Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 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: September 24, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Schizophrenia
Mental Disorders
Psychotic Disorders
Drug: THC and Iomazenil
Drug: Placebo (control)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Gamma-Amino Butyric Acid (GABA) Deficits and Vulnerability to Cannabinoid-Induced Psychosis

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: February 2009
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00982982

Contacts
Contact: Prerana Purohit, BA 203-932-5711 ext 4495 prerana.purohit@yale.edu

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

No publications provided

Responsible Party: Deepak C. D'Souza, Associate Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT00982982     History of Changes
Other Study ID Numbers: 0901004662, 5R21 DA 020750 -02
Study First Received: August 18, 2009
Last Updated: September 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Yale University:
Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Cannabis

Additional relevant MeSH terms:
Disease
Mental Disorders
Psychotic Disorders
Schizophrenia
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features
Gamma-Aminobutyric Acid
GABA Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014