Funded Projects

Explore our currently funded projects. You may search with all three fields, then focus your results by applying any of the dropdown filters. After customizing your search, you may download results and even save your specific search for later.

Project # Sort descending Project Title Research Focus Area Research Program Administering IC Institution(s) Investigator(s) Location(s) Year Awarded
1R61DA059880-01 Evaluation of a Peer Recovery Support Program Adapted to Target Retention in Clinic-Based Medication for Opioid Use Disorder Treatment Translation of Research to Practice for the Treatment of Opioid Addiction Optimizing the Quality, Reach, and Impact of Addiction Services NIDA GEISINGER CLINIC POULSEN, MELISSA (contact); ZAJAC, KRISTYN Danville, PA 2023
NOFO Title: HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-DA-23-053
Summary:

Medications for opioid use disorder (OUD) are safe and effective. However, many people do not take them long enough to achieve sustained recovery, putting them at risk of overdose. Peer recovery support services—which are delivered by trained individuals with lived experience of addiction and recovery—may help people with OUD initiate and stay in medication treatment. This project will adapt peer recovery support services for use in outpatient substance use treatment settings and test their implementation and effectiveness in helping people with OUD achieve long-term recovery. If successful, the program could be implemented in a variety of outpatient treatment programs, including in underserved rural areas.

1R61DA059887-01 Testing an Occupational Stress Intervention for Harm Reduction Workers in Substance Misuse Settings Translation of Research to Practice for the Treatment of Opioid Addiction Optimizing the Quality, Reach, and Impact of Addiction Services NIDA UNIVERSITY OF TEXAS AT AUSTIN CREECH, SUZANNAH K Austin, TX 2023
NOFO Title: HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-DA-23-053
Summary:

People who work in harm reduction settings aiming to keep people with substance use disorders safe from overdose and other negative health outcomes are exposed to high rates of lifetime and occupational stress and trauma. Their work conditions can have adverse effects on patient care and also on their own well-being, such as unmet mental health needs, burnout, and relapse. This project will adapt the Stress First Aid intervention for harm reduction workers. The research will test the impact of this intervention on social support, burnout, secondary traumatic stress, use of mental health care, engagement, and turnover. The long-term goal of this work is to implement a sustainable and effective national occupational stress intervention for harm reduction workers to strengthen their important role in helping individuals get treatment and avoid overdose.

1R61DA059889-01 Methadone Patient Access to Collaborative Treatment (MPACT) Translation of Research to Practice for the Treatment of Opioid Addiction Optimizing the Quality, Reach, and Impact of Addiction Services NIDA UNIVERSITY OF ARIZONA MEYERSON, BETH Tucson, AZ 2023
NOFO Title: HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-DA-23-053
Summary:

Current practices and culture in treatment programs for opioid use disorder, including treatment with methadone, may contribute to treatment interruption and relapse risk. This project will develop and test a staff-level intervention for opioid treatment programs to increase methadone treatment retention and decrease in-treatment overdose and patient- and staff-reported posttraumatic stress symptoms. The intervention includes components to address trauma in patients and staff as well as separate supervisory structures for counselors/case managers and medical providers.

1R61DA059892-01 Data-Driven Approaches for Opioid Use Disorder Treatment, Recovery, and Overdose Prevention in Rural Communities via Mobile Health Clinics and Peer Support Services Translation of Research to Practice for the Treatment of Opioid Addiction Optimizing the Quality, Reach, and Impact of Addiction Services NIDA CLEMSON UNIVERSITY RENNERT, LIOR (contact); LITWIN, ALAIN HARRIS Clemson, SC 2023
NOFO Title: HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-DA-23-053
Summary:

Although medication-based treatment for opioid use disorder (OUD) can effectively reduce overdose risk and improve health outcomes, most people discontinue treatment too soon. Peer support specialists, who are individuals with direct experience with a substance use disorder, can offer social support to help individuals with OUD overcome barriers to treatment and recovery. This project will develop, deliver, and evaluate an innovative peer support specialist intervention to help individuals begin and stay in a treatment program. The research will focus on rural populations and underserved communities, using a dynamic modeling framework to prioritize at-risk communities for treatment offered through mobile health clinics.

