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Development of a Pharmacodynamic Biomarker of Opioid Antagonism in Adolescents with Eating Disorders

Award Number: K23MH130728
ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP
PERIOD OF PERFORMANCE START DATE: 05/01/2023
PERIOD OF PERFORMANCE END DATE: 04/30/2027

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Development of a Pharmacodynamic Biomarker of Opioid Antagonism in Adolescents with Eating Disorders - Project Summary The overall goal of this 4-year K23 proposal is to support Dr. Stephani Stancil to become an independent investigator in the field of pharmacodynamic biomarker development to support quantitative early-stage drug development in pediatric neuropsychopharmacology, specifically eating disorder therapeutics. This proposal aligns with NIMH’s prioritization of and the National Advisory Mental Health Council workgroup recommendations for quantitative pharmacologic early-stage trials, particularly in vulnerable populations. Eating disorders (ED), including Bulimia Nervosa, Anorexia Nervosa-Binge/Purge and Binge Eating Disorder, are characterized by binge eating and purge behaviors (e.g., vomiting), typically begin in adolescence, and affect up to 5% of teens. EDs are associated with significant morbidity (e.g., malnutrition, cardiac compromise, development of substance use disorder), have the highest mortality rate of any psychiatric illness and are not responsive to current pharmacotherapy. This career development proposal will leverage Dr. Stancil’s clinical pharmacology expertise in drug exposure inquiry and expand her career focus to clinical neuropsychopharmacology to enable her to define central nervous system drug action in children and adolescents. The comprehensive career development plan (CDP) contains three training objectives: 1) neuroimaging, 2) pediatric randomized clinical trials, and 3) exposure-response modeling, to transition Dr. Stancil into a successful, independent investigator. The CDP’s structured mentoring, didactic training and experiential learning will be applied to a randomized, placebo-controlled crossover trial in adolescents with Binge/Purge ED to accomplish the following aims: Aim 1) Determine the sensitivity of a neuroimaging biomarker to reward system modulation by opioid antagonism, Aim 2) Develop an Exposure-Response Model for naltrexone. Dr. Stancil’s career development and research will take place in a highly favorable and well- suited environment that includes a tertiary academic children’s medical center, children’s research institute, joint department of pediatrics shared by two regional medical schools, an outstanding imaging center and the Frontiers CTSA. After completing this project, Dr, Stancil will have advanced the field of pharmacodynamic biomarker development in pediatric mental health and generated data to support an R01 application to establish the validity of the proposed pharmacodynamic biomarker. She will be well-positioned to become a leader in the field of pharmacodynamic biomarker development and exposure-response linkage to de-risk early-stage drug development and facilitate a precision therapeutics approach to pediatric neuropsychopharmacology.


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: 2025 ( Subtotal = $183,980 )
2025	2025	CHILDRENS MERCY HOSPITAL	2401 GILLHAM RD	KANSAS CITY	MO	64108	JACKSON	USA	Mental Health Research Grants	000	3	4/11/2025	NON-COMPETING CONTINUATION	$183,980
														Subtotal = $183,980

Issue Date FY: 2024 ( Subtotal = $184,623 )
2024	2024	CHILDRENS MERCY HOSPITAL	2401 GILLHAM RD	KANSAS CITY	MO	64108	JACKSON	USA	Mental Health Research Grants	000	2	5/24/2024	NON-COMPETING CONTINUATION	$184,623
														Subtotal = $184,623

Issue Date FY: 2023 ( Subtotal = $187,485 )
2023	2023	CHILDRENS MERCY HOSPITAL	2401 GILLHAM RD	KANSAS CITY	MO	64108	JACKSON	USA	Mental Health Research Grants	000	1	5/1/2023	NEW	$187,485
														Subtotal = $187,485

Grand Total All Awards = $556,088

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Development of a Pharmacodynamic Biomarker of Opioid Antagonism in Adolescents with Eating Disorders

Award Number: K23MH130728

ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP

PERIOD OF PERFORMANCE START DATE: 05/01/2023

PERIOD OF PERFORMANCE END DATE: 04/30/2027

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