Funded Projects

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Project #	Project Title	Research Focus Area	Research Program	Administering IC Sort descending	Institution(s)	Investigator(s)	Location(s)	Year Awarded
3UG3DA047711-02S1 Show Summary	PHASE 1A/1B CLINICAL TRIALS OF MULTIVALENT OPIOID VACCINE COMPONENTS	Novel Therapeutic Options for Opioid Use Disorder and Overdose	Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose	NIDA	NEW YORK STATE PSYCHIATRIC INSTITUTE	COMER, SANDRA D; PRAVETONI, MARCO	New York, NY	2019
NOFO Title: Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional) NOFO Number: RFA-DA-19-002 Summary: Opioid use disorder (OUD) is a serious public health problem that is associated with high rates of morbidity and mortality. The proposed Phase 1a/1b studies are designed to evaluate a novel treatment strategy for OUD. Specifically, the safety, immunogenicity and preliminary efficacy of a vaccine (OXY-KLH) targeted against oxycodone (Study 1) and a vaccine (M-KLH) targeted against heroin/morphine (Study 2) will be evaluated in participants diagnosed with OUD.
1UG3DA050174-01 Show Summary	Prevention of OUD: The HOME (Housing, Opportunities, Motivation and Engagement) Randomized Trial	New Strategies to Prevent and Treat Opioid Addiction	Preventing Opioid Use Disorder	NIDA	Ohio State University	SLESNICK, NATASHA (contact); KELLEHER, KELLY J	Columbus, OH	2019
NOFO Title: HEAL Initiative: Preventing Opioid Use Disorder in Older Adolescents and Young Adults (ages 16–30) (UG3/UH3 Clinical Trial Required NOFO Number: RFA-DA-19-035 Summary: Evidence suggests that homeless youth have the highest rates of opioid use among youth subgroups in the country (Brands et al., 2005). Resolution of youth homelessness through housing and prevention services, often referred to as “Housing First”, has great potential to reduce the likelihood for the development of an opioid use disorder as well as other problem behaviors associated with living on the streets. However, only 20 percent to 30 percent of homeless youth samples report ever having stayed at a crisis shelter, 9 percent report having ever accessed mental health services, and 15 percent report ever having received treatment for substance use disorder (Ray, 2006), indicating a need to reach and engage youth in services that are feasible and acceptable. The results of this study will provide essential information for researchers and providers on the efficacy of housing plus opioid and related risk prevention services in a randomized controlled trial on opioid use, how moderators affect the response, and mechanisms underlying change.
1R34DA050272-01 Show Summary	1/2 Optimizing access, engagement and assessment to elucidate prenatal influences on neurodevelopment: The Brains Begin Before Birth (B4) Midwest Consortium	Enhanced Outcomes for Infants and Children Exposed to Opioids	HEALthy Brain and Child Development Study (HBCD)	NIDA	WASHINGTON UNIVERSITY	ROGERS, CYNTHIA ELISE (contact); SMYSER, CHRISTOPHER DANIEL	St. Louis, MO	2019
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (Collaborative R34 Clinical Trial Not Allowed) NOFO Number: RFA-DA-19-029 Summary: Though prenatal exposure to opioids and other substances have adverse effects on neurodevelopment, advances in neuroimaging and developmentally sensitive phenotypic measurement now enable characterization of typical and atypical brain-behavior pathways on an unprecedented scale. The Brains Begin Before Birth (B4) Midwest Consortium, a partnership of neuroscience, substance use, perinatal mental health, and child welfare scientists at Washington University School of Medicine (WUSM) and neuroscience, bioethics, pediatric population health, maternal-fetal, and addiction scientists at Northwestern University (NU). This regional consortium will leverage the contrasting approaches of Illinois (punitive) and Missouri (non-punitive) to prenatal opioid use, providing a platform for examining the impact of jurisdictional variations on science and practice. The consortium provide a framework for addressing three major areas of challenge: (1) legal/ethical, (2) recruitment/retention, and (3) imaging/assessment methods.
1UG3DA047680-01 Show Summary	A novel therapeutic to ameliorate chronic pain and reduce opiate use	Novel Therapeutic Options for Opioid Use Disorder and Overdose	Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose	NIDA	LOHOCLA RESEARCH CORPORATION	TABAKOFF, BORIS	Aurora, CO	2019
NOFO Title: Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional) NOFO Number: RFA-DA-19-002 Summary: More than 100 million adults in the U.S. suffer from intermittent or constant chronic pain, and chronic pain affects at least 10 percent of the world’s population. The primary pharmaceuticals for treatment of chronic pain have been natural or synthetic opioids, and the use of opioids for pain treatment has resulted in what has been called an “epidemic” of opioid abuse, addiction, and lethal overdoses. Through a process of rational drug design, the research team has generated a new chemical entity (NCE) and have given it the name Kindolor, a non-opiate, non-addicting molecule that was shown to reduce or eliminate chronic pain in five animal models at doses compatible with use of Kindolor in humans. This project intends to complete the pre-clinical studies required for an IND application, which, if approved, would allow for proceeding onto the Phase 1 and 2 studies to assess safety and efficacy of the compound against osteoarthritic pain.
1UG3DA048768-01A1 Show Summary	Novel LAAM formulations to treat Opioid Use Disorder	Novel Therapeutic Options for Opioid Use Disorder and Overdose	Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose	NIDA	Virginia Commonwealth University	Xu, Qingguo	Richmond, VA	2019
NOFO Title: Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional) NOFO Number: RFA-DA-19-002 Summary: Levo-alpha-acetylmethadol (LAAM) offers numerous behavioral and clinical advantages for select opioid use disorder (OUD) patients who do not respond to standard treatment. While LAAM was withdrawn from the market despite being approved for OUD treatment, this project seeks to develop novel, patentable, convenient dosage forms of LAAM, including novel LAAM oral dosage formulations and novel buccal film formulations of LAAM. Morphology, mechanical property, drug release kinetics, and stability of the oral dosage and buccal film formulations will be characterized to determine the instant release or steady release of LAAM, respectively. The two lead LAAM formulations with adequate release and stability profiles will be chosen through optimization studies both in vitro and in vivo. A human pharmacokinetic/pharmacodynamic study will then be carried out on the two selected formulations.