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NCT00708994 Clinical Trial

Cannabinoids, Neural Synchrony, and Information Processing

Psychotic Disorders Clinical Trial

— THC-Gamma  

Official title:
Cannabinoids, Psychosis, Neural Synchrony, and Information Processing

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00708994
Other study ID # 0803003638
Secondary ID 5R21DA020750-02
Status Completed
Phase Early Phase 1
First received
Last updated
Start date February 25, 2008
Est. completion date December 3, 2012

Study information
Verified date February 2022
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 42
Est. completion date December 3, 2012
Est. primary completion date December 3, 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Related Conditions & MeSH terms

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

Locations
Country Name City State
United States VA Connecticut Healthcare System West Haven Connecticut

Sponsors (2)
Lead Sponsor Collaborator
Yale University National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary EEG +30
Primary Clinician Administered Dissociative Symptoms Scale, Positive and Negative Symptom Scale, Visual Analog Scale Baseline, +10, +80
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