1R61DA059895-01 Promoting Retention in Opioid Treatment among Women Experiencing Intimate Partner Violence: A Novel Stepped Care Model Targeting PTSD Translation of Research to Practice for the Treatment of Opioid Addiction Optimizing the Quality, Reach, and Impact of Addiction Services NIDA YALE UNIVERSITY SULLIVAN, TAMI P (contact); EDELMAN, E JENNIFER; JOHNSON, DAWN M New Haven, CT 2023
NOFO Title: HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-DA-23-053
Summary:

Women with opioid use disorder (OUD) are disproportionately impacted by physical, sexual, and psychological intimate partner violence and posttraumatic stress disorder (PTSD). Yet, treatment approaches that address all these conditions together in OUD treatment settings are lacking. To address this gap, this project will evaluate delivery of two evidence-based interventions to address PTSD (Present-Centered Therapy+ and Helping to Overcome PTSD through Empowerment) for women seeking OUD treatment who have experienced intimate partner violence. It will also determine if integrated treatment can help retain the women in medication treatment for OUD.

1R61DA059897-01 Testing a Video and Text Messaging Intervention to Reduce PTSD and Opioid Misuse Among Sexual Violence Survivors Translation of Research to Practice for the Treatment of Opioid Addiction Optimizing the Quality, Reach, and Impact of Addiction Services NIDA UNIVERSITY OF WISCONSIN-MADISON WALSH, KATIE L Madison, WI 2023
NOFO Title: HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-DA-23-053
Summary:

People who survive sexual violence are at increased risk for posttraumatic stress disorder (PTSD) and opioid misuse. Emergency departments are often the first, and in some cases only, contact with the medical care system for survivors of sexual violence. This makes them a suitable setting to initiate interventions to address the risk of PTSD and opioid misuse in these individuals. This project will develop and test a brief, low-cost video and text message intervention that can be initiated in the emergency department to prevent onset or escalation of PTSD and opioid misuse among people who survive sexual violence.

1R61DA059947-01 Developing and Testing Innovative Care Pathways for Screening and Treatment of OUD/PTSD in Jails Translation of Research to Practice for the Treatment of Opioid Addiction Optimizing the Quality, Reach, and Impact of Addiction Services NIDA UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES ZIELINSKI, MELISSA JEAN (contact); ZALLER, NICKOLAS D Little Rock, AR 2023
NOFO Title: HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-DA-23-053
Summary:

Many people in jail have both opioid use disorder (OUD) and posttraumatic stress disorder (PTSD). Among people with OUD released from jail, only few engage in treatment and medication therapy once they are back in the community, and opioid overdose is a leading cause of death in this population. This project will test whether identifying and initiating treatment of PTSD in people receiving OUD treatment in jail can increase these individuals’ likelihood of starting and staying in medication treatment after release and thus reduce overdose risk.

1R61DA059948-01 Workforce and System Change to Treat Adolescent Opioid Use Disorder Within Integrated Pediatric Primary Care Translation of Research to Practice for the Treatment of Opioid Addiction Optimizing the Quality, Reach, and Impact of Addiction Services NIDA INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS HULVERSHORN, LESLIE A (contact); AALSMA, MATTHEW; ADAMS, ZACHARY WILLIAM Indianapolis, IN 2023
NOFO Title: HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-DA-23-053
Summary:

The overdose crisis has expanded rapidly among adolescent populations in recent years, largely due to illicit substances containing lethal amounts of the highly potent synthetic opioid fentanyl. However, a provider shortage limits access to effective treatment for adolescents with opioid use disorder and other substance use disorders (SUD). Although primary care is a promising setting for expanding delivery of SUD treatment to adolescents, many primary care providers lack the training, resources, and support systems to deliver these services confidently and effectively. This project will leverage a large-scale rollout of integrated behavioral health care in a statewide health system. The research will test whether embedding behavioral health specialists into primary care visits, introducing case management and electronic clinical decision support tools, and reducing stigma will increase delivery of SUD treatment to adolescents.

