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NOP Receptor Antagonist for OUD Pharmacotherapy

Award Number: UG3DA052282
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2020
PERIOD OF PERFORMANCE END DATE: 08/31/2025

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NOP Receptor Antagonist for OUD Pharmacotherapy - PROJECT SUMMARY The opioid crisis has spawned a myriad of health consequences, including increased incidence of opioid use disorder (OUD), a condition manifested by escalating physical and psychological impairments. Medication- assisted treatment (MAT) aids in reducing mortality, opioid withdrawal, intake and opioid-seeking behaviors, thus substantially improving the odds of successful recovery from OUD, particularly when coupled with psychosocial interventions. Current opioid-based MAT (i.e., buprenorphine) is a leading adjunct in the proper management of OUD patients, however there is a need to increase the armamentarium of therapeutics for OUD. The “non- classical” nociceptin receptor (NOPr) binds the endogenous neuropeptide nociceptin/orphanin FQ (N/OFQ), named for its efficacy to evoke nociception. Robust evidence supports the role of the N/OFQ-NOPr axis in the rewarding effects of alcohol and the therapeutic potential of NOPr ligands in alcohol use disorder. While less is established regarding this system in OUD, published literature implicates NOPr function in the regulation of the rewarding and motivational effects of opioids. Building on the premise that brain N/OFQ-NOPr axis is involved in OUD-related behaviors, we have partnered with BlackThorn Therapeutics to assess their novel and selective NOPr antagonist BTRX-246040 as a potential OUD therapeutic. In this UG3, we will assess BTRX-246040 to block oxycodone intake without abuse liability and to suppress oxycodone withdrawal and relapse-like behaviors in male and female rats. We will also determine drug metabolism and pharmacokinetics interactions (DMPK) between oxycodone and BTRX-246040 and brain penetrability in male and female rats. With achievement of the UG3 milestones, we will conduct a Phase 1 clinical trial in non-treatment seeking OUD participants in the UH3. Relative to placebo, we will ascertain the safety and tolerability of BTRX-246040 following oral oxycodone, the DMPK profile of oral oxycodone following BTRX-246040, and efficacy to suppress opioid craving and drug-liking in OUD participants. The second goal of the UH3 phase is to develop the preclinical data to support the prospect that BTRX-246040 may serve as an adjuvant to buprenorphine MAT. These investigations with the NOPr antagonist BTRX-246040 in the UG3/UH3 will advance the prospects to validate a novel medication for OUD.


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 = -$206,131 )
2026	2020	UNIVERSITY OF TEXAS MEDICAL BRANCH AT GALVESTON	301 UNIVERSITY BLVD	GALVESTON	TX	77555	GALVESTON	USA	Drug Use and Addiction Research Programs	000	1	10/1/2025	NEW	-$206,131
														Subtotal = -$206,131

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2020	UNIVERSITY OF TEXAS MEDICAL BRANCH AT GALVESTON	301 UNIVERSITY BLVD	GALVESTON	TX	77555	GALVESTON	USA	Drug Use and Addiction Research Programs	000	1	8/26/2024	NEW	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2020	UNIVERSITY OF TEXAS MEDICAL BRANCH AT GALVESTON	301 UNIVERSITY BLVD	GALVESTON	TX	77555	GALVESTON	USA	Drug Use and Addiction Research Programs	000	1	6/13/2023	NEW	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2020	UNIVERSITY OF TEXAS MEDICAL BRANCH AT GALVESTON	301 UNIVERSITY BLVD	GALVESTON	TX	77555	GALVESTON	USA	Drug Use and Addiction Research Programs	000	1	8/26/2022	NEW	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2020	UNIVERSITY OF TEXAS MEDICAL BRANCH AT GALVESTON	301 UNIVERSITY BLVD	GALVESTON	TX	77555	GALVESTON	USA	Drug Use and Addiction Research Programs	000	1	9/21/2021	NEW	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $2,793,808 )
2020	2020	UNIVERSITY OF TEXAS MEDICAL BRANCH AT GALVESTON	301 UNIVERSITY BLVD	GALVESTON	TX	77555	GALVESTON	USA	Drug Use and Addiction Research Programs	000	1	8/20/2020	NEW	$2,793,808
														Subtotal = $2,793,808

Grand Total All Awards = $2,587,677

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NOP Receptor Antagonist for OUD Pharmacotherapy

Award Number: UG3DA052282

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/01/2020

PERIOD OF PERFORMANCE END DATE: 08/31/2025

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