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

This study is ongoing, but not recruiting participants.
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: May 19, 2016
Last verified: May 2016

July 1, 2008
May 19, 2016
April 2008
December 2016   (final data collection date for primary outcome measure)
  • 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 ]
  • 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: +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 ]
Complete list of historical versions of study NCT00708994 on ClinicalTrials.gov Archive Site
Not Provided
Lifetime Marijuana Use Scale, THC serum levels, CRMs [ Time Frame: -60, +10, +80, +240 and Life time Marijuana Use Scale only on Day 1 Baseline ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Cannabinoids, Neural Synchrony, and Information Processing
Cannabinoids, Psychosis, Neural Synchrony, and Information Processing
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).
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
  • Cannabis
  • Psychotic Disorders
  • 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.
  • Drug: Placebo
    • Control: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes
  • 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.
    Intervention: Drug: THC
  • Placebo Comparator: Placebo
    • Control: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
36
December 2016
December 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00708994
0803003638, 5R21DA020750-02
Not Provided
Not Provided
Not Provided
Deepak C. D'Souza, Yale University
Yale University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Deepak D'Souza, MD Yale University Medical School
Yale University
May 2016

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