1R61HL156240-01 Treatment of Fentanyl Overdose-Induced Respiratory Failure by Low-Dose Dexmedetomidine Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NHLBI PENNSYLVANIA STATE UNIV HERSHEY MED CTR HAOUZI, PHILIPPE A Hershey, PA 2020
NOFO Title: HEAL Initiative: Pharmacotherapies to Reverse Opioid Overdose Induced Respiratory Depression without Central Opioid Withdrawal (Target Validation and Candidate Therapeutic Development (R61/R33 - Clinical Trial Not Allowed)
NOFO Number: RFA-HL-20-031
1R61HL156248-01 Intranasal Leptin as A Novel Treatment of Opioid-Induced Respiratory Depression Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NHLBI JOHNS HOPKINS UNIVERSITY POLOTSKY, VSEVOLOD Y Baltimore, MD 2020
NOFO Title: HEAL Initiative: Pharmacotherapies to Reverse Opioid Overdose Induced Respiratory Depression without Central Opioid Withdrawal (Target Validation and Candidate Therapeutic Development (R61/R33 - Clinical Trial Not Allowed)
NOFO Number: RFA-HL-20-031
1R61NR020845-01 Equity Using Interventions for Pain and Depression (EQUIPD) Clinical Research in Pain Management Advancing Health Equity in Pain Management NINR INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS MATTHIAS, MARIANNE Indianapolis, IN 2022
NOFO Title: HEAL Initiative: Advancing Health Equity in Pain and Comorbidities (R61/R33 Clinical Trial Required)
NOFO Number: RFA-NS-22-037
Summary:

Opioid overdose deaths disproportionately affect Black individuals in the United States. While the use of complementary and integrative pain treatments is effective and widely recommended, Black pain patients (especially those who also have depression) face barriers to the use of these approaches. This project will refine, test, and prepare to implement a novel approach to overcoming these treatment barriers. The research will partner with and empower Black patients to find safe, effective pain treatments that best match their values, preferences, and lifestyles.

1R61NS131307-01 Preclinical Assessment of a Novel Systemic Drug Candidate for Osteoarthritic Pain Preclinical and Translational Research in Pain Management Development and Optimization of Non-Addictive Therapies to Treat Pain NINDS UNIVERSITY OF SOUTHERN CALIFORNIA EVSEENKO, DENIS Los Angeles, CA 2023
NOFO Title: Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
NOFO Number: PAR-20-092
Summary:

Osteoarthritis is a degenerative joint disease marked by progressively worsening chronic joint pain that affects function and quality of life. Non-opioid, alternative medications are needed for people with this condition. Joint inflammation, damage, and pain involve signaling through the interleukin-6/glycoprotein 130 pathway. This project will test blocking this pathway in rodents with a new molecule with improved drug-like properties, toward developing an oral medication for osteoarthritis. 

1RF1DA050571-01A1 Reversing opioid-induced hypoxemia with novel thiol-based drugs without compromising analgesia in goats Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA MEDICAL COLLEGE OF WISCONSIN HODGES, MATTHEW ROBERT; FORSTER, HUBERT V Milwaukee, WI 2022
NOFO Number: PA-19-056
Summary:

Opioid overdoses result from reduced oxygen in the bloodstream. Although the opioid blocker naloxone can reverse the immediate harmful effects of opioids, it also has limitations. It does not last very long, blocks pain relief, and may induce withdrawal. This project will characterize and test the effectiveness of a novel, potent, and long-lasting respiratory stimulant. The study will use a freely behaving, large animal model with physiology similar to humans.

