Using Imaging to Assess Effects of THC on Brain Activity

Summary

This study will assess effects of tetrahydrocannabinol (THC) and THC + alcohol in marijuana users on prefrontal brain activity, using functional near-infrared spectroscopy (fNIRS) during resting state and during memory task performance. Participants will complete fNIRS testing 120 minutes following THC or identical placebo (Phase 2A), or THC/ethanol, THC/placebo ethanol, placebo THC/ethanol, and placebo THC/placebo ethanol (Phase 2B), and oxygenated hemoglobin (HbO) concentration will be measured.

Conditions

• Intoxication Alcohol
• Intoxication THC
• Intoxication Combined Alcohol THC

Interventions

DRUG

Dronabinol

Dronabinol at physician determined doses of 10-80mg 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.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• A. Eden Evins, MD, MPH · Massachusetts General Hospital

• Jodi M Gilman, PhD · Massachusetts General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-11-05

Primary Completion

2021-01-21

Completion

2021-01-21

Countries

• United States

Study Locations