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Next generation PET neuroimaging for safe, accessible measurement of opioid addiction neurobiology

Award Number: R21DA064871
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/15/2026
PERIOD OF PERFORMANCE END DATE: 04/30/2028

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Next generation PET neuroimaging for safe, accessible measurement of opioid addiction neurobiology - Project Summary/Abstract The “Opioid Crisis Response Act of 2018” is a key legislative effort to address the opioid epidemic in United States, recognizing opioid overdoses as one of the nation’s most pressing public health threats. Opioid related deaths have surged since 1999, with over 82,000 deaths in 2022 alone, driven primarily by synthetic opioids like fentanyl. To combat this crisis, there is an urgent need for new translational tools and strategies to better understand the neurobiology of opioid addiction. The mu opioid receptor (MOR) plays a critical role in regulating the respiratory system and neuropsychiatric functions, directly impacting the key concerns of the opioid epidemic – respiratory failure and addiction. Despite its importance in various diseases, the full scope of its role of MOR and its ligands in complex addiction mechanism in human brains remains unclear. To address this, we are developing a new translational tool to study the molecular and cellular mechanisms of receptor dysregulation that contribute to substance abuse and mental health disorders. Non-invasive, quantitative positron emission tomography (PET) imaging of MOR in the human brain will provide crucial perspective into how MOR density and occupancy are linked to its dysregulation. While a handful of conventional MOR-PET probes exist and offer valuable insights through preclinical and clinical imaging studies, they are either too potent or not sensitive enough for studying neurobiology of MOR in the living brain. This proposal focuses on the final preclinical evaluation of a safe, widely accessible PET neuroimaging probe18F-fluorocarfentanil (18F-FCFN). Our team recently developed four derivatives of 18F-FCFN and validated their in vivo suitability as PET neuroimaging probes in rats through proof-of-concept studies. Based on our prior findings, published in 2025, two 18F-FCFN candidates emerged with promising features – high brain uptake, favorable selectivity and specific binding to MOR. We now propose completing final evaluations in higher species to select the best 18F-FCFN candidates for clinical translation. In AIM 1, we will assess the in vivo pharmacokinetics, selectivity, and binding potential (BPND) of these two 18F-FCFN candidates in non-human primates (NHPs) and select the top candidate for further evaluations. In AIM 2, we will determine the whole-body biodistribution and radiation dosimetry of the selected 18F-FCFN candidate in NHPs, along with conducting acute toxicology studies to assess its safety for human use. This work is critical for selecting and advancing the top 18F-FCFN candidate to first-in-human trials.


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 = $451,670 )
2026	2026	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Drug Use and Addiction Research Programs	000	1	5/5/2026	NEW	$451,670
														Subtotal = $451,670

Grand Total All Awards = $451,670

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Next generation PET neuroimaging for safe, accessible measurement of opioid addiction neurobiology

Award Number: R21DA064871

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 05/15/2026

PERIOD OF PERFORMANCE END DATE: 04/30/2028

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