Funded Projects

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Project # Project Title Research Focus Area Research Program Administering IC Institution(s) Investigator(s) Location(s) Sort descending Year Awarded
3-UH3-DA050173-02
Optimized Interventions to Prevent Opioid Use Disorder among Adolescents and Young Adults in the Emergency Department New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA UNIVERSITY OF MICHIGAN AT ANN ARBOR WALTON, MAUREEN A 2021
NOFO Number:
Summary:

The emergency department (ED) is an ideal venue to reach and intervene with adolescents and young adults at risk for opioid misuse, particularly as young adults may disconnect from primary care when transitioning out of pediatric medicine. This study will evaluate the efficacy of interventions of varying type/intensity to prevent/reduce opioid misuse or opioid use disorder (OUD). The research leverages technology that is appealing to youth to facilitate intervention delivery by health coaches. In this study, adolescents and young adults in the ED screening positive for opioid use or misuse will be randomly assigned to one of four intervention conditions with outcomes measured at 4, 8, and 12 months. Technology-driven, scalable interventions delivered via health coach allow for real-time tailoring to the rapidly changing opioid epidemic, with the potential for a sustainable impact on preventing escalation of opioid misuse among adolescents and young adults. While we know that Black/African American youth are at increased risk for opioid and other substance use, they often do not participate in research studies. As a result, we do not know how well prevention interventions work with Black/African American individuals. This supplement will focus on increasing participant diversity and inclusion by recruiting additional Black/African American participants for this ongoing randomized controlled trial to study technology-driven prevention interventions.

3UH3DA050173-02S1
Optimized Interventions to Prevent Opioid Use Disorder among Adolescents and Young Adults in the Emergency Department New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA UNIVERSITY OF MICHIGAN AT ANN ARBOR WALTON, MAUREEN A Ann Arbor, MI 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 emergency department is an ideal venue to reach and intervene with adolescents and young adults at risk for opioid misuse, particularly as young adults may disconnect from primary care when transitioning out of care in pediatric settings. This study will evaluate the efficacy of interventions of varying type and intensity to prevent or reduce opioid misuse or opioid use disorder. The research leverages technology that is appealing to youth to facilitate intervention delivery by health coaches. In this study, adolescents and young adults in the emergency department screening positive for opioid use or misuse will be randomly assigned to one of four intervention conditions with outcomes measured at 4, 8, and 12 months. Technology-driven, scalable interventions delivered via health coaches allow for real-time tailoring to the rapidly changing opioid epidemic, with the potential to prevent an increase in opioid misuse among adolescents and young adults.  Black/African American youth are at increased risk for opioid and other substance use, but they often do not participate in research studies. As a result, it is not known how well prevention interventions work with Black/African American people. This supplement will focus on increasing participant diversity and inclusion by recruiting additional Black/African American participants for this ongoing randomized controlled study of technology-driven prevention interventions.

1UG3DA050173-01
Optimized Interventions to Prevent Opioid Use Disorder among Adolescents and Young Adults in the Emergency Department New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA Univ of Michigan at Ann Arbor WALTON, MAUREEN A (contact); BONAR, ERIN ELIZABETH Ann Arbor, MI 2019
NOFO Title: HEAL Initiative: Preventing Opioid Use Disorder in Older Adolescents and Young Adults (ages 16–30) (UG3/UH3 Clinical Trial Required
NOFO Number: RFA-DA-19-035
Summary:

The emergency department (ED) is an ideal venue to reach and intervene with adolescents and young adults (ages 16-30) at risk for opioid misuse, particularly as young adults may disconnect from primary care when transitioning out of pediatric medicine. This study will evaluate the efficacy of interventions of varying type/intensity to prevent/reduce opioid misuse or opioid use disorder (OUD). The research leverages technology that is appealing to youth to facilitate intervention delivery by health coaches. In this study, adolescents and young adults in the ED screening positive for opioid use or misuse will be randomly assigned to one of four intervention conditions with outcomes measured at 4, 8, and 12 months. Technology-driven, scalable interventions delivered via health coach allow for real-time tailoring to the rapidly changing opioid epidemic, with the potential for a sustainable impact on preventing escalation of opioid misuse among adolescents and young adults.

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.

3R01MH120124-02S2
Behavioral health Insurance coverage and outcome Risks of Co-occurring conditions among delivering women with opioid use and pain for HEAL: The BIRCH study New Strategies to Prevent and Treat Opioid Addiction Optimizing Care for People with Opioid Use Disorder and Mental Health Conditions NIMH UNIVERSITY OF MICHIGAN AT ANN ARBOR ZIVIN, KARA Ann Arbor, MI 2020
NOFO Title: Notice of Special Interest: HEAL Supplements to Improve the Treatment and Management of Common Co-occurring Conditions and Suicide Risk in People Affected by the Opioid Crisis
NOFO Number: NOT-MH-20-025
Summary:

Paralleling overall population trends, opioid use has escalated among pregnant and postpartum women, particularly among those with co-occurring perinatal mood and anxiety disorders, yet treatment remains underutilized. Since 2008, health insurance coverage changes led to a dramatic expansion of behavioral health coverage by increasing coverage and extending federal parity protections to more than 60 million Americans. Characterizing the clinical and economic impacts of these unprecedented extensions of behavioral coverage on maternal and infant outcomes among women with perinatal opioid use, chronic pain, and suicidality with and without co-occurring perinatal mood and anxiety disorders will inform future policy and targeted interventions

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
1R21AT010106-01
PSYCHOSOCIAL PAIN MANAGEMENT TO IMPROVE OPIOID USE DISORDER TREATMENT OUTCOMES New Strategies to Prevent and Treat Opioid Addiction Behavioral Research to Improve Medication-Based Treatment NCCIH University of Michigan, Ann Arbor ILGEN, MARK A. ANN ARBOR, MI 2018
NOFO Title: Clinical Trials or Observational Studies of Behavioral Interventions for Prevention of Opioid Use Disorder or Adjunct to Medication Assisted Treatment-SAMHSA Opioid STR Grants (R21/R33)
NOFO Number: RFA-AT-18-002
Summary:

Many individuals who receive medication-assisted therapy (MAT) leave treatment early and continue to struggle with opioid use disorder (OUD), often within the context of poorly managed comorbid chronic pain. Psychosocial interventions for pain have been effective in patients with chronic pain and substance use disorders, but these interventions have not been examined in the OUD population receiving MAT. This study proposes to refine and adapt a psychosocial pain management intervention (PPMI) delivered by telephone for patients with OUD receiving MAT and then to conduct a randomized controlled trial of the intervention in patients receiving MAT to improve adherence and pain- and substance-related outcomes. The intervention uses elements of cognitive behavioral pain management interventions adapted specifically for patients with OUD receiving MAT. The new intervention will be compared to an enhanced usual care condition (EUC) in 100 patients.

1K01DA044279-01A1
PREVENTING SUBSTANCE USE AMONG YOUTH: BEHAVIORAL AND ECONOMIC IMPACT OF ENHANCED IMPLEMENTATION STRATEGIES FOR COMMUNITIES New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA University of Michigan Ann Arbor EISMAN, ANDRIA B Ann Arbor, MI 2019
NOFO Title: Mentored Research Scientist Development Award (Parent K01)
NOFO Number: PA-16-190
Summary:

