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Cannabinoids, Neural Synchrony, and Information Processing (THC-Gamma)

This study is currently recruiting participants.
Verified March 2013 by Yale University
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Deepak C. D'Souza, Yale University
ClinicalTrials.gov Identifier:
NCT00708994
First received: July 1, 2008
Last updated: March 11, 2013
Last verified: March 2013
History of Changes
  Purpose

The study examines the effects of delta-9-tetrahydrocannabinol (Δ9-THC), the principal active ingredient of cannabis, on neural synchrony. Neural synchrony is studied using electroencephalography (EEG).


Condition Intervention Phase
Cannabis
Psychotic Disorders
 Drug: THC
Drug: Placebo
 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: Cannabinoids, Psychosis, Neural Synchrony, and Information Processing

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • EEG [ Time Frame: +30 ] [ Designated as safety issue: Yes ]
  • Clinician Administered Dissociative Symptoms Scale, Positive and Negative Symptom Scale, Visual Analog Scale [ Time Frame: Baseline, +10, +80 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 36
Study Start Date: April 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: THC
  • Very low dose (0.0015 mg/kg = 0.21 mg in a 70kg individual) THC, dissolved in alcohol. Administered intravenously over 10 minutes.
  • Low dose (0.015 mg/kg = 1.05 mg in a 70kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4th of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes.
  • Medium dose (0.03 mg/kg = 2.1 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/2 of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes.
 Drug: THC
  • Very low dose (0.0015 mg/kg = 0.21 mg in a 70kg individual) THC, dissolved in alcohol. Administered intravenously over 10 minutes.
  • Low dose (0.015 mg/kg = 1.05 mg in a 70kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4th of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes.
  • Medium dose (0.03 mg/kg = 2.1 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/2 of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes.
Placebo Comparator: Placebo
• Control: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes
 Drug: Placebo
• Control: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women aged 18 and 55 years (extremes included) on the day of the first dosing.
  • Exposed to cannabis at least once.

Exclusion Criteria:

  1. Cannabis naïve
  2. Positive pregnancy screen during screening
  3. Hearing deficits
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00708994

Contacts
Contact: Christina Luddy, B.S. 203-932-5711 ext 4549 christina.luddy@yale.edu

Locations
United States, Connecticut
VA Connecticut Healthcare System Recruiting
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Deepak D'Souza, MD Yale University Medical School
  More Information

No publications provided

Responsible Party: Deepak C. D'Souza, Associate Professor, Yale University
ClinicalTrials.gov Identifier: NCT00708994     History of Changes
Other Study ID Numbers: 0803003638, 5R21DA020750-02
Study First Received: July 1, 2008
Last Updated: March 11, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Marijuana Abuse
Psychotic Disorders
Mental Disorders
Substance-Related Disorders
Schizophrenia and Disorders with Psychotic Features
Tetrahydrocannabinol
Hallucinogens
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on June 13, 2013