Funded Projects

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Project # Project Title Research Focus Area Research Program Administering IC Institution(s) Investigator(s) Location(s) Year Awarded
1R01DA056673-01
Targeting Tiam1-Mediated Synaptic Plasticity for the Relief of Opioid Tolerance Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA Baylor College of Medicine LI, LINGYONG (contact); TOLIAS, KIMBERLY Houston, TX 2022
NOFO Title: HEAL Initiative: Novel Targets for Opioid Use Disorders and Opioid Overdose (R01 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-22-031
Summary:

Chronic opioid use results in tolerance, a primary driver for opioid misuse and overdose that directly contribute to increased morbidity and mortality. Changes in neuronal connectivity known as synaptic plasticity are a key determinant of opioid tolerance, but the underlying molecular mechanisms remain unclear. Tiam1 is a protein known to control the development of nerve cells and their connections and is also involved in morphine-induced neuronal changes. This research will examine Tiam1-mediated synaptic plasticity underlying opioid tolerance and validate Tiam1 as a potential therapeutic target for prevention of tolerance development.
3UG3DA047793-01S1
tDCS to decrease opioid relapse Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA BUTLER HOSPITAL (PROVIDENCE, RI) Abrantes, Ana M Providence, RI 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

Neurostimulation techniques, such as transcranial direct current stimulation (tDCS), have been used as interventions for substance use disorders. This is a supplement to the currently NIDA-funded UG3 DA047793, “tDCS to Decrease Opioid Relapse,” which will measure behavioral and brain responses following tDCS stimulation delivered during tasks that use a particular brain network involved in cognitive control, and utilizing FMRI to assess the effects. This supplement allows the researchers to add an EEG measurement to the study, to get a complete picture of how tDCS might affect the function of key brain networks in ways that could be helpful for SUDs.
1UG3DA047793-01
TDCS TO DECREASE OPIOID RELAPSE New Strategies to Prevent and Treat Opioid Addiction Translational Research to Advance Testing of Novel Drugs and Human Cell-Based Screening Platforms to Treat Pain and Opioid Use Disorder NIDA Butler Hospital ABRANTES, ANA M.; STEIN, MICHAEL D PROVIDENCE, RI 2018
NOFO Title: Device-Based Treatments for Substance Use Disorders (UG3/UH3, Clinical Trial Optional)
NOFO Number: PAR-18-494
Summary:

Neurostimulation techniques, such as transcranial direct current stimulation (tDCS), have been used as interventions for substance use disorders. This is a supplement to the currently NIDA-funded UG3 DA047793, “tDCS to Decrease Opioid Relapse,” which will measure behavioral and brain responses following tDCS stimulation delivered during tasks that use a particular brain network involved in cognitive control, and utilizing FMRI to assess the effects. This supplement allows the researchers to add an EEG measurement to the study, to get a complete picture of how tDCS might affect the function of key brain networks in ways that could be helpful for SUDs.
1R01DA057633-01
Teaching Harm Reduction in Vulnerable Environments (THRIVE): A Peer-Led Intervention Bridging Acute Care Settings and the Discharge to the Community Translation of Research to Practice for the Treatment of Opioid Addiction Harm Reduction Approaches to Reduce Overdose Deaths NIDA UNIVERSITY OF PITTSBURGH WILSON, JACQUELINE DEANNA Pittsburgh, PA 2022
NOFO Title: HEAL Initiative: Harm Reduction Policies, Practices, and Modes of Delivery for Persons with Substance Use Disorders (R01 Clinical Trial Optional)
NOFO Number: RFA-DA-22-046
Summary:

People who use drugs often have other medical problems that cause them to visit an emergency department frequently. This project will develop and test an intervention aimed at reducing health risk among Black people who use drugs that visit an urban emergency department for care. The intervention will be delivered by people with lived experience of drug use and tailored to meet the unique needs of Black people who use drugs.
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.
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.
1R61AT010604-01
Testing the Effects of Contingency Management and Behavioral Economics on Buprenorphine-Naloxone Treatment Adherence Using a Sequential Multiple Assignment Randomized Trial (SMART) Design Translation of Research to Practice for the Treatment of Opioid Addiction Behavioral Research to Improve Medication-Based Treatment NCCIH University of Tennessee DEREFINKO, KAREN J Knoxville, TN 2019
NOFO Title: HEAL Initiative: Behavioral Research to Improve MAT: Behavioral and Social Interventions to Improve Adherence to Medication Assisted Treatment for Opioid Use Disorders (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-AT-19-006
Summary:

