Cannabinoids, Neural Synchrony, and Information Processing (THC-Gamma)

Yale University

Status and phase: Completed; Early Phase 1

Conditions: Psychotic Disorders; Cannabis

Treatments: Drug: THC; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00708994

0803003638

5R21DA020750-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment: 42 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

42 participants in 2 patient groups, including a placebo group

THC

Active Comparator group

Description:

* 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.

Treatment:

Drug: THC

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo