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Preclinical Evaluation of Naloxone-Dexmedetomidine Safety and Efficacy for Treating Methamphetamine-Induced Agitation in Polysubstance Intoxication

Award Number: R16DA066477
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2026
PERIOD OF PERFORMANCE END DATE: 05/31/2030

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Preclinical Evaluation of Naloxone-Dexmedetomidine Safety and Efficacy for Treating Methamphetamine-Induced Agitation in Polysubstance Intoxication - Agitation in methamphetamine (METH) intoxicated patients is a major danger for both patients and healthcare providers, and DEA schedule IV benzodiazepine sedatives are currently the standard of care for this indication. Unfortunately, METH is increasingly purposely or inadvertently co-administered with opioids (which is driving METH overdose-induced fatality), and the opioid-benzodiazepine combination may result in respiratory depression, coma, and death, as described in the black box warnings for both drug classes. Dexmedetomidine (DEX) is an FDA approved non-DEA scheduled highly potent α2 agonist sedative which produces minimal respiratory depression regardless of the presence of opioids, is compatible in solution with naloxone (NLX), is bioavailable by many routes of administration (including the intranasal route in which NLX is commonly administered), and produces an arousable sedation which facilitates patient care. The preclinical trial described in this R16 SuRE proposal is designed to test repurposed NLX-DEX for safe and effective attenuation of METH-induced agitation in illicit polysubstance exposure. The proposed project will also provide training and experience in drug development for undergraduate, graduate, and professional students in the Appalachia region, which is disproportionately affected by substance use disorder which commonly involves polysubstance use. Specific Aims include 1) evaluating the potential interaction between METH, fentanyl (FENT), and NLX in enhancing METH-induced agitation in rats; 2) comparing the safety and efficacy of NLX-benzodiazepine and NLX-DEX in attenuating METH-FENT intoxication using clinically relevant measures; 3) testing the safety of NLX-DEX during exposure to METH-FENT adulterated with inexpensive low potency α2 agonist sedative xylazine (XYL); and 4) optimizing the level of METH-induced agitation attenuation with an NLX-DEX adjunctive agent (i.e., to produce deeper sedation when needed with fewer adverse effects than high dose DEX). All aims will be performed in male and female rats to evaluate this novel intervention’s efficacy in the face of sex- dependent differences in METH and opioid toxicity since findings are intended to guide the design of human trials of the proposed intervention. All experiments are designed to maximize undergraduate and professional student participation (with leadership opportunities in the execution of dose optimization experiments) and recruit undiscovered research talent in Appalachia to be mentored by a multidisciplinary research team. Both research and student training infrastructure built during this study will be expanded upon to rapidly characterize emerging clinical polysubstance exposures and facilitate the timely development of repurposed interventions to treat and prevent the toxicity of these complex and dangerous illicit drug exposures.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $147,500 )
2026	2026	MARSHALL UNIVERSITY RESEARCH CORPORATION	1 JOHN MARSHALL DR	HUNTINGTON	WV	25755	CABELL	USA	Drug Use and Addiction Research Programs	000	1	7/29/2026	NEW	$147,500
														Subtotal = $147,500

Grand Total All Awards = $147,500

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Preclinical Evaluation of Naloxone-Dexmedetomidine Safety and Efficacy for Treating Methamphetamine-Induced Agitation in Polysubstance Intoxication

Award Number: R16DA066477

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/01/2026

PERIOD OF PERFORMANCE END DATE: 05/31/2030

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