This application will develop and execute a sequential multiple assignment randomized trial (SMART) design to test two forms of behavioral economics intervention to promote medication-assisted treatment (MAT) for opioid use disorder. The two interventions, in person, brief motivational interviewing and substance-free activities intervention (BMI+SFAS), initially will be tested for satisfaction and acceptability with participants who are initiating buprenorphine-naloxone treatment and then be tested by SMART for its ability to promote MAT adherence. This innovative SMART design that tests two psychosocial interventions to increase adherence to MAT initiation is likely to have a significant impact on engagement of opioid use disorder patients in treatment and address an underserved population with opioid use disorder who is resistant to MAT adherence.
1U01HL150596-01
The Collaboration Linking Opioid Use Disorder and Sleep ("CLOUDS") Study New Strategies to Prevent and Treat Opioid Addiction Sleep Dysfunction as a Core Feature of Opioid Use Disorder and Recovery NHLBI Yale University YAGGI, HENRY KLAR (contact); BARRY, DECLAN T; REDEKER, NANCY S; SCHEINOST, DUSTIN New Haven, CT 2019
NOFO Title: HEAL Initiative: Sleep and Circadian-Dependent Mechanisms Contributing to Opiate Use Disorder (OUD) and Response to Medication Assisted Treatment (MAT) (U01 Clinical Trial Optional)
NOFO Number: RFA-HL-19-029
Summary:

Opioid use disorder (OUD) is a chronic and relapsing brain disease that affects over 2 million Americans. Despite effective evidence-based treatments in the form of behavioral interventions and FDA-approved medication for addiction treatment (MAT), relapse rates are high. The Collaboration Linking Opioid Use Disorder and Sleep Study will investigate patients on MAT to elucidate potential causal mechanisms between sleep deficiency and OUD. The aims of this study are to 1) test whether there are different neurocognitive connectivity patterns between patients with adequate vs. deficient sleep in brain systems involved in addiction and assess the extent to which these “neural fingerprints” predict ongoing opioid use; 2) evaluate the potential biologic, psychiatric, and pharmacologic mechanisms that explain the causal pathway between sleep deficiency and opioid use; and 3) test ecologic factors such as psychosocial, family, and neighborhood contextual factors associated with OUD and their contribution to sleep deficiency among patients in MAT.
1R34DA050286-01
The Cumulative Risk of Substance Exposure and Early Life Adversity on Child Health Development and Outcomes Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA FATHER FLANAGAN'S BOYS' HOME BLAIR, JAMES Boys Town, NE 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:

Despite increased efforts to understand the neurodevelopmental sequelae of in utero opioid and other substance exposure on long-term behavioral, cognitive, and societal outcomes, important questions remain, specifically, 1) How is brain growth disrupted by fetal substance and related pre- and post-natal exposures? and 2) How are these disrupted growth patterns causally related to later cognitive and behavioral outcomes? This project seeks to formulate an approach to addressing these key questions and decipher the individual and cumulative effect of these intertwined pre- and post-natal exposures on child neurodevelopment. First, researchers will address the legal, ethical, and mother-child care and support concerns implicit in this study. Next, they will integrate across our areas of neuroimaging expertise to develop, implement, and harmonize a multi-modal MRI and EEG protocol to assess maturing brain structure, function, and connectivity. Finally, researchers will develop and test advanced statistical approaches to model and analyze this multidimensional and longitudinal data.
1UG3DA053094-01A1
The Development of Delta Opioid Receptor Agonists for the Treatment of Opioid Withdrawal Associated Behaviors Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA UNIVERSITY OF ILLINOIS AT CHICAGO PRADHAN, AMYNAH AMIR ALI Chicago, IL 2022
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:

This project aims to develop a new way to stimulate the delta opioid receptor to treat withdrawal and abstinence from chronic opioid use. Withdrawal can cause pain, depression, and anxiety, which contribute to relapse. The research will test promising drug candidates in animal models with the intention of bringing at least one effective and safe compound to the final stage of drug development before human clinical trials can begin.
1U24DA055325-01
The Healthy Brain and Child Development National Consortium Administrative Core Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA UNIVERSITY OF CALIFORNIA, SAN DIEGO CHAMBERS, CHRISTINA (contact); NELSON, CHARLES ALEXANDER La Jolla, CA 2021
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Consortium Administrative Core (U24 - Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-022
Summary:

The HEALthy Brain and Child Development National Consortium (HBCD-NC) Administrative Core (HCAC) will coordinate efforts across all sites in the HBCD-NC consortium to ensure that the consortium meets its primary objective to establish a normative model of developmental trajectories over the first 10 years of life. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. The HCAC will oversee study design and monitor the progress of each site’s ability to carry out a common research protocol and will assemble and distribute a comprehensive research dataset to the scientific community. This administrative core is located at the University of California, San Diego.
1R01DA059371-01
The Impact of Community Infrastructure Reinvestment Programs on Opioid Misuse and Opioid Overdose New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA UNIVERSITY OF PENNSYLVANIA NESOFF, ELIZABETH Philadelphia, PA 2023
NOFO Title: HEAL Initiative: Preventing Opioid Misuse and Co-Occurring Conditions by Intervening on Social Determinants (R01 - Clinical Trials Optional)
NOFO Number: RFA-DA-23-051
Summary:

Urban neighborhood deterioration (also known as blight) can affect individual and community health. Interventions have shown positive effects on neighborhood crime, gun violence, and mental health. In Philadelphia, government and community partnerships have remediated vacant lots and abandoned buildings to improve living conditions. This project will investigate the degree to which neighborhood improvement interventions in Philadelphia affect opioid misuse and overdose risk for residents. Results from this research could inform similar public health-based policy and community-level health interventions in other cities.
1UG3DA048375-01
The long-term reduction of pain and opioid usage following mastectomy and tissue expander/implant surgery with a single administration of brivoligide, a non-opioid, disease-modifying drug candidate Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA ADYNXX, INC. MAMET, JULIEN; MANNING, DONALD C San Francisco, CA 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:

There is an urgent need to prevent and reduce opioid use disorder (OUD) by reducing the need for opioid analgesia and preventing the escalation of opioid dosing in patients at greater risk of using more opioids following surgery. Brivoligide is a non-opioid drug candidate that can alter the course of postoperative pain for patients most likely to suffer increased pain and utilize more opioids following surgery. A single administration of brivoligide at the time of surgery can reduce acute postoperative pain in these patients by 30 percent to 40 percent beyond what can be achieved with the current standard of care for at least 28 days and reduce opioid utilization by 40 percent over a 3-month period following surgery. This project will support the research necessary to achieve regulatory approval of brivoligide with a broad indication, which will initially focus on the reduction of postoperative pain following mastectomy, a soft-tissue surgery model suitable to detect long-term pain and opioid reduction benefits. Brivoligide appears to be a very promising pharmacotherapy with the potential to greatly contribute to stemming the tide in the opioid crisis.
3R61DA049382-02S2
The moderation effect of social support networks on the relationship between opioid use and suicide attempts among Native American youth in New Mexico New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA UNIVERSITY OF UTAH QEADAN, FARES Salt Lake City, UT 2020
NOFO Title: Notice of Special Interest(NOSI): HEAL Initiative: Social Network Analyses to Reduce American Indian and Alaska Native Opioid Use Disorder and Related Risks for Suicide and Mental Health Disorders
NOFO Number: NOT-DA-20-033
Summary:

Fatal opioid overdose rates are higher among American Indian/Alaska Native populations than among Hispanics, African Americans, and Asian Americans, and are just below non-Hispanic Whites. AI/AN opioid overdose rates vary significantly by state and county; however, tribe-level differences are difficult to ascertain due to decentralized data systems that divide state health data and Indian Health Service data. This study will conduct a two-phase research project that leverages Center for Disease Control funding awarded to the Albuquerque Area Southwest Tribal Epidemiology Center for improving data quality in opioid overdose surveillance in New Mexico. In the first phase, geocoding and data linkages will be studied to address the need in New Mexico for tribe-specific data and analyses on opioid use disorder and opioid overdose. After disseminating analyses to tribal communities and Indian Health Service, Tribal and Urban Indian health facilities, the second phase of the study will establish a collaboration with interested tribes and facilities in a community-based participatory intervention research project to develop and test a culturally centered implementation program for providing medication for opioid use disorders to American Indian people.
3UH3DA050251-03S1
The Role of Family Functioning and Race/Ethnicity on the Efficacy of an Opioid Misuse Prevention Videogame Intervention for Adolescents New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA YALE UNIVERSITY FIELLIN, LYNN ELIZABETH New Haven, CT 2021
NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for PA-20-222: Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)
NOFO Number: NOT-NS-20-107
Summary:

