Cannabis, Psychotic Disorders
Conditions
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).
Interventions
DRUGTHC
* 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.
DRUGPlacebo
• Control: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes
Sponsors
National Institute on Drug Abuse (NIDA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EEG | +30 |
| Clinician Administered Dissociative Symptoms Scale, Positive and Negative Symptom Scale, Visual Analog Scale | Baseline, +10, +80 |
Countries
United States
Outcome results
None listed