Funded Projects

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

Project # Sort descending Project Title Research Focus Area Research Program Administering IC Institution(s) Investigator(s) Location(s) Year Awarded
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.

1R01DA057556-01 Disrupting Social Determinants of Health to Improve Substance Use and Mental Health Outcomes for Parents in Rural Regions New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA OREGON SOCIAL LEARNING CENTER, INC. SALDANA, LISA Eugene, OR 2022
NOFO Title: NIH HEAL Initiative: Preventing Opioid Misuse and Co-Occurring Conditions by Intervening on Social Determinants (R01 Clinical Trials Optional)
NOFO Number: RFA-DA-22-036
Summary:

Social determinants of health are individual and environmental factors that affect health, the ability to function, and quality of life. This project will study the impact of the family-focused Families Actively Improving Relationships (FAIR) prevention intervention currently offered in rural Oregon counties to parents experiencing substance use and mental health challenges. Through the FAIR program, participants receive substance use treatment services; mental health treatment services; parent management training; and support to access employment, housing, education or to mitigate exposure to violence and discrimination. This research will examine how the FAIR intervention affects substance use and societal determinants of health, toward informing payors and decision makers about the cost and value of FAIR prevention services in rural communities.

1R01DA059371-01 The Impact of Community Infrastructure Reinvestment Programs on Opioid Misuse and Opioid Overdose New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA UNIVERSITY OF PENNSYLVANIA NESOFF, ELIZABETH Philadelphia, PA 2023
NOFO Title: HEAL Initiative: Preventing Opioid Misuse and Co-Occurring Conditions by Intervening on Social Determinants (R01 - Clinical Trials Optional)
NOFO Number: RFA-DA-23-051
Summary:

Urban neighborhood deterioration (also known as blight) can affect individual and community health. Interventions have shown positive effects on neighborhood crime, gun violence, and mental health. In Philadelphia, government and community partnerships have remediated vacant lots and abandoned buildings to improve living conditions. This project will investigate the degree to which neighborhood improvement interventions in Philadelphia affect opioid misuse and overdose risk for residents. Results from this research could inform similar public health-based policy and community-level health interventions in other cities.

1R01DA059376-01 Social Safety Net Programs as Interventions to Reduce Opioid-Related Harms in Reproductive-Age Women New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA COLUMBIA UNIVERSITY HEALTH SCIENCES MARTINS, SILVIA SABOIA New York, NY 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:

Social safety net programs and Medicaid that provide basic necessities such as shelter, health care, and food to people with low incomes are particularly important for women parents who use drugs. This project will examine the separate and combined impact of state social safety net program eligibility and administration on opioid-related behavioral outcomes for women parents experiencing poverty. Findings from this research will provide actionable recommendations for changes to these programs that may promote health and well-being for these women.

1R01DA059401-01 Preventing School Exclusion and Opioid Misuse: Effectiveness of the Inclusive Skill-Building Learning Approach (ISLA) New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA UNIVERSITY OF OREGON NESE, RHONDA Eugene, OR 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:

Non-punishment, support-based preventive interventions in schools are needed to reduce misuse of opioids and other substances among youth. This project will test an intervention to improve school climate by introducing a learning approach that encourages behavior that is supportive and respectful in middle schools. ISLA reduces the use of exclusionary and discipline practices, such as suspensions and expulsions, that can be racially discriminating. The research aims to improve inclusive teaching practices, student engagement, student-teacher relationships, and school climate, while reducing student misuse of opioids and other substances.

1R01DA059411-01 Building Social and Structural Connections for the Prevention of OUD Among Youth Experiencing Homelessness: An RCT Examining Biopsychosocial Mechanisms New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA OHIO STATE UNIVERSITY FORD, JODI (contact); SLESNICK, NATASHA Columbus, OH 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:

Multiple social determinants affect the health of youth experiencing homelessness. These include a lack of stable safe housing, income, education, food security, restricted access to services, as well as discrimination, victimization, and social isolation. This project will test the use of prevention efforts to address the factors that may be embedded within systems that serve this population, such as drop-in centers. The research will gather generalizable information about helping these youth along with cost estimates to inform future implementation efforts.

1R01DA059465-01 The Impact of Central Sleep Apnea in Patients Receiving Medications for Opioid Use Disorder New Strategies to Prevent and Treat Opioid Addiction Sleep Dysfunction as a Core Feature of Opioid Use Disorder and Recovery NIDA UNIVERSITY OF PITTSBURGH PATEL, SANJAY R Pittsburgh, PA 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:

Medications used to treat opioid use disorder (OUD) such as methadone and buprenorphine can cause central sleep apnea—a condition in which an individual momentarily stops breathing during sleep. This project will evaluate whether central sleep apnea, by worsening sleep quality and causing low blood oxygen levels, leads to nighttime arousal and emotional distress, which in turn increases the risk of relapse in individuals receiving treatment for OUD.

1R01DA059469-01 Investigating Mechanisms Underpinning Outcomes in People on Opioid Agonist Treatment for OUD: Disentangling Sleep and Circadian Rhythm Influences on Craving and Emotion Regulation New Strategies to Prevent and Treat Opioid Addiction Sleep Dysfunction as a Core Feature of Opioid Use Disorder and Recovery NIDA EMMA PENDLETON BRADLEY HOSPITAL CARSKADON, MARY A (contact); MCGEARY, JOHN E; RICH, JOSIAH D Providence, RI 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:

Sleep and circadian rhythms are understudied risk factors for opioid use disorder (OUD) and its treatment. Opioids affect sleep quality in a way that can inhibit recovery. The two most effective medications for OUD also cause sleep problems. This project will increase understanding about underlying circadian and behavioral mechanisms, such as changes in craving and/or the ability to regulate emotions, that link poor sleep with suboptimal opioid treatment response outcomes.

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.

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.

1R01HL150432-01 Cell-type specific role of circadian-dependent transcription in fentanyl-induced synaptic and behavioral plasticity New Strategies to Prevent and Treat Opioid Addiction Sleep Dysfunction as a Core Feature of Opioid Use Disorder and Recovery NHLBI Boston University Logan, Ryan W Boston, MA 2019
NOFO Title: HEAL Initiative: Sleep and Circadian-Dependent Mechanisms Contributing to Opiate Use Disorder (OUD) and Response to Medication Assisted Treatment (MAT) (R01 - Clinical Trial Not Allowed)
NOFO Number: RFA-HL-19-028
Summary:

Among the most common symptoms experienced by individuals suffering with opioid use disorder (OUD) are severe sleep and circadian disruptions. The relationship between opioid dependence and sleep and circadian systems is not well understood. A circadian-dependent mechanism has been shown to modulate fentanyl reward-related behaviors in the nucleus accumbens (NAc). The study team will use a combination of behavioral, slice electrophysiology, and molecular approaches to 1) investigate the role of the circadian transcription factor NPAS2 in medium spiny neurons with dopamine 1 (D1R-MSNs); 2) assess the impact of fentanyl on synaptic plasticity at D1R-MSNs and investigate whether NPAS2 mediates the potentiation of excitatory synapses at specific diurnal phases; 3) elucidate the cell-type-specific NPAS2-dependent transcriptional mechanisms of fentanyl-seeking and relapse behaviors; and 4) investigate whether NPAS2 rescue and buprenorphine medication-assisted treatment (MAT) improve fentanyl-induced sleep disturbances. This study will define the role for circadian-dependent transcriptional mechanisms and uncover the therapeutic potential of NPAS2 for opioid dependence and relapse.

1R01HL150523-01 Deconstructing sleep disruption as a major risk factor for relapse in opioid use New Strategies to Prevent and Treat Opioid Addiction Sleep Dysfunction as a Core Feature of Opioid Use Disorder and Recovery NHLBI Medical College of Wisconsin EVERSON, CAROL A (contact); OLSEN, CHRISTOPHER M; RAFF, HERSHEL Milwaukee, WI 2019
NOFO Title: HEAL Initiative: Sleep and Circadian-Dependent Mechanisms Contributing to Opiate Use Disorder (OUD) and Response to Medication Assisted Treatment (MAT) (R01 - Clinical Trial Not Allowed)
NOFO Number: RFA-HL-19-028
Summary:

Profound sleep disturbances during abstinence have long been suspected of perpetuating vulnerability to relapse of people who misuse or are addicted to opioids. An animal model has shown that long-term sleep deficiency results in a persistent state of physiological dysregulation that is expected to modify the biology of abstinence and increase relapse potential. This study seeks to discover how persistent sleep restriction during withdrawal from opioid use increases vulnerability to relapse in the animal model by testing whether persistent sleep restriction during abstinence from opioid use is sufficient to increase opioid drug seeking. The functional outcome measure will be the degree of mitigation of opioid seeking. These studies will provide a basis for novel translational approaches to target mechanisms that are demonstrated to cause increased vulnerability to relapse.