1RM1DA055301-01 Integrative Treatment for Achieving Holistic Recovery from Comorbid Chronic Pain and Opioid Use Disorder Clinical Research in Pain Management Reducing Opioid-Related Harms to Treat Chronic Pain (IMPOWR and MIRHIQL) NIDA UNIVERSITY OF NEW MEXICO WITKIEWITZ, KATIE A (contact); PEARSON, MATTHEW RYAN Albuquerque, NM 2021
NOFO Title: HEAL Initiative: Integrative Management of Chronic Pain and OUD for Whole Recovery (IMPOWR): Research Centers (RM1 Clinical Trial Required)
NOFO Number: RFA-DA-21-030
Summary:

There are a dearth of integrated treatments that simultaneously address the fundamental causes of chronic pain and opioid misuse/opioid use disorder and that focus on well-being among individuals with chronic pain and opioid misuse/disorder. This research will study how to improve the lives of patients with chronic pain and opioid misuse/disorder via tailored interventions that explicitly target increasing quality of life and engagement in valued activities, the cultural centering of interventions to meet the needs of diverse patient populations and reducing stigma of chronic pain and opioid misuse/disorder. Specific research projects will i) test the effectiveness, mechanisms, and implementation of an integrated psychosocial treatment for chronic pain and opioid use disorder among individuals receiving buprenorphine from outpatient treatment clinics, and ii) will use community-based participatory research methods to develop a culturally centered strategy for screening and brief intervention of chronic pain and opioid use disorder among American Indian/Alaska Native patients in primary care settings. This research will shed light on a difficult problem and improve health and wellbeing with a focus on diverse and underserved populations.

1RM1DA055310-01 HEAL Initiative: Integrative Management of Chronic Pain and OUD for Whole Recovery (IMPOWR): Research Centers Clinical Research in Pain Management Reducing Opioid-Related Harms to Treat Chronic Pain (IMPOWR and MIRHIQL) NIDA YALE UNIVERSITY BECKER, WILLIAM C (contact); BARRY, DECLAN T; FIELLIN, DAVID New Haven, CT 2021
NOFO Title: HEAL Initiative: Integrative Management of Chronic Pain and OUD for Whole Recovery (IMPOWR): Research Centers (RM1 Clinical Trial Required)
NOFO Number: RFA-DA-21-030
Summary:

Health care services for patients with both chronic pain and opioid use disorder are fragmented in the United States. To develop effective and feasible interventions for chronic pain and opioid misuse/disorder that can be implemented in both general medical and addiction treatment settings, this research examines two different care-delivery strategies. The first project will compare the effectiveness of a pharmacist-led, collaborative care approach for patients prescribed long-term opioids who have chronic pain and  opioid misuse/disorder compared to a pharmacist program with a cognitive behavior therapy-based pain self-management program. The second project will examine the effectiveness of a multimodal, interdisciplinary chronic pain management program that includes cognitive behavioral therapy, exercise, and stress management. With input from stakeholders and individuals with lived experience, this research has the potential to generate novel, reproducible, and scalable findings that addresses fragmented care delivery for co-occurring chronic pain and opioid misuse/disorder.

1RM1DA055311-01 Tailored Retention and Engagement for Equitable Treatment of OUD and Pain (TREETOP) Clinical Research in Pain Management Reducing Opioid-Related Harms to Treat Chronic Pain (IMPOWR and MIRHIQL) NIDA UNIVERSITY OF PITTSBURGH AT PITTSBURGH MERLIN, JESSICA S (contact); HAMM, MEGAN ; KRAEMER, KEVIN L Pittsburgh, PA 2021
NOFO Title: HEAL Initiative: Integrative Management of Chronic Pain and OUD for Whole Recovery (IMPOWR): Research Centers (RM1 Clinical Trial Required)
NOFO Number: RFA-DA-21-030
Summary:

The goal of the Tailored Retention and Engagement for Equitable Treatment of Opioid use disorder (OUD) and Pain (TREETOP) research program is to develop effective, equitable, and sustainable interventions for chronic pain and opioid misuse/disorder that improve engagement in medication for opioid misuse/disorder treatment and retention in office-based addiction treatment. TREETOP will prioritize disproportionately affected rural and Black communities. The Engagement research project will investigate whether pain self-management can improve pain and engage primary care patients to seek medication treatment for opioid misuse/disorder. The Retention project will investigate whether pain self-management and/or flexibly dosed buprenorphine/naloxone can improve pain and retention in treatment among patients who have already begun care in office-based addiction treatment programs. With engagement from stakeholders and representatives with varied perspectives and lived experiences, this research will advance the science of sustainably and equitably managing chronic pain and opioid misuse/disorder, prioritizing disproportionately affected communities.

