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 # | Project Title Sort ascending | Research Focus Area | Research Program | Administering IC | Institution(s) | Investigator(s) | Location(s) | Year Awarded |
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1R01DA045695-01A1
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Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings | Novel Therapeutic Options for Opioid Use Disorder and Overdose | Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose | NIDA | BOSTON UNIVERSITY MEDICAL CAMPUS | Stein, Michael D; Weisberg, Risa B | Boston, MA | 2019 |
NOFO Title: Behavioral & Integrative Treatment Development Program (R01 Clinical Trial Optional)
NOFO Number: PA-18-055 Summary: Often (around 40 percent of the time), individuals being treated for opioid use disorder (OUD) also have pain that interferes with daily life. This study builds on the prior development of a collaborative primary care approach, entitled TOPPS (Treating Opioid Patients’ Pain and Sadness), in which behavioral health specialists and primary care providers share a unified plan for addressing pain and depression in patients receiving buprenorphine. Building in preliminary work, researchers are conducting a randomized controlled trial of TOPPS compared to a health education contact-control condition among 250 persons with OUD recruited from two primary care-based buprenorphine programs, provided over 3 months and followed over 12 months. The study will examine whether this intervention changes how much pain interferes with daily functioning, the severity of pain, depression, and whether individuals stay in OUD treatment. |
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1UG1DA050072-01
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Transitions Clinic Network: Post Incarceration Addiction Treatment, Healthcare, and Social Support (TCN PATHS) study | Translation of Research to Practice for the Treatment of Opioid Addiction | Justice Community Opioid Innovation Network (JCOIN) | NIDA | YALE UNIVERSITY | WANG, EMILY AI-HUA | New Haven, CT | 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: Correctional settings have the potential to serve as key players in linking individuals with opioid use disorder (OUD) to treatment and health services upon release. Many individuals with OUD are being treated with medications, but these efforts will be ineffective if they fail to connect people to OUD treatment upon release. The Transitions Clinic Network (TCN) program provides enhanced primary care and OUD treatment for people recently released from incarceration. In TCN, formerly incarcerated community health workers are embedded within primary care teams and address social determinants of OUD, provide social support, help patients build trust in the health system, and advocate in interactions with the criminal justice system. This study will assess the effectiveness of the TCN: Post Incarceration Addiction Treatment, Healthcare, and Social Support (TCN PATHS) intervention versus referral to standard primary care on opioid treatment cascade outcomes and whether housing, food access, criminal justice contact, and social support mediate this association. |
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3UG1DA050072-02S2
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Transitions Clinic Network: Post Incarceration Addiction Treatment, Healthcare, and Social Support (TCN PATHS) study | New Strategies to Prevent and Treat Opioid Addiction | Sleep Dysfunction as a Core Feature of Opioid Use Disorder and Recovery | NIDA | YALE UNIVERSITY | Wang, Emily Ai-hua | New Haven, CT | 2020 |
NOFO Title: Notice of Special Interest (NOSI): NHLBI and NIDA Announce Availability of Administrative Supplements for HEAL Awardees to Address Sleep Impairments in OUD Treatment Response and Recovery Outcomes
NOFO Number: NOT-HL-20-746 Summary: All forms of sleep deficiency can affect OUD treatment engagement and retention among people with OUD, particularly among people recently released from jail. Sleep deficiency may lead to a wide range of physical and psychological perturbations that may increase the likelihood of illicit opioid use, and disengagement in OUD treatment. This study will examine the association between sleep deficiency and OUD treatment retention in a sample of people receiving medications for OUD who were recently released from jail, to reduce morbidity and mortality from OUD among justice-involved individuals. The underlying rationale for this study is that sleep deficiency must be addressed in a holistic manner to support OUD treatment engagement. The specific aims are to 1) determine the prevalence of sleep deficiency and describe the sleep environment of a sample of people on MOUD recently released from jail; 2) estimate the association between sleep deficiency and OUD treatment retention; and 3) examine sleep environment as a potential mediator of sleep deficiency and OUD treatment retention in people recently released from jail. If successful, this study will provide data for the future development and testing of patient-centered interventions focusing on sleep deficiency among OUD treatment participants that enhance their retention in treatment |
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1R44DA050339-01
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Transforming smartphones into active sonar systems to detect opioid overdose | Cross-Cutting Research | Small Business Programs | NIDA | SOUND LIFE SCIENCES, INC. | GILLESPY, THURMAN (contact); GOLLAKOTA, SHYAMNATH ; SUNSHINE, JACOB | Seattle, WA | 2019 |
NOFO Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
NOFO Number: RFA-DA-19-019 Summary: Deaths from opioid overdose are highly preventable with early detection and administration of naloxone, but overdose victims often die because they are alone or among untrained or impaired bystanders and thus do not receive timely resuscitation. There is an urgent, unmet need for a low-barrier, easily scalable solution that can identify opioid overdoses in real time and rapidly connect victims to naloxone therapy. This proposal seeks to commercialize an innovative overdose detection software product that can be downloaded on any commodity smartphone and can detect opioid- induced respiratory failure (i.e., overdose) and summon help. The software-only product, SecondChance, converts a smartphone into a short-range active sonar system capable of monitoring breathing and detecting overdose. |
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1U01DA057846-01
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Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine 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 | BJORK, JAMES M; ARIAS, ALBERT JOSEPH | Richmond, VA | 2022 |