1R01HL150566-01 Arousal circuitry and opiate-associated memories New Strategies to Prevent and Treat Opioid Addiction Sleep Dysfunction as a Core Feature of Opioid Use Disorder and Recovery NHLBI Stanford University DE LECEA, LUIS (contact); CHEN, XIAOKE Stanford, CA 2019
NOFO Title: HEAL Initiative: Sleep and Circadian-Dependent Mechanisms Contributing to Opiate Use Disorder (OUD) and Response to Medication Assisted Treatment (MAT) (R01 - Clinical Trial Not Allowed)
NOFO Number: RFA-HL-19-028
Summary:

Repetitive drug use forms powerful memories associating drug-evoked experiences with its proximal environmental cues. Memories are major obstacles for successfully treating addiction, since even after a prolonged period of abstinence, reexposure to such cues often triggers craving that promotes relapse. A polysynaptic pathway from the paraventricular nucleus of the thalamus (PVT) to the lateral hypothalamus (LH) has been shown to play a role in the maintenance of the opioid-associated memories. Hypocretin (Hcrt) neurons in the LH strongly innervate the PVT, required for maintaining wakefulness and involved in drug seeking. These factors may link sleep disorders in opioid addicts with their long-lasting drug-associated memories. This study will (1) determine whether Hcrt neurons in the LH are the major target; (2) examine whether manipulating the LH (Hcrt)-PVT pathway can effectively prevent relapse; and (3) test whether sleep intervention could be an effective strategy to prevent relapse.

1R01HL150836-01 Sleep, opiate withdrawal and the N/OFQ - NOP system New Strategies to Prevent and Treat Opioid Addiction Sleep Dysfunction as a Core Feature of Opioid Use Disorder and Recovery NHLBI SRI International KILDUFF, THOMAS S (contact); BRUCHAS, MICHAEL R Menlo Par, CA 2019
NOFO Title: HEAL Initiative: Sleep and Circadian-Dependent Mechanisms Contributing to Opiate Use Disorder (OUD) and Response to Medication Assisted Treatment (MAT) (R01 - Clinical Trial Not Allowed)
NOFO Number: RFA-HL-19-028
Summary:

The widespread misuse of opioids has underscored the need to develop nonaddicting pain medications. Chronic pain is a major factor contributing to insomnia, and sleep disruption due to chronic pain causes patients to seek relief, exacerbating the drive for prescription opioids. In opioid use disorder, withdrawal from opiates induces insomnia, posing an additional challenge for successful abstinence. This study aims to determine whether treatment of opioid withdrawal-induced insomnia with nociceptin/orphanin FQ receptor (NOPR) agonists will mitigate the drive for opiate use. A major component of the arousal/withdrawal circuitries resides in the locus coeruleus (LC), which expresses MOPRs. The study will determine whether and how the NOPR system engages LC circuits to reduce arousal and insomnia-related phenotypes and assess the hypotheses that 1) the NOPR system is a component of the endogenous sleep/wake regulatory system and 2) NOPR agonists can act as therapeutic interventions to reduce opiate use.

1R01MH128904-01 Supporting Treatment Access and Recovery for Co-Occurring Opioid Use and Mental Health Disorders (STAR-COD) New Strategies to Prevent and Treat Opioid Addiction Optimizing Care for People with Opioid Use Disorder and Mental Health Conditions NIMH University of Massachusetts Medical School SMELSON, DAVID A (contact); GONZALEZ, GERARDO ; LI, WENJUN ; OLMSTEAD, TODD ALDEN Worcester, MA 2021
NOFO Title: HEAL Initiative: Optimizing Multi-Component Service Delivery Interventions for People with Opioid Use Disorder, Co-Occurring Conditions, and/or Suicide Risk (R01 Clinical Trials Optional)
NOFO Number: RFA-MH-21-145
Summary:

Opioid use disproportionally affects people with co-occurring mental health disorders. Although medication for opioid use disorder (MOUD) is the gold standard of care, engagement rates are low. Also, it is unclear whether addition of one or more behavioral interventions improves outcomes of MOUD treatment, particularly in patients with co-occurring mental health disorders. This project evaluates the effectiveness of the “Maintaining Independence and Sobriety through Systems Integration, Outreach and Networking (MISSION)” intervention—a multi-component, cross-disciplinary, team-based treatment approach that combines three evidence-based practices with MOUD—in people with co-occurring mental health disorders. The 4-year, five-arm, randomized controlled clinical trial will determine the therapeutic benefit of adding MISSION to MOUD and identify the MISSION components that yield the largest clinical improvement and offer the greatest return on investment.

