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NCT03655717 · ClinicalTrials.gov registry record · NA
Using Imaging to Assess Effects of THC on Brain Activity
A NA study of Intoxication Alcohol and Intoxication THC, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 316
- Enrollment target
- 1
- Study location
NCT03655717: Completed NA study of Intoxication Alcohol and Intoxication THC, sponsored by Massachusetts General Hospital.
NCT03655717 is a NA study of Intoxication Alcohol and Intoxication THC that has completed, run by Massachusetts General Hospital. The registered enrollment target is 316 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03655717, a NA study of Intoxication Alcohol and Intoxication THC, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 316 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Subjects completed the N-back task 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 change in 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).
Conditions Studied
Interventions
- DRUG Ethanol
- DRUG Dronabinol
- DRUG Placebo dronabinol
- DRUG Placebo ethanol
Study Locations (1)
Massachusetts
- Center for Addiction Medicine, Massachusetts General Hospital, Dept. of Psychiatry - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 316 participants |
| Start Date | 2018-11-05 |
| Est. Completion | 2021-01-21 |
| Phase | NA |
What the finished NCT03655717 record still lists
NCT03655717 is an interventional study that assigns participants to a tested intervention. The registered 316 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (77% lower).
The record links to 3 conditions, with Intoxication Alcohol appearing as the primary indexed condition, and to 4 interventions - of which Ethanol is the first listed.
NCT03655717 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03655717 about?
NCT03655717 is a clinical study titled "Using Imaging to Assess Effects of THC on Brain Activity". 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 ...
What is the current status of trial NCT03655717?
This trial is currently completed. It is a NA study. The enrollment target is 316 participants. The study started on 2018-11-05. Estimated completion is 2021-01-21.
What conditions does trial NCT03655717 study?
This clinical trial studies the following conditions: Intoxication Alcohol, Intoxication THC, Intoxication Combined Alcohol THC.
What interventions are being tested in trial NCT03655717?
The interventions under investigation include: Ethanol (DRUG), Dronabinol (DRUG), Placebo dronabinol (DRUG), Placebo ethanol (DRUG).
Who is sponsoring clinical trial NCT03655717?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03655717 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03655717's enrollment target sits among peer trials
316 321st of 2000 higher than 1,678 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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