Most opioid misuse begins during adolescence and young adulthood. Adolescence is the best time for prevention interventions in settings like school-based health centers (HCs), yet few programs focus on preventing initiation of opioid misuse. This study harnesses the power of video game interventions and incorporates components of effective substance use prevention programs to develop an evidence-informed intervention to prevent the initiation of opioid misuse in adolescents. In partnership with the national School-Based Health Alliance (SBHA), researchers will develop and test a new video game intervention, PlaySmart. It will build on our previous video game intervention that has demonstrated efficacy in improving attitudes and knowledge related to risk behaviors. The study will evaluate the game in a randomized controlled trial in 10 school-based HCs and examine strategies for implementing PlaySmart in school-based HCs nationally. This research has considerable potential for wide implementation, reach, and impact on high-risk adolescents through school-based HCs.
1R21NS130417-01
The Role of Lysosomal Mechano-Sensitive Ion Channel in Pain Preclinical and Translational Research in Pain Management Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain NINDS INDIANA UNIVERSITY PURDUE AT INDIANAPOLIS TAN, ZHIYONG Indianapolis, IN 2022
NOFO Title: Emergency Awards: HEAL Initiative-Early-Stage Discovery of New Pain and Opioid Use Disorder Targets Within the Understudied Druggable Proteome (R21 Clinical Trial Not Allowed)
NOFO Number: TR22-011
Summary:

Chronic pain severely reduces the quality of life and ability to work for millions of Americans. Because misuse of opioids for chronic pain treatment contributes to opioid addiction and opioid overdose, there is an urgent need to study novel non-opioid mechanisms, targets, and treatment strategies for chronic pain. Many ion channels control the flow of electrical signals in peripheral sensory neurons and are thus key targets for understanding and treating chronic pain. This project will conduct detailed studies to identify major ion channel-related molecular activities, targets, and treatment strategies for chronic pain. In particular, this research will explore the role of a specific ion channel (lysosomal mechanosensitive ion channel, orTmem63A) in neuropathic pain resulting from nerve injury.
3R01DA042059-04S2
THE SAFETY AND IMPACT OF EXPANDED ACCESS TO NALOXONE IN HEALTH SYSTEMS New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA Kaiser Foundation Research Institute BINSWNGER, INGRID A Oakland, CA 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
1R01DA057673-01
The Short and Long-Term Dynamics of Opioid/Stimulant Use: Mixed Methods to Inform Overdose Prevention and Treatment Related to Polysubstance Use Translation of Research to Practice for the Treatment of Opioid Addiction Improving Delivery of Healthcare Services for Polysubstance Use NIDA JOHNS HOPKINS UNIVERSITY GENBERG, BECKY LYNN (contact); GERMAN, DANIELLE Baltimore, MD 2022
NOFO Title: HEAL Initiative: Understanding Polysubstance Use and Improving Service Delivery to Address Polysubstance Use (R01 Clinical Trial Optional)
NOFO Number: DA22-047
Summary:

Use of both opioids and stimulants is increasing, but little is known about how polysubstance use evolves over time and how it influences overdose risk. This project will use data from two groups at high risk for overdose: i) participants in the AIDS Linked to the IntraVenous Experience (ALIVE) study who inject drugs and ii)  participants in the new Stimulant Opioid Non-Injection Cohort (SONIC) study. This research will identify drug use patterns and their association with treatment and overdose over time – toward informing overdose prevention efforts and interventions to improve the U.S. opioid crisis.
1R61DA059168-01
The Use of Novel Linked Databases to Reduce Postoperative Opioid Use Among Patients Undergoing Inpatient Surgery Cross-Cutting Research Translating Data 2 Action to Prevent Overdose NIDA STANDFORD UNIVERSITY SUN, ERIC (contact); COLQUHOUN, DOUGLAS ALASTAIR Stanford, CA 2023
NOFO Title: HEAL Initiative: HEAL Data2Action – Innovation and Acceleration Projects, Phased Awards (R61/R33, Clinical Trial Optional)
NOFO Number: RFA-DA-23-057
Summary:

