min pre infusion, +10min after infusion, +25min, +70min, +80min, +150min, +240min and Life time Marijuana Use Scale only on Day 1 Baseline ] [ Designated as safety issue: Yes ]
  • Lifetime Marijuana Use Scale [ Time Frame: Baseline on Test Day 1 ] [ Designated as safety issue: Yes ]
  • THC serum levels [ Time Frame: On each test day at: Baseline, -100min pre infusion, -45min pre infusion, +10min after infusion, +25min, +70min, +80min, +150min, +240min ] [ Designated as safety issue: Yes ]
  • CRM's serum levels [ Time Frame: On each test day at: Baseline, -100min pre infusion, -45min pre infusion, +10min after infusion, +25min, +70min, +80min, +150min, +240min ] [ Designated as safety issue: Yes ]
  • Iomazenil serum levels [ Time Frame: Baseline, -100, -45, +10, +25, +70, +80, +150, +240 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Effects of Delta-9-THC and Iomazenil in Healthy Humans
Gamma-Amino Butyric Acid (GABA) Deficits and Vulnerability to Cannabinoid-Induced Psychosis

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
  • Schizophrenia
  • Mental Disorders
  • Psychotic Disorders
  • 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
  • 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
    Intervention: Drug: THC and Iomazenil
  • Placebo Comparator: Placebo
    Control: small amount of alcohol intravenous (quarter teaspoon), with no THC
    Intervention: Drug: Placebo (control)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
June 2015
June 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Exposed to cannabis at least once in their lifetime

Exclusion Criteria:

  • Cannabis naïve
  • History of hearing deficit
Male
18 Years to 55 Years
Yes
Contact: Prerana Purohit, BA 203-932-5711 ext 4495 prerana.purohit@yale.edu
United States
 
NCT00982982
0901004662, 5R21 DA 020750 -02
Yes
Deepak C. D'Souza, Yale University
Yale University
Not Provided
Principal Investigator: Deepak C D'Souza, M.D Yale University Medical School
Yale University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP