Funded Projects

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Project # Project Title Research Focus Area Research Program Administering IC Institution(s) Investigator(s) Location(s) Year Awarded
3R01DA044778-02S1 EXTENSION OF RISK FOR PRESCRIPTION OPIOID MISUSE IN ADOLESCENTS WITH THE FULL AGE SPECTRUM OF ADOLESCENCE THROUGH EMERGING ADULTHOOD New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA Oregon Health & Science University Feldstein Ewing, Sarah W.; Wilson, Anna Camille (contact) Portland, OR 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

Current rates of prescription opioid misuse are rising to epidemic levels among adults. These rates may be even higher among adolescents and young adults (AYAs), who have elevated levels of substance exploration and misuse during this precise developmental period. AYAs who are exposed to opioids via legitimate prescriptions by age 18 are at increased risk for misuse after high school. However, there is a substantial gap in our knowledge of what factors might contribute to the development of misuse and related poor outcomes in these high-risk youth. Identifying factors that convey risk for increasing opioid use and problematic use would inform AYA models of opioid abuse and inform the development of preventive interventions to modify risk in medical settings, which are a unique point of entry into opioid use, and a key setting in which to examine AYA outcomes. We will use a developmental model of the impact of opioid exposure by legitimate prescription during late adolescence, with consideration for pain and psychological characteristics of the individual within the psychosocial (family, peer, educational and work context). Determining mechanisms and moderators of risk during this developmental transition will provide critical information for the design of interventions aimed at reducing opioid use disorders in at-risk AYA.
3R01DA044745-01A1S1 FACILITATING SUSTAINMENT THROUGH IMPLEMENTATION FEEDBACK: THE SIC COACHING MODEL New Strategies to Prevent and Treat Opioid Addiction NIDA Oregon Social Learning Center, Inc. SALDANA, LISA Eugene, OR 2018
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

This proposal aims to test the impact of an empirically derived implementation strategy—under real-world conditions and across multiple child service systems—on successful adoption and sustainment of two evidence-based programs that address adolescent substance abuse: Treatment Foster Care Oregon (TFCO; formerly Multidimensional Treatment Foster Care) and Multidimensional Family Therapy (MDFT). The overarching goal of this proposal is to evaluate whether the integration of implementation fidelity (fidelity to the implementation process) with intervention fidelity (fidelity to the clinical intervention) can increase the probability that a new organizational site not only successfully adopts a program but develops the infrastructure to ensure it can sustain. This study will (a) evaluate the effect of stages of implementation completion coaching strategy (SIC-CS) on outcomes of program adoption and sustainment, (b) extend the SIC to include measurement of sustainment, and (c) examine cost and resource patterns most likely to yield sustainable programs.
3R01DA044522-16S1 PROXIMAL AND DISTAL PATHWAYS TO YOUNG ADULT OPIOID MISUSE New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA University of Washington OESTERLE, SABRINA Seattle, WA 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
3R01DA044184-02S1 DEVELOPMENT & MALLEABILITY FROM CHILDHOOD TO ADULTHOOD New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA Johns Hopkins University IALONGO, NICHOLAS S Baltimore, MD 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

The Family School Partnership (FSP) and classroom-centered (CC) interventions targeted aggressive-coercive behavior and poor academic achievement as antecedents of the distal outcomes of antisocial behavior, substance abuse/dependence, psychiatric symptoms/disorders, high-risk sexual behavior and successful adaptation to the relevant developmental demands of the educational, work, romantic relationships and family (both family of procreation and origin/orientation) social fields/contexts. The participants of the FSP and CC original prevention trial were a population (n = 798) of urban, predominately African-American young adults, who began first grade in the fall of 1993 in nine elementary schools in predominantly low- to lower-middle-income Baltimore areas. The central purpose of the proposed study is to extend through ages 31-35 an examination of normal and pathogenic development and the impact of these two universal first-grade preventive interventions on the distal targets mentioned above. We will continue to study the role of phenotypic and genetic factors (and their interactions) as well as the impact of the interventions on the development and course of substance use/abuse/dependence, psychiatric symptoms/disorders, antisocial behavior/disorder and high-risk sexual behavior through young adulthood. The knowledge accrued over the course of the proposed assessments should serve to inform the nature, targets and timing of our future preventive intervention efforts.
3R01DA044015-02S1 SUPPLEMENTAL APPLICATION FOR CLINICAL AND GENETIC RISK PROFILE OF OPIOID USE DISORDER New Strategies to Prevent and Treat Opioid Addiction NIDA Geisinger Clinic TROIANI, VANESSA; BERRETTINI, WADE H; ROBISHAW, JANET D DANVILLE, PA 2018
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

This project is focused on identifying the clinical, genetic, and neural characteristics that convey risk for prescription opioid addiction. We will leverage the central biorepository and electronic health record (EHR) database of the Geisinger Health System to conduct large-scale genomics research and phenotype development. Through a collaboration with Regeneron Pharmaceuticals, the Geisinger biobank currently contains DNA samples on about 110,000 participants and includes both Illumina OmniExpressExome genotyping and whole exome sequence data, including common and rare variants, from over 60,000 of these subjects. This discovery cohort contains thousands of chronic musculoskeletal pain patients who have been taking greater than 120 mg equivalents of morphine for more than three months. Using EHR and self-report tools to develop a case definition and quantitative scoring, we will derive a clinical/genetic profile of prescription opioid addiction. This profile will be enhanced via integration of neuroimaging data.
3R01DA043476-02S1 BUPRENORPHINE FOR PROBATIONERS AND PAROLEES: BRIDGING THE GAP INTO TREATMENT Translation of Research to Practice for the Treatment of Opioid Addiction Justice Community Opioid Innovation Network (JCOIN) NIDA FRIENDS RESEARCH INSTITUTE, INC. Gordon, Michael Scott Baltimore, MD 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

A large number of probationers/parolees with opioid use disorder have limited access to effective treatment. This study is the first random clinical trial in the United States that will assess the effectiveness of buprenorphine treatment using MedicaSafe, a system composed of secure pre-packaged buprenorphine/naloxone cartridges, designed to be dispensed by a SmartKey device that enables clinicians to track patient adherence. The study will initiate treatment at a community corrections office compared to referral to a community program. The public health impact of the proposed study would be widespread, as this model of care could be implemented throughout many areas of the United States with high rates of opioid use disorder in their probation/parolee populations that lack access to methadone treatment.
3R01DA043476-01A1S1 BUPRENORPHINE FOR PROBATIONERS AND PAROLEES: BRIDGING THE GAP INTO TREATMENT Translation of Research to Practice for the Treatment of Opioid Addiction Justice Community Opioid Innovation Network (JCOIN) NIDA FRIENDS RESEARCH INSTITUTE, INC. GORDON, MICHAEL SCOTT Baltimore, MD 2018
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

A large number of probationers/parolees with opioid use disorder have limited access to effective treatment. This study is the first random clinical trial in the United States that will assess the effectiveness of buprenorphine treatment using MedicaSafe, a system composed of secure pre-packaged buprenorphine/naloxone cartridges, designed to be dispensed by a SmartKey device that enables clinicians to track patient adherence. The study will initiate treatment at a community corrections office compared to referral to a community program. The public health impact of the proposed study would be widespread, as this model of care could be implemented throughout many areas of the United States with high rates of opioid use disorder in their probation/parolee populations that lack access to methadone treatment.
3R01DA043122-03S1 HEALTH AND JUSTICE: A CONTINUUM OF CARE FOR HIV AND SU FOR JUSTICE-INVOLVED YOUTH Translation of Research to Practice for the Treatment of Opioid Addiction NIDA NEW YORK STATE PSYCHIATRIC INSTITUTE ELKINGTON, KATHERINE S New York, NY 2018
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

Overcoming barriers to substance use (SU) screening and enrollment in SU care is central to decreasing justice-involved youth’s (JIY) negative HIV-related outcomes. This project proposes to embed HIV testing outreach workers from a youth-focused medical and HIV treatment program into an alternative sentencing program (ASP) to deliver a new service delivery model (Link2CARE) that integrates evidenced-based protocols for JIY to promote HIV and sexually transmitted infection (STI) testing and HIV and SU risk screening, and provide on-site intervention and cross-system linkage to HIV, STI, and SU care. We propose to determine the efficacy of Link2CARE delivered by health staff embedded within the ASP on HIV, STI, and SU outcomes; to determine the influence of theoretically based intervention mechanisms of change on the proposed HIV and SU outcomes; and to describe Link2CARE implementation and elucidate the system/organizational-, staff-, and youth-level factors that influence implementation of Link2CARE in an ASP.
3R01DA042859-02S1 OPIOIDS: PREVENTION OF IATROGENIC OPIOID DEPENDENCE AFTER SURGERY New Strategies to Prevent and Treat Opioid Addiction NIDA University of Michigan, Ann Arbor WALJEE, JENNIFER FILIP ANN ARBOR, MI 2018
NOFO Title: NIH Research Project Grant (Parent R01)
NOFO Number: PA-16-160
Summary:

Morbidity and mortality related to prescription opioids are accelerating in the United States. Identifying the factors that lead to new opioid dependence among opioid naïve patients is a critical opportunity to reduce prescription opioid dependence and unintended diversion. In the United States, the majority of individuals who become opioid dependent receive their first opioid prescription following surgical procedures, yet there are no clinical guidelines to inform appropriate postoperative opioid use. We will examine the patient factors that are associated with postoperative pain and opioid consumption among a cohort of patients undergoing common elective abdominal procedures. We will identify the provider characteristics in postoperative opioid prescribing practices, and design and implement a provider-directed intervention to optimize postoperative opioid prescribing. Findings will inform patients and providers regarding the risk of opioid dependence following surgery, and will establish a patient-centered data infrastructure that yields continuous feedback to providers regarding appropriate opioid prescribing practices.
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
3R01DA041434-03S1 IMPROVING ACCESS TO SUBSTANCE ABUSE EVIDENCE-BASED PRACTICES FOR YOUTH IN THE JUSTICE SYSTEM: STRATEGIES USED BY JPOS New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA Oregon Social Learning Center, Inc. SHEIDOW, ASHLI J Eugene, OR 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

Justice-involved young adults are one of the highest-risk populations for the development of opioid use disorder (OUD) and other significant public health problems, but they usually lack access to evidence-based practices that could potentially prevent this trajectory. The risk of unintentional death and other deleterious outcomes and long-term costs for opioid misuse for young adults, their communities and society (costs estimated at more than $115 billion annually) make this a priority, with rural areas in need of the most attention and assistance. The overriding purpose of the proposed pilot study is to prevent the onset of OUD by improving young adult offenders’ access to evidence-based risk reduction interventions, like contingency management (CM), by testing whether officers in the adult probation and parole setting can deliver such an intervention to their young adult substance using probationers who have not yet developed OUD. The primary motivation for this pilot is the clear public health need for improving and expanding delivery of substance use risk reduction interventions for young adults in the justice system. The ultimate outcome would be prevention of OUD in this high-risk population.
3R01DA037621-05S1 Long-term activation of spinal opioid analgesia after imflammation - Supplement Preclinical and Translational Research in Pain Management Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain NIDA University of Pittsburgh TAYLOR, BRADLEY K Pittsburgh, PA 2019
NOFO Title: Administrative Supplements for Validation of Novel Non-Addictive Pain Targets (Clinical Trials Not Allowed)
NOFO Number: NOT-NS-18-073
Summary:

Severe tissue injury generates central sensitization. Latent sensitization (LS) is a silent form of central sensitization that persists after tissue has healed and overt signs of hyperalgesia have resolved. Pain remission during LS is likely maintained by tonic opioid receptor activity. The opioid receptor inverse agonist, naloxone, can reinstate experimental pain when delivered one week after the resolution of secondary hyperalgesia following first degree thermal injury. Our aims are to test: 1) the hypothesis that burn or surgery triggers LS and long-term opioid analgesia in humans; 2) the hypothesis that mu-opioid receptor (MOR) constitutive activity (MORCA) receptors by opioid peptides maintains endogenous analgesia and restricts LS to a state of pain remission; 3) the extent to which MORs inhibit neural activity in the DH and synaptic strength in presynaptic terminals of primary afferent nociceptors during LS; and 4) whether MORs inhibit spinal NMDA receptor subunits to block pain during LS.
3R01DA001411-45S2 Monitoring the Future: Drug Use and Lifestyles of American Youth New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA University of Michigan at Ann Arbor Miech, Richard A. Ann Arbor, MI 2019
NOFO Title: Research Project Grant (Parent R01)
NOFO Number: PA-13-302
3R01AT010773-02S1 Minor Cannabinoids and Terpenes: Preclinical Evaluation as Analgesics Preclinical and Translational Research in Pain Management Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain NCCIH RESEARCH TRIANGLE INSTITUTE WILEY, JENNY L. Research Triangle Park, NC 2020
NOFO Title: Notice of Special Interest for HEAL Initiative: Request for Administrative Supplements to Existing Grants for Identification and Validation of New Pain and Opioid Use Disorder Targets within the Understudied Druggable Genome
NOFO Number: NOT-TR-20-008
Summary:

G-protein coupled receptor 3 (GPR3) is an orphan receptor present in the central nervous system (CNS) that plays important role in many normal physiological functions and is involved in a variety of pathological conditions. Although the brain chemical that activates this receptor has not been identified, work with GPR3 knockout mice has identified GPR3 as a novel drug target for several Central Nervous System (CNS) mediated diseases including neuropathic pain. However, despite the emerging behavioral implications of the GPR3 system, little is known about how GPR3 affects behavior due to the lack of potent and selective chemical probes that allow scientists to examine functioning of the receptor. Recently, two cannabinoid chemicals present in the cannabis plant were discovered as affecting GPR3. This study will modify the chemical structure of these compounds to increase their potency and selectivity so that they may be used as pharmacological tools to investigate the role of GPR3 in modulating pain. In addition, this project focuses on identifying new compounds that show promise for development into therapeutics for the treatment of pain.
3R01AT010757-02S1 The study of Gpr149 in nociception and the peripheral action of minor cannabinoids Preclinical and Translational Research in Pain Management Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain NCCIH UNIVERSITY OF CALIFORNIA, SAN FRANCISCO HELLMAN, JUDITH San Francisco, CA 2020
NOFO Title: Notice of Special Interest for HEAL Initiative: Request for Administrative Supplements to Existing Grants for Identification and Validation of New Pain and Opioid Use Disorder Targets within the Understudied Druggable Genome
NOFO Number: NOT-TR-20-008
Summary:

The cannabis plant contains many active compounds known collectively as cannabinoids that have been shown to possess analgesic and anti-inflammatory properties. These compounds exert their biological activity, in part, through the cannabinoid receptor. The cannabinoid receptor is a member of a class of proteins known as G-protein coupled receptors (GPCRs). This study will test whether a GPCR with unknown biological function, called Gpr149, has a role in the activity of cannabinoids. The study will identify and characterize Gpr149 expression in mouse cells, and deeply characterize the action of minor cannabinoids, endocannabinoids and products of inflammation to modulate Gpr149. This research will provide insight into the analgesic and anti-inflammatory action of minor cannabinoids and into the role of Gpr149 in nociception and the sensitization of nociceptors to inflammatory mediators.
3R01AT010742-01S1 Examining Trauma Prevalence and Exploring Interoception as a Mechanism of Emotion Regulation in MOUD Cross-Cutting Research Training the Next Generation of Researchers in HEAL NCCIH UNIVERSITY OF WASHINGTON PRICE, CYNTHIA J; MERRILL, JOSEPH O Seattle, WA 2022
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; PA-21-071
Summary:

Effective treatments for opioid use disorder need to address the complex needs of patients, which may include mental health problems and substantial chronic pain. This project will measure lifetime trauma experienced by men and women who take medication for opioid use disorder, as well analyze the association between types of trauma and symptomatic distress. The project will also explore whether an individual’s perceptions of sensations from inside their body (interoceptive awareness) affect emotional control and mental health. This research will fill knowledge gaps i critical to better understanding opioid use disorder treatment and relapse.
3R01AT008559-02S1 MECHANISMS OF PSYCHOSOCIAL TREATMENTS FOR CHRONIC LOW BACK PAIN New Strategies to Prevent and Treat Opioid Addiction NCCIH University of Washington JENSEN, MARK P; DAY, MELISSA ANNE SEATTLE, WA 2018
NOFO Title: NIH Research Project Grant (Parent R01)
NOFO Number: PA-16-160
Summary:

Chronic low back pain (CLBP) is a problem affecting millions of Americans. Psychosocial approaches are efficacious for addressing the multidimensional nature of CLBP. Three of the most widely implemented nonpharmacological techniques for CLBP management are cognitive therapy (CT), mindfulness meditation (MM), and behavioral activation (BA). However, there is a critical lack of research examining if these techniques work via the mechanisms specified by theory. Ecological momentary assessment (EMA) and ActiGraph technology embedded within a randomized controlled trial, consisting of daily measures of process and outcome, is ideal for testing mechanism models both during treatment and during the critical period following treatment. The current proposal seeks to utilize EMA and ActiGraph to examine if changes in cognitive content, cognitive process, and activity level are mechanisms specific to CT, MM, and BA, respectively, for reducing pain interference. Elucidating the mechanisms of pain coping skills will lead to streamlined CLBP interventions.
3R01AR069557-03S1 USE AND SAFETY OF OPIOIDS IN PATIENTS UNDERGOING TOTAL JOINT REPLACEMENT New Strategies to Prevent and Treat Opioid Addiction NIAMS Brigham And Women's Hospital KIM, SEOYOUNG CATHERINE Boston, MA 2018
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

Over 30% of adults aged 65 years and older in the United States suffer from osteoarthritis (OA). Opioid analgesics are often used for patients with moderate to severe symptomatic OA. When non-pharmacologic and pharmacologic treatments are not effective, patients with severe OA may undergo total joint replacement (TJR). Our primary objectives are to evaluate patterns of opioid use before and after TJR and to assess the effect of opioid use patterns on clinical outcomes and safety events in a large U.S. population–based cohort of OA patients. The specific aims are to: 1) identify predictors of persistent opioid use and opioid dose escalation in patients after TJR for hip or knee OA and 2) evaluate effects of opioid use patterns on short- and long-term clinical outcomes and safety following TJR. The results of this study will provide guidance on surgical risk stratification and pain management of patients before and after TJR.
3R01AR064251-07S1 Osteoarthritis Progression And Sensory Pathway Alterations Preclinical and Translational Research in Pain Management Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain NIAMS RUSH UNIVERSITY MEDICAL CENTER MALFAIT, ANNE-MARIE Chicago, IL 2020
NOFO Title: Notice of Special Interest for HEAL Initiative: Request for Administrative Supplements to Existing Grants for Identification and Validation of New Pain and Opioid Use Disorder Targets within the Understudied Druggable Genome
NOFO Number: NOT-TR-20-008
Summary:

There is an urgent need for new non-opioid therapeutic agents that treat the pain associated with Osteoarthritis (OA) ? a chronic, progressive disease that leads to pain in weightbearing joints, pain during movement, and pain at rest. This project will refine techniques for targeting several proteins expressed in sensory neurons associated with OA pain, with the goal of testing the potential of these proteins to serve as targets for development of effective, non-opioid painkillers.
3R01AA025848-03S1 AOD Use Trajectories from Age 10 to 24: Multi-level Predictors, Health and Behavioral Functioning, and Racial/ethnic Disparitie New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIAAA RAND Corporation D'Amico, Elizabeth J. Santa Monica, CA 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

