CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 316 enrolled
Drug / intervention
Dronabinol +3 moredrug
Likely dose
Dronabinol 80mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03655717
NCT03655717N/ACompleted
CompareCT.gov

Using Imaging to Assess Effects of THC on Brain Activity

Massachusetts General Hospital·interventional·Posted Aug 31, 2018·Updated Jul 28, 2022

In Brief

A clinical study evaluating Dronabinol, Ethanol, and 2 other interventions for Intoxication Alcohol and 2 related conditions. Completed, enrolled 316 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIntoxication Alcohol, Intoxication THC, Intoxication Combined Alcohol THC
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 31, 2018
Enrollment StartNov 5, 2018
Primary CompletionJan 21, 2021
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 7.8 years ago

Interventions

Dronabinoldrug

Dronabinol at physician determined doses of 10-80mg designed to produce intoxication.

Ethanoldrug

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

Placebo dronabinoldrug

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

Placebo ethanoldrug

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.