1RM1DA055437-01 Integrated Care for Chronic Pain and Opioid Use Disorder: The IMPOWR Research Center at Montefiore/Einstein (IMPOWR-ME) Clinical Research in Pain Management Reducing Opioid-Related Harms to Treat Chronic Pain (IMPOWR and MIRHIQL) NIDA ALBERT EINSTEIN COLLEGE OF MEDICINE STARRELS, JOANNA L (contact); ARNSTEN, JULIA H; GABBAY, VILMA Bronx, NY 2021
NOFO Title: HEAL Initiative: Integrative Management of Chronic Pain and OUD for Whole Recovery (IMPOWR): Research Centers (RM1 Clinical Trial Required)
NOFO Number: RFA-DA-21-030
Summary:

Chronic pain and opioid use disorder often occur together, but there are a striking lack of integrated treatments accessible to people in need, particularly Black and Hispanic individuals living and seeking care in under resourced settings. This research will examine multi-modal, evidence-based practices in diverse health care settings and among diverse populations with both chronic pain and opioid misuse/disorder. The first project will examine the effects of yoga and physical therapy onsite at methadone opioid treatment clinics. The second project will test Acceptance and Commitment Therapy and a care-management smartphone app for individuals in primary-care based buprenorphine treatment. The third project will compare microdosing versus standard doses/timing of buprenorphine for hospitalized patients. All three projects will improve access to care for Black and Hispanic individuals in under resourced settings by bringing integrated treatments to them. The interventions have high potential to be used broadly.

1RM1DA059365-01 Improving Quality and Equity of Opioid Use Disorder Treatment Using a Multi-State Medicaid Research Network Translation of Research to Practice for the Treatment of Opioid Addiction Optimizing the Quality, Reach, and Impact of Addiction Services NIDA UNIVERSITY OF PITTSBURGH AT PITTSBURGH DONOHUE, JULIE MARIE (contact); BARNES, ANDREW JAMES Pittsburgh, PA 2023
NOFO Title: HEAL Initiative: Research to Foster an Opioid Use Disorder Treatment System Patients Can Count On (RM1 - Clinical Trial Optional)
NOFO Number: RFA-DA-23-046
Summary:

Medicaid covers the cost of treatment for opioid use disorder (OUD) for most individuals who need it, including minoritized populations and those with risk factors related to low income, education, and employment. The Medicaid Outcomes Distributed Research Network has supported efforts to improve OUD treatment by developing novel measures of treatment quality and examining effects of treatment quality on overdoses. Using this network, this project will leverage university-state partnerships in 12 states to inform quality improvement initiatives and Medicaid policy. The research will develop provider-level quality measures for OUD using Medicaid administrative data and measure patient-reported outcomes. The research will also look for approaches to use claims-based quality measures and practice-level quality improvement strategies to improve treatment outcomes for people with OUD.

1RM1DA059375-01 HEAL Initiative: Research to Foster an Opioid Use Disorder Treatment System Patients Can Count On Translation of Research to Practice for the Treatment of Opioid Addiction Optimizing the Quality, Reach, and Impact of Addiction Services NIDA RESEARCH TRIANGLE INSTITUTE MARK, TAMI L Research Triangle Park, NC 2023
NOFO Title: HEAL Initiative: Research to Foster an Opioid Use Disorder Treatment System Patients Can Count On (RM1 - Clinical Trial Optional)
NOFO Number: RFA-DA-23-046
Summary:

Although medication-based treatment for opioid use disorder can effectively reduce overdose risk and improve health outcomes, most people discontinue treatment too soon. Quality measures that inform opioid treatment programs about how many patients remain in treatment relative to peer programs could motivate those programs to pursue quality improvement activities, such as helping patients navigate logistical barriers to receiving treatment. This project will test approaches to developing and disseminating retention and outcome measures for opioid treatment programs.

