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

Tracking Information

First Received Date ^ICMJE

July 1, 2008

Last Updated Date

March 11, 2013

Start Date ^ICMJE

April 2008

Estimated Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary 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: +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 ]

Change History

Complete list of historical versions of study NCT00708994 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Cannabinoids, Neural Synchrony, and Information Processing

Official Title ^ICMJE

Cannabinoids, Psychosis, Neural Synchrony, and Information Processing

Brief Summary

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).

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

Cannabis
Psychotic Disorders

Intervention ^ICMJE

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

Study Arm (s)

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

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:

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:

Cannabis naïve
Positive pregnancy screen during screening
Hearing deficits

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Christina Luddy, B.S.

203-932-5711 ext 4549

christina.luddy@yale.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00708994

Other Study ID Numbers ^ICMJE

0803003638, 5R21DA020750-02

Has Data Monitoring Committee

Not Provided

Responsible Party

Deepak C. D'Souza, Yale University

Study Sponsor ^ICMJE

Yale University

Collaborators ^ICMJE

National Institute on Drug Abuse (NIDA)

Investigators ^ICMJE

Principal Investigator:

Deepak D'Souza, MD

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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