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Proof-of-Concept Human Laboratory Testing of Novel Drug Candidates Identified by INIA-NeuroImmune

Award Number: U01AA025476
ORGANIZATION: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Project Summary The development of novel medications with robust effect sizes and good safety and tolerability is an INIA RFA research priority. This translational project will respond to this research challenge by providing proof-of-concept human laboratory testing of the top three neuroimmune drug candidates identified as having therapeutic potential for alcohol use disorder by Dr. Mayfield/Farris/Ponomarev's “drugging the network” computational genomic analyses and by Drs. Bell's, Blednov/Messing's, Crabbe/Ozburn's and Lasek's animal models. Drugs identified for human study will either be FDA-approved for other indications or available for study under an IND and will be selected by Dr. Mason based on scientific prioritization by the INIA-Neuroimmune Executive Committee and safety considerations. Drugs will be tested in a highly standardized, reliable, and valid human laboratory model informing the three stages of the addiction cycle: withdrawal/negative affect, preoccupation/anticipation, and binge/intoxication, with human laboratory results serving as an analogue for drinking outcomes of double-blind, placebo-controlled clinical trials. Subjects for each study will be 50 non- treatment-seeking male and female paid volunteers who meet DSM-5 criteria for alcohol use disorder of = moderate severity (AUD-MS). Studies are randomized, double-blind, and placebo-controlled. The treatment duration is at least 1-week and guided by drug pharmacokinetics. The primary endpoint is craving scores in response to in vivo alcohol cues presented in the laboratory, with confirmatory physiological outcomes, and naturalistic measures of drinking, mood, and craving. Specific Aim 1: To evaluate INIA-Neuroimmune drug candidates in paid non-treatment-seeking volunteers with current AUD-MS using the human lab model informing targets for the 3 stages of the addiction cycle. Specific Aim 2: To identify potential biomarkers of clinical outcomes in peripheral markers of stress and inflammation (e.g., high-sensitivity C-reactive protein, selected chemokines, pro- and antiinflammatory cytokines, and cortisol) in collaboration with Drs. Roberto/Roberts/Bajo. Safety Aim: To evaluate the safety and tolerability of INIA-Neuroimmune drug candidates in subjects with AUD-MS, as assessed by significant changes from baseline in EKG, routine blood and urine biochemistry, vital signs, physical exam, and subjective complaints relative to placebo. Hypothesis: The overall hypothesis under test in that, relative to placebo, novel drug candidates identified by INIA- Neuroimmune will significantly attenuate responsivity to alcohol cues in the human lab model and reduce drinking, craving, and negative affect during treatment and 1-month of post-treatment follow-up. Interpretation of Results: Positive findings will provide clinical validation of neuroimmune targets and mechanisms identified by INIA-Neuroimmune and provide a rational basis for later phase testing of candidate drugs as potential therapeutics for AUD-MS.


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: 2022 ( Subtotal = -$2 )
2022	2021	SCRIPPS RESEARCH INSTITUTE, THE	10550 NORTH TORREY PINES RD	LA JOLLA	CA	92037	SAN DIEGO	USA	Alcohol Research Programs	000	5	3/24/2022	NON-COMPETING CONTINUATION	-$2
														Subtotal = -$2

Issue Date FY: 2021 ( Subtotal = $522,391 )
2021	2021	SCRIPPS RESEARCH INSTITUTE, THE	10550 NORTH TORREY PINES RD	LA JOLLA	CA	92037	SAN DIEGO	USA	Alcohol Research Programs	001	5	5/20/2021	NON-COMPETING CONTINUATION	$0
2021	2021	SCRIPPS RESEARCH INSTITUTE, THE	10550 NORTH TORREY PINES RD	LA JOLLA	CA	92037	SAN DIEGO	USA	Alcohol Research Programs	000	5	1/18/2021	NON-COMPETING CONTINUATION	$522,391
														Subtotal = $522,391

Issue Date FY: 2020 ( Subtotal = $522,391 )
2020	2020	SCRIPPS RESEARCH INSTITUTE, THE	10550 NORTH TORREY PINES RD	LA JOLLA	CA	92037	SAN DIEGO	USA	Alcohol Research Programs	000	4	1/23/2020	NON-COMPETING CONTINUATION	$522,391
2020	2020	SCRIPPS RESEARCH INSTITUTE, THE	10550 NORTH TORREY PINES RD	LA JOLLA	CA	92037	SAN DIEGO	USA	Alcohol Research Programs	001	4	8/19/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $522,391

Issue Date FY: 2019 ( Subtotal = $522,391 )
2019	2019	SCRIPPS RESEARCH INSTITUTE, THE	10550 NORTH TORREY PINES RD	LA JOLLA	CA	92037	SAN DIEGO	USA	Alcohol Research Programs	001	3	6/18/2019	NON-COMPETING CONTINUATION	$0
2019	2019	SCRIPPS RESEARCH INSTITUTE, THE	10550 NORTH TORREY PINES RD	LA JOLLA	CA	92037	SAN DIEGO	USA	Alcohol Research Programs	000	3	1/24/2019	NON-COMPETING CONTINUATION	$522,391
														Subtotal = $522,391

Issue Date FY: 2018 ( Subtotal = $522,391 )
2018	2018	SCRIPPS RESEARCH INSTITUTE, THE	10550 NORTH TORREY PINES RD	LA JOLLA	CA	92037	SAN DIEGO	USA	Alcohol Research Programs	002	2	9/21/2018	NON-COMPETING CONTINUATION	$0
2018	2018	SCRIPPS RESEARCH INSTITUTE, THE	10550 NORTH TORREY PINES RD	LA JOLLA	CA	92037	SAN DIEGO	USA	Alcohol Research Programs	000	2	1/22/2018	NON-COMPETING CONTINUATION	$470,154
2018	2018	SCRIPPS RESEARCH INSTITUTE, THE	10550 NORTH TORREY PINES RD	LA JOLLA	CA	92037	SAN DIEGO	USA	Alcohol Research Programs	001	2	5/23/2018	NON-COMPETING CONTINUATION	$52,237
														Subtotal = $522,391

Issue Date FY: 2017 ( Subtotal = $526,145 )
2017	2017	SCRIPPS RESEARCH INSTITUTE, THE	10550 NORTH TORREY PINES RD	LA JOLLA	CA	92037	SAN DIEGO	USA	Alcohol Research Programs	000	1	2/1/2017	NEW	$526,145
														Subtotal = $526,145

Grand Total All Awards = $2,615,707

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Proof-of-Concept Human Laboratory Testing of Novel Drug Candidates Identified by INIA-NeuroImmune

Award Number: U01AA025476

ORGANIZATION: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

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