There is a great deal of research aimed at better understanding transitions in alcohol and other drug (AOD) use patterns from early to late adolescence and from late adolescence to emerging adulthood. However, no studies to date have (a) assessments of AOD use from ages 10 to 24 across all developmental periods (middle school, high school, and emerging adulthood); (b) a large sample with substantial racial and ethnic diversity, particularly among Hispanic and Asian youth; (c) in-depth coverage of 10 areas of functioning across three key domains; (d) subjective and objective neighborhood data; or (e) the capacity to examine developmental trajectories for more than one substance. The current proposal is a continuation of previous projects that assessed AOD use across nine waves of data from age 10 to age 19. The proposed study capitalizes on the longitudinal data on protective and risk factors we have collected since age 10 in an ethnically diverse cohort by continuing to annually assess these youth in order to capture important transitions to emerging adulthood (through age 24). By advancing the epidemiology of alcohol use during adolescence and emerging adulthood, our findings can affect prevention and intervention programming for young people and address critical issues of public health policy.
3PL1HD101059-01S3 Administrative Supplement for ACT NOW OBOE Longitudinal Study Enhanced Outcomes for Infants and Children Exposed to Opioids Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) NICHD RESEARCH TRIANGLE INSTITUTE (NC) BANN, CARLA M Research Triangle Park, NC 2021
NOFO Title:
NOFO Number: PA-20-272
3PL1HD101059-01S2 Administrative Supplement to Increase Participant Diversity, Inclusion and Engagement in the ACT NOW OBOE Study Enhanced Outcomes for Infants and Children Exposed to Opioids Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) NICHD RESEARCH TRIANGLE INSTITUTE BANN, CARLA M Research Triangle Park, NC 2021
NOFO Title: HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Increase Participant Diversity, Inclusion and Engagement in Clinical Studies
NOFO Number: NOT-NS-21-025
Summary:

The ACT NOW Outcomes of Babies with Opioid Exposure (OBOE) Study – also called the ACT NOW Longitudinal Study – is a longitudinal cohort study to prospectively examine longitudinal outcomes from birth to 2 years of age among infants who were exposed to opioids in utero as compared to matched controls. The objectives of this study are to i) determine the impact of pre-birth opioid exposure on brain structure and connectivity over the first 2 years of life, ii) define medical, developmental, and behavioral outcomes over the first 2 years of life in infants exposed to opioids, and iii) Explore whether and how the home environment, maternal mental health, and parenting affect brain connectivity and neurodevelopment trajectories over the first 2 years of life. This research will use an innovative approach to engage a more diverse study population and thereby improve the generalizability of the research findings.
3PL1HD101059-01S1 Supplement to increase the sample size of the Outcomes of Babies with Opioid Exposure (OBOE) study cohort. Enhanced Outcomes for Infants and Children Exposed to Opioids Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) NICHD Research Triangle Institute Bann, Carla Research Triangle Park, NC 2020
NOFO Number: PA-18-591
Summary:

Neonatal opioid withdrawal syndrome (NOWS) has emerged as a tragic by-product of the opioid epidemic. Newborns whose mothers used opioids while pregnant can experience symptoms of opioid withdrawal in the days following birth, such as tremors, irritability, seizures, sleep, digestive, and feeding problems. However, little is known about the effect of antenatal opioid exposure on longer-term infant development over time. To address this gap in understanding, the ACT NOW Longitudinal study is examining a crucial developmental period from birth to two years of life through a comprehensive battery of assessments, including MRI imaging, neurodevelopmental behavioral assessments, and family report measures. This longitudinal cohort study is projected to include a total of 375 infants, 250 who were exposed to opioids and 125 matched controls.
3P50MH113662-01A1S1 Accelerator Strategies for States to Improve System Transformations Affecting Children Youth and Families New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIMH NYU School of Medicine Hoagwood, Kimberly; McKay, Mary New York, NY 2019
NOFO Title: Advanced Laboratories for Accelerating the Reach and Impact of Treatments for Youth and Adults with Mental Illness (ALACRITY) Research Centers (P50 Clinical Trial Optional)
NOFO Number: PAR-18-701
3P50DA048756-01S1 Prevention Research Center: Parenting among women who are opioid users New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA University of Oregon Fisher, Philip A.; Leve, Leslie Diane (Contact); Stormshak, Elizabeth A. Eugene, OR 2019
NOFO Title: NIDA Research Center of Excellence Grant Program (P50 Clinical Trial Optional)
NOFO Number: PAR-18-224