drugset / Trial / NCT03655717
Using Imaging to Assess Effects of THC on Brain Activity
Completed
316 enrolled
Massachusetts General Hospital
National Institute on Drug Abuse (NIDA) · collab
RandomizedCrossoverQuadruple-blindBasic science
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.
Timeline
- Start
- 2018-11-05
- Primary completion
- 2021-01-21
- Completion
- 2021-01-21
Publications
- Berchansky M, Evins AE, Evohr B, Himmelsbach Z, Pachas GN, Karunakaran KD, Laufer Goldshtein B, Ozana N, Gilman JM. Detection of Delta9-Tetrahydrocannabinol Impairment Using Resting-State Functional Near-Infrared Spectroscopy: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jan 2;9(1):e2556647. doi: 10.1001/jamanetworkopen.2025.56647.
- Karunakaran KD, Pascale M, Ozana N, Potter K, Pachas GN, Evins AE, Gilman JM. Intoxication due to Delta9-tetrahydrocannabinol is characterized by disrupted prefrontal cortex activity. Neuropsychopharmacology. 2024 Aug;49(9):1481-1490. doi: 10.1038/s41386-024-01876-5. Epub 2024 May 7.
- Gilman JM, Schmitt WA, Potter K, Kendzior B, Pachas GN, Hickey S, Makary M, Huestis MA, Evins AE. Identification of ∆9-tetrahydrocannabinol (THC) impairment using functional brain imaging. Neuropsychopharmacology. 2022 Mar;47(4):944-952. doi: 10.1038/s41386-021-01259-0. Epub 2022 Jan 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alcohol | Other / unclassified | — | Oral |
| Subject | Dronabinol | Other / unclassified | 10 mg | Oral |
| Subject | Dronabinol | Other / unclassified | 80 mg | Oral |