1RM1DA059377-01 Person-Centered Quality Measurement and Management in a System for Addictions Treatment in New York State Translation of Research to Practice for the Treatment of Opioid Addiction Optimizing the Quality, Reach, and Impact of Addiction Services NIDA NEW YORK UNIVERSITY SCHOOL OF MEDICINE NEIGHBORS, CHARLES J (contact); BURKE, CONSTANCE; LINCOURT, PATRICIA New York, NY 2023
NOFO Title: HEAL Initiative: Research to Foster an Opioid Use Disorder Treatment System Patients Can Count On (RM1 - Clinical Trial Optional)
NOFO Number: RFA-DA-23-046
Summary:

The number of drug overdoses in New York continues to rise. In response, the New York State Office of Addiction Services and Supports (OASAS) is promoting approaches that embrace person-centered care, evidence-based practices, equitable treatment, and harm-reduction principles. In this project, researchers will partner with OASAS to build a quality measurement and management research center that provides performance feedback to support and encourage leadership and staff of treatment clinics to improve practice. The center will also publicize quality measures to ensure public accountability.

1U01DA047713-01 PTPRD ligands for stimulant and opiate use disorders Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA BIOMEDICAL RESEARCH INSTITUTE OF NEW MEX Uhl, George Richard Albuquerque, NM 2019
NOFO Title: Grand Opportunity in Medications Development for Substance-Use Disorders (U01 Clinical Trial Optional)
NOFO Number: PAR-18-219
Summary:

There are no FDA-approved medications for stimulant use disorders, and therapies for opioid use disorders remain suboptimal in ways that are now a focus of national attention. Thus, there is a clear need to identify new targets and explore new approaches for addiction medication development. Several lines of evidence suggest that PTPRD (receptor type protein tyrosine phosphatase D) may be a promising target for development of pharmacotherapeutics to treat not only stimulant use disorders but opioid use disorders as well. This research will focus on improving existing PTPRD ligands, identifying their effects on the dopamine and opioid systems, and moving the best novel, patentable PTPRD ligands toward human studies. If successful, this project will generate novel, well-tolerated, and bioavailable PTPRD ligands that display in vitro potency, selectivity and stability, and in vivo modulation of both cocaine and opioid-mediated reward at doses that present no significant toxicity.

1U01DA047982-01 Long-acting buprenorphine vs. naltrexone opioid treatments in CJS-involved adults Translation of Research to Practice for the Treatment of Opioid Addiction Justice Community Opioid Innovation Network (JCOIN) NIDA NEW YORK UNIVERSITY SCHOOL OF MEDICINE LEE, JOSHUA D; FARABEE, DAVID J; MARSCH, LISA A; SCHWARTZ, ROBERT P; SPRINGER, SANDRA ANN; WADDELL, ELIZABETH NEEDHAM New York, NY 2019
NOFO Title: HEAL Initiative: Justice Community Opioid Innovation Network (JCOIN) Clinical Research Centers (UG1 Clinical Trial Optional)
NOFO Number: RFA-DA-19-025
Summary:

This study will assess the implementation of an evidence-based treatment in correctional settings by comparing the effectiveness of two medications used to treat opioid use disorder—extended-release buprenorphine (XR-B) vs. extended-release naltrexone (XR-NTX)—among adults currently incarcerated in U.S. jails and prisons at five distinct trial sites. This study will allow providers, correctional and public health authorities, payers, and policymakers’ timely and relevant data to assess the effectiveness of these medications as potentially useful re-entry treatment options. Findings from this study have implications for expanding public safety and limiting the societal costs of heroin, fentanyl, and prescription opioid addictions.