1R21AT009932-01 MINDFUL BODY AWARENESS TRAINING AS AN ADJUNCT TO MEDICATION ASSISTED TREATMENT FOR OPIOID USE DISORDER New Strategies to Prevent and Treat Opioid Addiction NCCIH University of Washington PRICE, CYNTHIA J; MERRILL, JOSEPH O SEATTLE, WA 2018
NOFO Title: Behavioral Interventions for Prevention of Opioid Use Disorder or Adjunct to Medication Assisted Treatment-SAMHSA Opioid STR Grants (R21/R33)
NOFO Number: RFA-AT-18-001
Summary:

This study leverages recent federal and state opioid use disorder treatment initiatives as a platform for testing a promising mind-body intervention, Mindful Awareness in Body-oriented Therapy (MABT) as an adjunct to MAT in two clinical settings funded through the Washington Opioid State Targeted Response (STR) program. MABT, a novel mindfulness-based intervention, uniquely addresses aspects of awareness, interoception, and regulation that may be associated with pain, mental health distress, and behavioral control that increase risk of relapse and poor treatment outcomes. Each setting employs a variation of the nationally recognized Massachusetts Nurse Care Manager model. Using a randomized, two-group, repeated measures design, we will compare those who receive MABT+MAT to MAT only. The overarching goal of this application is to test MABT to improve MAT health outcomes among patients receiving buprenorphine to treat OUD.

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.

1R21AT010109-01 MINDFULNESS ORIENTED RECOVERY ENHANCEMENT AS AN ADJUNCT TO METHADONE TREATMENT FOR OPIOID USE AND CHRONIC PAIN MANAGEMENT New Strategies to Prevent and Treat Opioid Addiction NCCIH Robert Wood Johnson Medical School COOPERMAN, NINA; KLINE, ANNA PISCATAWAY, NJ 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:

MAT is the most effective intervention for opioid use disorder (OUD), and methadone maintenance treatment (MMT) is the most commonly prescribed MAT; however, approximately half of people who begin MMT discontinue within a year, and half of people retained in MMT have an opioid relapse within six months. Chronic pain, affecting most people on MMT, could be contributing to relapse in this group. Novel behavioral interventions that address both chronic pain and opioid relapse among people on MAT are needed. Mindfulness Oriented Recovery Enhancement (MORE) was recently developed to treat both pain and opioid misuse. MORE is a group intervention that combines training in mindfulness, cognitive reappraisal, and positive emotion regulation skills to target the dysfunctional cognitive, affective, and behavioral pathways that lead to opioid use relapse. The objective of this proposal is to examine the impact of MORE on opioid relapse and chronic pain among individuals receiving MMT.

1R21AT010117-01 MINDFUL MOMS IN RECOVERY: YOGA-BASED MINDFULNESS RELAPSE PREVENTION FOR PREGNANT WOMEN WITH OPIOID DISORDER New Strategies to Prevent and Treat Opioid Addiction Behavioral Research to Improve Medication-Based Treatment NCCIH Dartmouth College LORD, SARAH E; GOODMAN, DAISY J Hanover, NH 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:

New Hampshire can anticipate as many as 1,000 infants born with prenatal opioid exposure each year. Pain management is complicated for pregnant women with opioid use disorder (OUD), and undermanagement of pain is a strong risk factor for relapse. Contemplative interventions, such as yoga and mindfulness, may reduce risks for relapse for pregnant and parenting women with OUD. This project represents a partnership with New Hampshire stakeholders to develop and pilot evaluation of a trauma-informed yoga and mindfulness relapse prevention intervention (Mindful Moms in Recovery: MMORE). It aims to: 1) identify needs and areas of adaptation of trauma-informed yoga and mindfulness-based relapse prevention protocols through formative work with pregnant and parenting woman; 2) develop an integrated 10-session intervention protocol with iterative feedback from client stakeholders; and 3) evaluate feasibility, acceptability, and efficacy trends of MMORE in a pre-post pilot with pregnant women.