Quality implementation of evidence-based programs (EBPs) in community settings for youth is critical for reducing the burden of alcohol, tobacco and other drug (ATOD) use and its consequences. EBPs delivered in schools are an efficient way to reach large populations of young people, including those underserved by other settings, and reduce and prevent ATOD use. Yet youth rarely receive EBPs as intended in community settings, including schools. This training and research plan will prepare the investigator to become an independent scholar in the implementation of theories and frameworks to better understand factors related to program delivery—approaches to enhancing ATOD programs for youth in community settings. More specifically, the training will allow him to expand the application of Consolidated Framework for Implementation Research (CFIR) to inform approaches to enhancing effective EBP delivery. The proposed training and research plan extends current implementation research to focus applying implementation theories, frameworks and strategies in other community settings (schools) and on economic evaluation of implementation strategies. The results are expected to improve current efforts to deliver EBPs in diverse community settings and aid in applying evidence-based implementation strategies in the school context to ultimately reduce and prevent ATOD use among youth.

1UG3DA050234-01
Community Randomized Trial in the Cherokee Nation: CONNECT and CMCA for Preventing Drug Misuse among Older Adolescents New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA Emory University KOMRO, KELLI ANN (contact); LIVINGSTON, MELVIN D Atlanta, GA 2019
NOFO Title: HEAL Initiative: Preventing Opioid Use Disorder in Older Adolescents and Young Adults (ages 16–30) (UG3/UH3 Clinical Trial Required
NOFO Number: RFA-DA-19-035
Summary:

The national public health opioid crisis has disproportionately burdened rural white populations and American Indian populations. To address this crisis, the Cherokee Nation and Emory University public health scientists will carry out an opioid prevention trial to be conducted in at-risk rural communities in the Cherokee Nation (in northeast Oklahoma) with populations of white and American Indian adolescents and young adults. The study will expand and integrate two established intervention approaches, consisting of community organizing and universal school-based brief intervention and referral to further enhance their effects in preventing and reducing opioid misuse. These interventions, called CMCA and CONNECT, were originally designed to target adolescent alcohol use, but showed significant beneficial effects on use of other drugs, including prescription drug misuse. The expanded, integrated interventions will be tested in a community-randomized trial with the goal of new systems for sustained implementation within existing structures of the Cherokee Nation.

3U19MH113135-04S1
Social Connectedness and Behavioral Health Risks Among AI/AN Urban Adults New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIMH UNIVERSITY OF COLORADO DENVER MANSON, SPERO MARTIN Aurora, CO 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:

American Indian and Alaska Native (AI/AN) youth and young adults experience disproportionately high rates of suicide, mental health disorders, traumatic life events, and substance use disorder. More effective, culturally informed interventions are needed that are tailored to the specific needs of this population. This supplement will examine how a person?s social network contributes to their behavioral health (suicide risk, mental health, substance use) status and how this network can be leveraged to improve the uptake of prevention interventions. The long-term goal is to disseminate and translate the lessons learned into practical policy, organizational changes, and preventive innovations that optimize patient-centered health outcomes and ultimately reduce or eliminate the dramatic and tragic suicide-related health disparities among urban AI/AN YYAs.

3R37DA047926-02S1
Social networks of young American Indian adolescents and their parents:Characteristics, connections, and response to intervention New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA UNIVERSITY OF COLORADO DENVER WHITESELL, NANCY RUMBAUGH Aurora, CO 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
3U19MH113136-02S2
UNDERSTANDING THE INTERSECTION BETWEEN OPIOIDS AND SUICIDE THROUGH THE SOUTHWEST HUB New Strategies to Prevent and Treat Opioid Addiction NIMH Johns Hopkins University CWIK, MARY; BARLOW, MARY ALLISON 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:

The parent U19, “Southwest Hub for American Indian Youth Suicide Prevention,” builds capacity among local tribal governments, investigators, interventionists, and service providers across three Southwestern states to: 1) identify at-risk youth and gather robust local data through surveillance; 2) provide regular monitoring and brief interventions to close gaps in continuity of care; and 3) convene regularly for shared learning, policy development, and dissemination of best practices. The parent U19 includes an innovative SMART trial study design. The purpose of this supplement is to gather data on opioid use. Our supplement aims are to: 1) expand suicide surveillance in the Southwest Hub to include opioid use as a potential precipitant, facilitator, and risk factor for subsequent suicidal behavior; 2) explore community beliefs about correlates of risk, protective factors, and behavior functions of opioid abuse in Native American youth; and 3) examine opioid use among SMART trial participants.

