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A Systematic Medical Approach to Reward Transformation SMART for Brain Health in Opioid Use Disorder

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41MD012318-01
Agency Tracking Number: R41MD012318
Amount: $220,560.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 102
Solicitation Number: MD17-002
Timeline
Solicitation Year: 2017
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-09-21
Award End Date (Contract End Date): 2019-08-31
Small Business Information
3901 CALVERTON BLVD, STE 185
Calverton, MD 20705-3417
United States
DUNS: 620842513
HUBZone Owned: Yes
Woman Owned: No
Socially and Economically Disadvantaged: Yes
Principal Investigator
 MARJORIE GONDRELEWIS
 (202) 806-7793
 mgondre-lewis@howard.edu
Business Contact
 KEVIN MITCHELL
Phone: (443) 280-0332
Email: kmitchell@versais.com
Research Institution
 HOWARD UNIVERSITY
 
525 BRYANT ST, STE 137, NW
WASHINGTON, DC 20059-0005
United States

 Nonprofit college or university
Abstract

Summary
In recent years opioid use disorder OUD and deaths due to opiate overdose e g with heroin fentanyl
oxycodone in suburban and rural non minority groups has created an urgency for approaches to stem this
epidemic but the rise in OUD and opiate overdose deaths has occurred in inner cities at similar rates
Heroin misuse and addiction are persistent problems in African American communities and in inner cities
and a widely understudied trend is that addiction to opioid medication and heroin has become the major
cause of morbidity crime and infectious disease in a huge segment of the African American population
Despite recent efforts to expand addiction research recruitment to include minorities significant race
disparities persist for African Americans and this disparity negatively impacts access to affordable but
sophisticated treatment mechanisms available to other groups OUD disrupts reward processing within the
mesocorticolimbic system a process that is in part rooted in genetics Our preliminary studies suggest
that ancestry specific SNPs may govern addiction behavior in specific groups African Americans express
the dopamine receptor DRD A allele at double the frequency of European Americans Moreover
pharmacogenomics PGx testing in a cohort of heroin addicts at our facility reveal a significant
frequency of the CYP A B allele the variant which confers rapid metabolism of the treatment drug
buprenorphine a mu opioid agonist These ancestry specific findings are further corroborated by GWAS
studies in drug addicted patients where the intronic SNP in the KAT B Lysine acetyl transferase B gene
was specifically identified in African Americans and not in European American addicts Based on this
scientific premise we hypothesize that opioid use in African Americans will be associated with
hypodopaminergic alleles that alter the threshold for activating feelings of reward and pleasure within the
dopaminergic system and that these allelic frequencies will differ significantly from European Americans
We propose to develop a targeted system to study genetic risks for reward deficiency using risk gene panel
to assign a genetic addiction risk score GARS comprehensive surveys to determine quality of life and
exposure to stressors and trauma This system will allow prediction of addiction and relapse potential and
delivery of personalized treatment We further propose to develop a dosing strategy for a Neuroadaptogen
amino acid therapy NAAT that will reduce the incidence of relapse to opioid use This is a Systematic
Medical Approach to Reward Transformation SMART for brain health and opioid use disorders in a
mostly African American population in Phase where we will validate the GARS scoring system against
PGx data and ethnically and culturally sensitive life situations Assess the effectiveness of the reward
system targeted NAAT as an effective treatment to reduce relapse in genetically identified high and low
risk groups and Develop a database the SMART Clinical Genomic Registry to facilitate management
of clinical social and genomic data This approach promotes brain health even in non opioid users Narrative
Opioid Addiction is devastating families across America It is now recognized that effective
treatment requires a comprehensive approach inclusive of medically assisted behavioral and
cognitive therapy We have developed such a system which will allow for individualized treatment
that is culturally and ethnically sensitive to African American lifestyles experiences and genetics
a systematic medical approach to reward transformation SMART that will reduce relapse in
addicted individuals but also will improve brain health in general in patients with other
hypodopaminergic states and reward deficiencies It is highly adaptable to other ethnic or
geographic groups

* Information listed above is at the time of submission. *

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