Using Imaging to Assess Effects of THC on Brain Activity

Time frame

The first resting-state scan session was run before dosing (t ≈ -45min). Drug was administered (t = 0min). The second resting-state scan session was run at the time of expected peak high (t ≈ 90min). Each scan session was six minutes in duration.

Measure

MEAN · Δ mol/L

Reporting status

POSTED

Subjects completed resting-state fNIRS scans before and after receiving a combination of active dronabinol or placebo dronabinol and active ethanol or placebo ethanol. During the task, the fNIRS device was used to capture concentration of oxygenated hemoglobin to assess prefrontal brain activity. Outcomes reflect average change from baseline in HbO concentration over pre-dose scan and average change from baseline in HbO concentration over post-dose scan (expected peak intoxication).

Population: Note: The Participant Flow lists Phase 2A by randomization sequence (recommended for crossover studies). Phase 2A: Includes participants that completed scans after receiving dronabinol (119 subjects) and after placebo (115 subjects) Phase 2B: Incudes participants that completed scans after receiving dronabinol + ethanol (30 subjects), dronabinol + placebo ethanol (31 subjects), placebo dronabinol + ethanol (28 subjects) and placebo dronabinol + placebo ethanol (34 subjects)

A screening visit took place before randomization. After randomization, phase 2A completed two visits and phase 2B completed four visits. Washout achieved with at least one week between visits. Participant dropout affected by the COVID-19 pandemic. Due to character limit, sequences coded as follows: A: Placebo Dronabinol B: Dronabinol C: Placebo Dronabinol \& Placebo Ethanol D: Dronabinol \& Placebo Ethanol E: Placebo Dronabinol \& Ethanol F: Dronabinol \& Ethanol