1U01HL150568-01
Effects of experimental sleep disruption and fragmentation on cerebral Mu-opioid receptor function, Mu-opioid receptor agonist analgesia, and abuse liability. New Strategies to Prevent and Treat Opioid Addiction Sleep Dysfunction as a Core Feature of Opioid Use Disorder and Recovery NHLBI Johns Hopkins University Smith, Michael T Baltimore, MD 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:

Chronic pain and opioid use disorders (OUD) are burgeoning interrelated epidemics. Sleep disturbances are prevalent, treatable, and increasingly recognized as risk factors for both chronic pain and OUD. Sleep disruption impairs endogenous pain inhibition, linked to analgesic efficacy and rewarding properties of mu-opioid receptor (MOR) agonists. It is not known, however, whether sleep disturbance causally alters mechanisms that contribute to OUD risk. Sleep continuity disruption (SCD) and/or sleep fragmentation (SF) may alter cerebral MOR availability, and these forms of sleep disruption may increase OUD risk. This study aims to 1) evaluate whether experimental SCD and/or SF alter resting or pain-evoked MOR binding potential (BP) in brain regions associated with pain inhibition; 2) examine whether SCD and/or SF alters the analgesic response; and 3) determine whether MOR BP in brain regions of interest are associated with analgesia and abuse liability.

1U01HL150835-01
Evaluating the Role of the Orexin System in Circadian Rhythms of Sleep and Stress in Persons on Medication-Assisted Treatments for Opioid Use Disorder New Strategies to Prevent and Treat Opioid Addiction Sleep Dysfunction as a Core Feature of Opioid Use Disorder and Recovery NHLBI Johns Hopkins University HUHN, ANDREW S (contact); FINAN, PATRICK Baltimore, MD 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:

For individuals with moderate to severe opioid use disorder (OUD), medication-assisted treatments (MATs) such as oral methadone and extended-release naltrexone (XR-NTX) are the gold standard in initiating and maintaining long-term recovery. Still, many patients struggle with persistent sleep disturbance and stress reactivity in the early stages of recovery, which drive relapse behaviors. This proposal constitutes a novel mechanistic approach to understanding the role of the orexin system in sleep disturbance and circadian rhythms of stress in OUD patients who are maintained on MATs and are early in recovery. This study will determine whether the FDA-approved sleep medication suvorexant (SUVO) improves sleep continuity and decreases diurnal measures of stress, and whether improvement of sleep/stress processes translates to improved OUD treatment outcomes. Its findings will fill critical gaps in our understanding of the role of the orexin system in sleep disturbance and circadian rhythms of stress that impact OUD recovery.

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.

1R01DA059473-01
Sleep and Circadian Rhythm Phenotypes and Mechanisms Associated With Opioid Use Disorder Treatment Outcomes New Strategies to Prevent and Treat Opioid Addiction Sleep Dysfunction as a Core Feature of Opioid Use Disorder and Recovery NIDA JOHNS HOPKINS UNIVERSITY HUHN, ANDREW S (contact); RABINOWITZ, JILL ALEXANDRA Baltimore, MD 2023
NOFO Title: HEAL Initiative: Sleep Predictors of Opioid-Use Disorder Treatment Outcomes Program (R01 Clinical Trial Optional)
NOFO Number: RFA-DA-23-059
Summary:

Chronic opioid use has well known effects on sleep quality, including disordered breathing during sleep and other abnormalities related to circadian rhythms. However, little is known about the relationship between sleep-related symptoms and non-medical opioid use among individuals being treated for opioid use disorder. This longitudinal study aims to identify biological pathways that may account for these associations. The research will first determine associations of sleep and proxy measures of circadian rhythms with non-medical opioid use. Second, they will investigate emotional processes associated with sleep/circadian symptoms and opioid treatment outcomes.

