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Cannabinoids, Neural Synchrony, and Information Processing

Early Phase 1
Completed
Conditions
Psychotic Disorders
Cannabis
Interventions
Drug: Placebo
Registration Number
NCT00708994
Lead Sponsor
Yale University
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 available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
42
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
PlaceboPlacebo• Control: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes
THCTHC* 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.
Primary Outcome Measures
NameTimeMethod
EEG+30
Clinician Administered Dissociative Symptoms Scale, Positive and Negative Symptom Scale, Visual Analog ScaleBaseline, +10, +80
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

VA Connecticut Healthcare System

🇺🇸

West Haven, Connecticut, United States

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