Older adults make up more than half of all surgical patients in the United States, putting them at risk for a range of harmful outcomes including misusing opioids, developing opioid use disorder (OUD), opioid overdose, and surgical complications. This project seeks to understand whether pre-surgery interventions can prevent harmful opioid-related outcomes. The research will combine data from a registry of electronic health records and from Medicare claims data to learn about the relationship between these interventions and opioid-related outcomes including persistent opioid use, OUD, and other harmful outcomes.
1UF1MH121944-01
The Whole Health Study: Collaborative Care for OUD and Mental Health Conditions New Strategies to Prevent and Treat Opioid Addiction Optimizing Care for People with Opioid Use Disorder and Mental Health Conditions NIMH UNIVERSITY OF PENNSYLVANIA MANDELL, DAVID S (contact); BOGNER, HILLARY R; KAMPMAN, KYLE MATTHEW Philadelphia, PA 2019
NOFO Title: HEAL Initiative: Effectiveness Trials to Optimize, Implement, Scale, and Sustain the Collaborative Care Model for Individuals with Opioid Use Disorders and Mental Health Conditions (U01 Clinical Trial Required)
NOFO Number: RFA-MH-19-525
Summary:

This study will refine and test a collaborative care model for patients with opioid use disorder (OUD) and major depression, post-traumatic stress disorder, or an anxiety disorder in primary care. The primary aims of the study are: (1) prototype and test elements of the research team’s collaborative care models; (2) conduct a randomized study of three collaborative care conditions to determine which is most effective in improving outcomes for people with OUD and mental health conditions: Augmented Usual Care, Collaborative Care, or Collaborative Care + Social Worker; (3) measure clinician and organizational-level factors associated with implementation to increase success; (4) conduct a cost evaluation of each collaborative care model; and (5) work with smaller and rural practices to develop and test effective strategies to manage OUD. Successful completion of this study will provide evidence regarding the elements of integrated collaborative care required to maximize outcomes for individuals with OUD and psychiatric disorders.
1R61AT010614-01
The Youth Opioid Recovery Support (YORS) Intervention: An assertive community treatment model for improving medication adherence in young adults with opioid use disorder Translation of Research to Practice for the Treatment of Opioid Addiction Behavioral Research to Improve Medication-Based Treatment NCCIH Maryland Treatment Centers FISHMAN, MARC Baltimore, MD 2019
NOFO Title: HEAL Initiative: Behavioral Research to Improve MAT: Behavioral and Social Interventions to Improve Adherence to Medication Assisted Treatment for Opioid Use Disorders (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-AT-19-006
Summary:

Young people are disproportionately affected by the opioid crisis due to lack of access to medications for opioid use disorder (OUD) and poor adherence to these treatments. The Youth Opioid Recovery Support (YORS) model is an innovative wraparound approach that attempts to address barriers to treatment engagement in the young adult population, especially difficulties with medication adherence. The YORS model components include home delivery of extended-release naltrexone for OUD, engagement of families in collaborative treatment planning and monitoring focusing on medication adherence, assertive outreach from the treatment team by text messaging and social media to promote engagement and adherence, and contingency management to provide incentives for medication adherence. If the refining and testing demonstrates the efficacy of the YORS intervention, future work could include an economic analysis, a larger multisite study, longer intervention duration, study of extended-release buprenorphine, and study of step-down to less intensive interventions.
1UG1HD107628-01
Thomas Jefferson University Hospital Clinical Site for HEAL NOWS Pharmacologic Trial Enhanced Outcomes for Infants and Children Exposed to Opioids Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) NICHD THOMAS JEFFERSON UNIVERSITY  (PA) KRAFT, WALTER K (contact); ADENIYI-JONES, SUSAN Philadelphia, PA 2021
NOFO Title: HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial - Clinical Sites (UG1 Clinical Trial Required)
NOFO Number: RFA-HD-21-031
Summary:

Neonatal Opioid Withdrawal Syndrome (NOWS) is a condition that occurs when newborns are exposed to opioids during pregnancy. Symptoms often include tremors, excessive crying, sleep deprivation, and swallowing difficulties. Cases are rising, with a newborn affected by NOWS approximately every 15 minutes. Currently, healthcare providers in the United States lack standard, evidence-based treatments for NOWS. 