3R01MH115840-02S1
Social Networks among Native American caregivers participating in an evidence-based and culturally informed intergenerational intervention New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIMH JOHNS HOPKINS UNIVERSITY BROCKIE, TERESA Baltimore, MD 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:

American Native (AN) communities experience high rates of trauma that compromise the mental health of parents and caregivers that in turn increases their children?s risk for suicide and substance use during adolescence and young adulthood. Without intervention, this intergenerational cycle may repeat. The goal of this study is to understand opioid use, suicide, and the social network characteristics of Fort Peck Assiniboine and Sioux parents and caregivers to determine how the social network of parents/adult caregivers are related to both risk for and protection from suicide and opioid use. This supplement will examine the effectiveness of a community health worker delivered, culturally tailored prevention intervention called Wa?Kan Ye?Zah on caregiver and child behavioral and mental health outcomes and assess the benefits of culturally enhancing the intervention for caregivers? well-being.

3S06GM123552-02S1
NATIVE TRANSFORMATIONS OPIATE PROJECT New Strategies to Prevent and Treat Opioid Addiction NIGMS Northwest Indian College RASMUS, STACY M; CALDWELL, SHEILA BELLINGHAM, WA 2018
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

Abuse of opioids constitutes a national public health crisis. Data from the Lummi Nation show that for the 18 Tribal member deaths occurring in the first seven months of 2016, five were opioid related, with the average age of the deceased being 29 years. The proposed Native Transformations Opioid Project (NTOP) seeks to develop research capacity at Northwest Indian College and its surrounding tribal communities to develop effective and culturally congruent strategies to reduce the burden of death from opioid and other drug-related overdoses in tribal communities in the Pacific Northwest. The primary aim of the proposed project is to identify the strengths and behavioral strategies in successful recovery from OUD in three Coast Salish communities. The ultimate goal of the proposed research is to identify Coast Salish recovery factors from OUD to develop a data-driven, culturally congruent intervention to reduce OUD and OUD overdose deaths.

3UG1DA015831-18S8
Optimizing Retention, Duration, and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy New Strategies to Prevent and Treat Opioid Addiction Optimizing the Duration, Retention, and Discontinuation of Medication Treatment for Opioid Use Disorder NIDA McLean Hospital Weiss, Roger Belmont, MA 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

This study will (1) test pharmacologic and behavioral strategies to improve OUD pharmacotherapy treatment retention and to improve outcomes among patients who have been successfully stabilized on OUD medications and want to stop medication and (2) identify predictors of successful outcome and develop a stage model of relapse risk.

3UG1DA015831-17S5
Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy New Strategies to Prevent and Treat Opioid Addiction Optimizing the Duration, Retention, and Discontinuation of Medication Treatment for Opioid Use Disorder NIDA McLean Hospital WEISS, ROGER D Belmont, MA 2019
NOFO Title: The National Drug Abuse Treatment Clinical Trials Network (UG1)
NOFO Number: RFA-DA-15-008
Summary:

This study will (1) test pharmacologic and behavioral strategies to improve OUD pharmacotherapy treatment retention and to improve outcomes among patients who have been successfully stabilized on OUD medications and want to stop medication and (2) identify predictors of successful outcome and develop a stage model of relapse risk.

