Overview

This trial is active, not recruiting.

Conditions cannabis, psychotic disorders
Treatments thc, placebo
Phase phase 1
Sponsor Yale University
Collaborator National Institute on Drug Abuse (NIDA)
Start date April 2008
End date December 2016
Trial size 36 participants
Trial identifier NCT00708994, 0803003638, 5R21DA020750-02

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose basic science
Arm
(Active Comparator)
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.
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 Comparator)
• Control: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes
placebo
• Control: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes

Primary Outcomes

Measure
EEG
time frame: +30
Clinician Administered Dissociative Symptoms Scale, Positive and Negative Symptom Scale, Visual Analog Scale
time frame: Baseline, +10, +80

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

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

Additional Information

Official title Cannabinoids, Psychosis, Neural Synchrony, and Information Processing
Principal investigator Deepak D'Souza, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Yale University.