Vaped Marijuana to Attenuate Naloxone-Precipitated Withdrawal

Phase 2 Terminated 2 enrolled New York State Psychiatric Institute

RandomizedSequentialDouble-blindBasic science

Summary

The goal of the proposed, proof-of-concept study is to test the combined effects of vaporized marijuana \[Delta-9-tetrahydracannabinol (THC)\] with NLX as a proof of concept towards the possible development of a combined overdose reversal agent with improved tolerability.

Timeline

Start: 2021-11-01
Primary completion: 2024-10-15
Completion: 2024-10-29

Outcome

Outcome not reported

Stopped (Enrollment): “The U.S. Department of Health and Human Services Office of Human Research Protections issued an FWA restriction on NYSPI research that included a pause of human subjects research as of June 23, 2023. Recruitment for this trial will not reopen.”

Publications

Jones JD, Martinez S, Arout C, Haney M, Castillo F, Manubay J, Perez F, Luba RR, Comer SD. The effects of vaped cannabis on the severity of naloxone-precipitated opioid withdrawal. Exp Clin Psychopharmacol. 2026 Jun;34(3):318-323. doi: 10.1037/pha0000796. Epub 2025 Aug 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cannabis	Traditional medicine (herbal / TCM)	0 mg	Inhaled
Subject	Cannabis	Traditional medicine (herbal / TCM)	12.5 mg	Inhaled
Subject	Cannabis	Traditional medicine (herbal / TCM)	25 mg	Inhaled
Subject	Naloxone	Small molecule	0 mg	Intranasal
Subject	Naloxone	Small molecule	4 mg	Intranasal