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

This study is currently recruiting participants.

Verified March 2013 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: March 11, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 18, 2009

Last Updated Date

March 11, 2013

Start Date ^ICMJE

February 2009

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00982982 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Gamma-Amino Butyric Acid (GABA) Deficits and Vulnerability to Cannabinoid-Induced Psychosis

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science

Condition ^ICMJE

Schizophrenia
Mental Disorders
Psychotic Disorders

Intervention ^ICMJE

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

Study Arm (s)

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)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2013

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Exposed to cannabis at least once in their lifetime

Exclusion Criteria:

Cannabis naïve
History of hearing deficit

Gender

Male

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Brynn Huguenel, BA

203-932-5711 ext 4549

brynn.huguenel@yale.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00982982

Other Study ID Numbers ^ICMJE

0901004662, 5R21 DA 020750 -02

Has Data Monitoring Committee

Yes

Responsible Party

Deepak C. D'Souza, Yale University

Study Sponsor ^ICMJE

Yale University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Deepak C D'Souza, M.D

Yale University Medical School

Information Provided By

Yale University

Verification Date

March 2013

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

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