Clinical Trial

Using Imaging to Assess Effects of THC on Brain Activity

Study Description

Using Imaging to Assess Effects of THC on Brain Activity

To assess effects of THC (n=150) and THC + alcohol (n =50) in MJ users on prefrontal brain activity with functional near infrared spectroscopy (fNIRS) during resting state and during memory task performance. To do so, 150 participants will complete fNIRS testing 120 minutes following THC or identical placebo at a clinically determined dose of 20-50mg dronabinol (synthetic THC) and 50 participants will complete fNIRS testing following THC/ethanol, THC/placebo ethanol, placebo THC/ethanol, and placebo THC/placebo ethanol, each at at clinically determined doses designed to produce intoxication. During peak intoxication in participants determined to be intoxicated, (intoxication defined as self reported intoxication >50 on 100 point VAS, by field sobriety testing by a Drug Recognition Expert, and by clinical evaluation, the fNIRS HbO signal will be significantly greater than at baseline and than at a post-peak assessment, and/or resting state connectivity will increase with THC.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Drug - Dronabinol

THC (dronabinol) at physician determined doses of 10-50mg designed to produce intoxication.

Drug - Ethanol

Oral Ethanol, dosed to obtain a breath alcohol concentration (BrAC) of approximately 0.05 BrAC (equal to 1-2 standard drinks).

Drug - Placebo Dronabinol

Identical in appearance to active dronabinol (overencapsulation of both active and placebo dronabinol)

Drug - Placebo Ethanol

Placebo ethanol will consist of diet soda used in the active ethanol condition with 0.25ml ethanol floated on top to provide the odor of ethanol and blind the study drug.

Additional Information

Official Study Title

Using Imaging to Assess Effects of THC on Brain Activity

Clinical Trial ID

NCT03655717

ParticipAid ID

b821Le