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OpenTrials
Completed

NCT Number: NCT00708994

Cannabinoids, 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).

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Key information

Conditions

Cannabis Chemically-Induced Disorders Marijuana Abuse Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

THC

Drug
  • 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

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

Primary outcomes

  1. EEG

    Time frame: +30

  2. Clinician Administered Dissociative Symptoms Scale, Positive and Negative Symptom Scale, Visual Analog Scale

    Time frame: Baseline, +10, +80

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Cannabinoids, Psychosis, Neural Synchrony, and Information Processing

Acronym: THC-Gamma

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jul 3, 2008
Registry last updated
Mar 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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