NOFO Title: Grand Opportunity in Medications Development for Substance-Use Disorders (U01)
NOFO Number: PAR-19-327 Summary: Currently no medications are approved by the U.S. Food and Drug Administration to treat cocaine use disorder, which compromises cognitive function associated with achieving goals such as working memory, the ability to update information, and mental flexibility. This project will test whether stimulating dopamine activity in the brain with the drug rotigotine (approved to treat Parkinson’s disease) is effective for treating cocaine use disorder. Past research has also shown that rotigotine can improve nerve cell and cognitive function in Alzheimer’s disease. This project will conduct a clinical trial to test whether treatment with rotigotine combined with cognitive behavioral therapy can reduce cocaine use in people with cocaine use disorder. |
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1UG3DA058439-01
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Transcutaneous Phrenic Nerve Stimulation for Treating Opioid Overdose | Novel Therapeutic Options for Opioid Use Disorder and Overdose | Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose | NIDA | CORIDEA, LLC | LEVIN, HOWARD (contact); COMER, SANDRA D; GUEDES, ALONSO; WAGENER, GEBHARD | New York, NY | 2023 |
NOFO Title: Device-Based Treatments for Substance Use Disorders (UG3/UH3, Clinical Trial Optional)
NOFO Number: PAR-20-279 Summary: Difficulty breathing is a hallmark symptom of an opioid-related overdose and can result in permanent brain injury or death within minutes. This project will develop a community-deployable Automated External Respiration System device that can restore and sustain breathing in people experiencing opioid-induced respiratory depression. The device stimulates the phrenic nerve in the chest that controls breathing until other medical interventions are available or the patient recovers. The research will develop and validate the automated external respiration system for testing in human research participants and ultimately aims to develop a system usable in a community setting. |
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1R43DA050360-01
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Transcutaneous auricular neurostimulation for neonatal abstinence syndrome | Cross-Cutting Research | Small Business Programs | NIDA | SPARK BIOMEDICAL INC | KHODAPARAST, NAVID (contact); JENKINS, DOROTHEA DENISE | Friendswood, TX | 2019 |
NOFO Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
NOFO Number: RFA-DA-19-019 Summary: As of 2012, an infant with neonatal abstinence syndrome (NAS) was born every 25 minutes in the United States, accounting for more than $1.5 billion in national health care expenditures. These infants frequently require hospital stay in a neonatal intensive care unit (NICU), with an average hospital stay of 25 days at an average treatment cost of $66,000. Treatment of NAS usually follows a multimodal regime based on drug therapy with an oral morphine solution, mostly in combination with a sedative, but there is a need for nonpharmacological approaches. This project will test a transcutaneous auricular neurostimulation device to help NAS babies recover from opioid withdrawal without harmful side effects. The non-invasive, auricular neurostimulation device will be placed around the ear (similar to a hearing aid), and stimulation will be delivered transcutaneously. |
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1R01DA056658-01
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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. |
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1R21DA057598-01
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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. |
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1UG3DA059407-01
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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. |
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1UG1HD107628-01
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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. |
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1R61AT010614-01
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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. |
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1UF1MH121944-01
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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. |
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1R61DA059168-01
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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. |
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1R01DA057673-01
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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. |
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3R01DA042059-04S2
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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 |
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1R21NS130417-01
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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. |
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3UH3DA050251-03S1
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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. |
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3R61DA049382-02S2
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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. |
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1UG3DA048375-01
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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. |
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1R01DA059371-01
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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. |
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1U24DA055325-01
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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. |
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1UG3DA053094-01A1
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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. |
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1R34DA050286-01
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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. |
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1U01HL150596-01
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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. |