Cannabinoids, Neural Synchrony, and Information Processing

ID: NCT00708994
Status: Active, not recruiting
Phase: Phase 1
Start Date: April 01, 2008
First Submitted: July 01, 2008
Last Updated: November 28, 2017
Results: N/A
Organization: Yale University
Sponsors & Collaborators: Yale University, National Institute on Drug Abuse (NIDA)
Location: United States
Conditions: Cannabis, Psychotic Disorders
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Study Description

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

Condition or disease Intervention/treatment Phase

Cannabis

Psychotic Disorders

Drug: THC
Other Names
Drug: Placebo
Other Names
Phase 1

Tracking Information

First Submitted DateJuly 01, 2008
Last Update Posted DateNovember 28, 2017
Start DateApril 01, 2008
Anticipated Completion DateDecember 01, 2017
Primary Completion DateDecember 01, 2017
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • EEG [Time Frame: +30]

  • Clinician Administered Dissociative Symptoms Scale, Positive and Negative Symptom Scale, Visual Analog Scale [Time Frame: Baseline, +10, +80]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

Not Available

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleCannabinoids, Neural Synchrony, and Information Processing
Official TitleCannabinoids, 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

Study TypeInterventional
Study PhasePhase 1
Estimated Enrollment
36
Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
Quadruple
Primary Purpose
Basic Science
Conditions
Cannabis
Psychotic Disorders
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
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.

Other Names
Drug: Placebo

• Control: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes

Other Names
Study Groups/Cohorts
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
• Control: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes

Study Arms
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

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.

Arm Intervention/Treatment
Placebo Comparator Placebo
• Control: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes
Drug : Placebo
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

Recruitment Information

Recruitment Status:Active, not recruiting
Enrollment36
Completion DateDecember 01, 2017
Eligibility 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
GenderAll
Age18 Years to 55 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT00708994
Other Study ID Numbers
0803003638
5R21DA020750-02
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyDeepak C. D'Souza, Yale University
Study Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator
Deepak D'Souza, MD
Yale University Medical School