Using Imaging to Assess Effects of THC on Brain Activity

• Status: Completed
• Trial end date: 2021-01-21
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Dronabinol; Ethanol

Criteria

Inclusion Criteria:

• Weekly or greater Marijuana users

• Aged 21-55

• Participants must test positive for cannabis and have no serious unstable medical illness

Exclusion Criteria:

• Any unstable, serious medical illness, eg. unstable angina, or cardiovascular event in the past 6 months eg. myocardial infarction or stroke.

• Diabetes, seizure disorder, cirrhosis, schizophrenia, bipolar disorder, clinically significant cardiac conduction disorder, uncontrolled hypertension, tachycardia, renal failure;

• History of syncope, HIV, Hepatitis C, migraines, head injury with prolonged unconsciousness (> 24 hours);

• Allergy to sesame oil (contained in Marinol pills) or marinol capsules

• Current regular use of benzodiazepines or barbiturates, antihistamines, atropine, scopolamine, other anticholinergic agents;

• Current pregnancy or lactation, or trying to become pregnant (confirmed by urine pregnancy test)

• Currently seeking treatment, in treatment, or in recovery from an alcohol use disorder.

• In the opinion of the investigator, not able to safely participate in this study.