3UG1DA015831-17S6
Subthreshold Opioid Use Disorder Prevention (STOP); which will test the efficacy of a primary care Subthreshold Opioid Use Disorder Prevention (STOP) New Strategies to Prevent and Treat Opioid Addiction Prevention of Progression to Moderate or Severe Opioid Use Disorder NIDA McLean Hospital WEISS, ROGER D Belmont, MA 2019
NOFO Title: The National Drug Abuse Treatment Clinical Trials Network (UG1)
NOFO Number: RFA-DA-15-008
Summary:

According to SAMHSA’s 2017 National Survey on Drug Use and Health (NSDUH), 11.4 million persons in the U.S. report past-year opioid misuse; out of them, only 2.1 million individuals met criteria for an OUD. Very little is known about efficacious interventions for those who do not meet criteria for moderate/severe OUD (i.e., subthreshold OUD). The prevalence of subthreshold OUD in primary care settings is 5 percent to 10 percent, with higher rates (21 percent to 29 percent) among those receiving prescribed opioids. Although they are at high risk of developing moderate/severe OUD and/or dying from an overdose, little or no empirical evidence exists for pragmatic prevention interventions that can be adopted at integrated general medical settings. To study the efficacy of prevention interventions to arrest the progression from risky opioid use, researchers will test the efficacy of a STOP intervention in primary care settings. STOP adopts an early intervention approach, based on a collaborative care model to prevent progression to moderate/severe OUD, and consists of a practice-embedded nurse care manager who provides patient education and supports the primary care provider (PCP) in engaging, monitoring and guiding patients who have risky opioid use; brief advice delivered to patients by their PCP; and phone counseling of patients by behavioral health providers to motivate and support behavior change. Researchers will determine whether STOP reduces risky opioid use and examine the impact of STOP on progression to moderate/severe OUD, overdose risk behavior and overdose events in adults with risky use of illicit or prescription opioids.

1R01DA059471-01
Medications for Opioid Use Disorder Differentially Modulate Intrinsically Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment New Strategies to Prevent and Treat Opioid Addiction Sleep Dysfunction as a Core Feature of Opioid Use Disorder and Recovery NIDA UNIVERSITY OF ALABAMA AT BIRMINGHAM CROPSEY, KAREN L (contact); GAMBLE, KAREN L Birmingham, AL 2023
NOFO Title: HEAL Initiative: Sleep Predictors of Opioid-Use Disorder Treatment Outcomes Program (R01 Clinical Trial Optional)
NOFO Number: RFA-DA-23-059
Summary:

People who use opioids, as well as those who take medications approved by the U.S. Food and Drug Administration for opioid use disorder (OUD), report significant problems with sleep and biological rhythms. This project will explore the activity of a novel group of photosensitive neurons in the retinas, a potential source for sleep disturbances in these individuals. The research could lead to new treatment strategies and responses, but also may identify a non-invasive, circadian biomarker to predict recovery and relapse in people with OUD.

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.

3R01DA046527-02S1
RESEARCHING EFFECTIVE STRATEGIES TO PREVENT OPIOID DEATH (RESPOND) New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA Boston Medical Center LINAS, BENJAMIN P Boston, MA 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
3K23DA045085-01S1
COLLABORATIVE CARE OFFICE-BASED OPIOID TREATMENT FOR ADOLESCENTS AND YOUNG ADULTS New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA Boston Medical Center HADLAND, SCOTT EVAN Boston, MA 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

Risk for opioid use disorder (OUD) often begins in adolescence and young adulthood. Engaging and retaining adolescents and young adults (collectively, “youth”) in early, effective treatment is critical for improving the life course trajectory of addiction. For adults with OUD, office-based opioid treatment (OBOT) with a collaborative care approach that includes behavioral therapy optimizes patient engagement and retention in care. Collaborative care OBOT is especially promising for youth, who can receive treatment from a trusted primary care provider in the same familiar setting they receive their usual medical care. To date, however, OBOT has not been formally adapted for treating youth. The central objective of this project is to develop and pilot an enhanced OBOT model for youth that is developmentally appropriate and family centered. The multidisciplinary nature of our team, which includes expertise in advanced biostatistical analysis, qualitative research, intervention development, developmental psychology, and implementation and improvement science, will maximize the chances of filling an important gap in the provision of youth specific evidence-based OUD interventions.