This project is part of a multi-center, randomized controlled clinical trial that directly compares NOWS treatments—morphine, methadone, and buprenorphine—and takes into account other types of non-drug therapies, such as behavioral interventions. The goal is to generate results that can inform clinical practice guidelines and give newborns with NOWS the best start possible. 

Thomas Jefferson University has more than 40 years of experience optimizing approaches to the care of opioid use disorder in pregnancy and conducts clinical research on NOWS treatments. The hospital provides a robust continuum of care that supports women with opioid use disorders before, during, and after delivery. This supportive culture has resulted in a relatively high rate of clinical trial participation that will enable long-term follow up of mothers and infants.
1UG3DA059407-01
Towards Treatment for the Complex Patient: Investigations of Low-Intensity Focused Ultrasound New Strategies to Prevent and Treat Opioid Addiction Optimizing Care for People with Opioid Use Disorder and Mental Health Conditions NIDA INSTITUTE FOR CLINICAL RESEARCH, INC. LEE, MARY (contact); LEGON, WYNN Washington, D.C 2023
NOFO Title: HEAL Initiative: Therapeutics Development for Opioid Use Disorder in Patients with Co-occurring Mental Disorders (UG3/UH3 - Clinical Trial Optional)
NOFO Number: RFA-DA-23-049
Summary:

Patients with opioid use disorder and co-occurring chronic pain and anxiety are at the highest risk for opioid overdose deaths. Low-intensity focused ultrasound (LIFU) is an innovative, noninvasive method that can be used to alter brain activity and potentially repair dysfunctional brain circuits involved in these disorders. This project will examine how LIFU directed to a small but critical brain region implicated in all three of these disorders, the anterior insula, can reduce drug craving, pain response, and anxiety symptoms as well as improve the physiological processes that may underlie the symptoms experienced by these patients.
1R21DA057598-01
Tracking the Opioid Epidemic with Social Media: An Early Warning System Cross-Cutting Research Leveraging Existing and Real-Time Opioid and Pain Management Data NIDA STANFORD UNIVERSITY ALTMAN, RUSS BIAGIO Redwood City, CA 2022
NOFO Title: HEAL Initiative: Exploratory Data and Methods to Address Urgent Needs to Stem the Opioid Epidemic (R21- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-22-045
Summary:

A key component to addressing the current opioid overdose crisis is the ability to track dangerous opioid use in a timely manner so that public health agencies can plan accordingly. Direct reports about drug use and overdoses from social media might provide a useful early warning system that when combined with other sources, can provide policy makers and public health officials with powerful tools for monitoring this public health crisis. This project will explore the usefulness of Twitter and Reddit as a social media component of opioid use surveillance – in particular by monitoring mentions of fentanyl and synthetic opioids at various geographic levels (e.g., local or regional) and over time.
1R01DA056658-01
Transcriptomic Single-Cell Profiling in Breathing-Specific Parabrachial Mu-Opioid Receptor Neurons Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA Salk Institute for Biological Sciences HAN, SUNG La Jolla, CA 2022
NOFO Title: HEAL Initiative: Novel Targets for Opioid Use Disorders and Opioid Overdose (R01 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-22-031
Summary:

Opioids can be effective analgesics but can also be fatal due to opioid-induced respiratory depression after overdose. This project will use cutting-edge molecular, physiological, behavioral, and imaging techniques to better understand and distinguish opioid-induced respiratory depression and opioid-mediated analgesia. Nerve cell-specific, single-cell transcriptomic analysis will be used to identify functional markers expressed in nerve cells that play a specific role in opioid-induced respiratory depression, but not opioid analgesia. This research study will help to identify novel therapeutic targets that could selectively rescue opioid-induced respiratory depression while maintaining the beneficial pain-relieving effects of opioids.