1U01DA050442-01 Using Implementation Interventions and Peer Recovery Support to Improve Opioid Treatment Outcomes in Community Supervision Translation of Research to Practice for the Treatment of Opioid Addiction Justice Community Opioid Innovation Network (JCOIN) NIDA BROWN UNIVERSITY MARTIN, ROSEMARIE A; BRINKLEY-RUBINSTEIN, LAUREN ; ROHSENOW, DAMARIS J Providence, RI 2019
NOFO Title: HEAL Initiative: Justice Community Opioid Innovation Network (JCOIN) Clinical Research Centers (UG1 Clinical Trial Optional)
NOFO Number: RFA-DA-19-025
Summary:

Individuals who have been previously incarcerated have a significantly higher risk of dying from opioid overdose, particularly in the first two weeks after release. Providing medication for opioid use disorder (MOUD) to individuals on probation or parole decreases the rate of relapse and recidivism, and increases retention in substance abuse treatment. This study will test a systems-change approach for increasing use of MOUD across a network of seven probation and parole sites to improve linkage to the continuum of evidence-based care for justice-involved individuals. Implementation outcomes include program acceptability, adoption, penetration, sustainability, and costs. Client-level effectiveness outcomes include retention, satisfaction, opioid use, opioid overdoses, recidivism, linkage to OUD treatment, and utilization of recovery services. Targeting the intersection of justice and community-based care has substantial potential for addressing the opioid crisis.

1U01DA051071-01A1 Process Development, Manufacturing, and Preclinical Evaluation of a Monoclonal Antibody for Fentanyl Overdose Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA CESSATION THERAPEUTICS, LLC Bremer, Paul T. San Jose, CA 2020
NOFO Title: Grand Opportunity in Medications Development for Substance-Use Disorders (U01 - Clinical Trial Optional)
NOFO Number: PAR-19-327
Summary:

Opioid use disorder (OUD) is a significant public health problem in the United States. Particularly troubling is the rapid evolution of an opioid epidemic within the past decade, characterized by a surge in unintentional overdose deaths involving synthetic opioids, such as fentanyl. The current standard of care for opioid overdose is reversal with opioid antagonist naloxone. Naloxone is effective at reversing overdose from prescription opioids and heroin, but less effective when combating fentanyl, due to fentanyl?s high potency. Therapeutic monoclonal antibodies (mAbs) against fentanyl could overcome this problem by specifically preventing the drug from entering the central nervous system, averting overdose and attenuating opioid-induced respiratory depression. This study will develop and design of laboratory protocols needed to establish a Good Manufacturing Practice (GMP) process, quality assurance protocol, and stability profile for a new human mAb against fentanyl. Subsequent production of current GMP material will enable Good Laboratory Practice (GLP) toxicology studies in rats and dogs and eventually a Phase I/IIa clinical trial. This material will also be used in final opioid-induced respiratory depression studies in mice and non-human primates to confirm therapeutic efficacy of final drug product. If successful, these activities will enable filing for an investigational new drug application for this mAb candidate with the FDA.

1U01DA055316-01 16/24 Healthy Brain and Child Development National Consortium Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA UNIV OF MARYLAND, COLLEGE PARK FOX, NATHAN A (contact); HARDEN, BRENDA J; RIGGINS, TRACY L College Park, MD 2021
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-020
Summary:

The HEALthy Brain and Child Development National Consortium (HBCD-NC) will establish a normative model of developmental trajectories over the first 10 years of life. All sites in the HBCD-NC will carry out a common research protocol and will assemble and distribute a comprehensive research dataset to the scientific community. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. Most participants will be recruited in the second trimester of pregnancy, with a smaller subset recruited at birth, and followed for the first 10 years of life. The University of Maryland College Park study site is midway between Washington, DC, and Baltimore, Maryland, and will recruit a diverse sample of mother-infant pairs from across the region.