1R21AT010118-01 COMPREHENSIVE CBT VIA RESET FOR A HUB AND SPOKE MAT SYSTEM OF CARE New Strategies to Prevent and Treat Opioid Addiction NCCIH Pennsylvania State University Hershey Medical Center KAWASAKI, SARAH SHARFSTEIN; NUNES, EDWARD V. Hershey, PA 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:

This study proposes to test the delivery of a comprehensive cognitive behavioral therapy, reSET, to determine whether it can improve treatment adherence and long-term outcome among patients with opioid use disorder initiating medication-assisted treatment within a community-based"Hub and Spoke” Model of buprenorphine maintenance in central Pennsylvania. reSET (Pear Therapeutics, Inc.) is a commercially available version of the web-based Therapeutic Education System (TES) delivered as a mobile app and recently approved by the FDA as the first digital therapeutic adjunct for the treatment of substance use disorders. Through a series of interactive therapy lessons, the program teaches patients cognitive-behavioral coping skills to resist drug use and to address factors such as craving, depression, and other mood problems and relationship issues that are associated with risk of relapse. The CM component provides concrete rewards contingent on performance of key target behaviors.

1R21DA049861-01 Impact of SB 273 on West Virginia Patients, Providers and Overall Prescription Rates of Opioid Medications New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA West Virginia University Cara Sedney; Treah Haggerty Morgantown, WV 2019
NOFO Title: Mechanism for Time-Sensitive Drug Abuse Research (R21 Clinical Trial Optional)
NOFO Number: PAR-19-064
Summary:

In 2018, new opiate prescribing limits (SB 273) were implemented across West Virginia to combat the opiate misuse epidemic. This study will utilize quantitative and qualitative measures to determine the effect of the recent opiate prescription laws in West Virginia, how a change in policy affects the opiate misuse epidemic, and how communities may apply this knowledge more broadly. The research team will: 1) collaborate with the West Virginia Board of Pharmacy to ascertain changes in opiate prescribing habits before and after the start of SB 273 using an interrupted time series methodology, and 2) achieve broad and deep understanding of how SB 273 has affected prescribing practices and experiences amongst primary care physicians, specialists (pan physicians, surgeons, emergency room physicians, etc.), and patients who currently or previously utilized opiate medications.

1R34DA050044-01 Improving health and employment outcomes through workplace opioid policies New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA Washington University Dale, Anne Marie St. Louis, MO 2019
NOFO Title: Pilot Health Services and Economic Research on the Treatment of Drug, Alcohol, and Tobacco Use Disorders (R34 Clinical Trial Optional)
NOFO Number: PA-18-774
Summary:

This study will develop and test the feasibility of implementing guidelines on workplace policies to reduce prescription opioid use, decrease chronic opioid use, promote recovery from opioid use disorder, and improve health-related employment outcomes. The researchers will develop and test these guidelines among construction workers. This project will provide critical information to design and conduct a randomized trial to implement and evaluate insurance and employment policy guidelines among labor-management health funds in the building trades. Aim 1 will identify current best-practice health care and employment policies to prevent health and employment consequences of opioid use. Aim 2 will characterize the opioid problem in construction and adapt best-practice healthcare and employment policies to the unique needs of the construction industry. Aim 3 will evaluate the feasibility of implementing workplace opioid guidelines in the construction trades and will define and collect measures of implementation and effectiveness.

1R43DA051279-01 Project Motivate: A digital motivation and prediction platform to improve treatment retention and reduce relapse in opioid use disorder New Strategies to Prevent and Treat Opioid Addiction NIDA BIOMOTIVATE, LLC GUTTMAN, JEREMY Pittsburgh, PA 2020
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:

One novel approach to address the opioid crisis is predicting the likelihood of retention in treatment for opioid use disorder (OUD) by assessing someone?s risk of early departure from treatment. Current methods rely on providers intuition to identify when an individual is at risk of leaving treatment early in order to intervene. This intervention, when it happens, often comes too late. Mobile health (mHealth) and Machine Learning (ML) predictive analytics offer a new opportunity to personalize OUD treatment, improve retention in OUD care, and mitigate the risk of relapse and overdose episodes. Project Motivate will combine physiological and behavioral data from disparate sources in order to predict when an individual is at risk of early departure from OUD treatment. If successful, results of the study will save lives, and lower medical costs, municipal emergency response costs, recidivism, workplace accidents, lost workplace productivity and costs to families.

1R44DA051272-01 A patient self-assessment software combining compliance protocols to improve prescriber confidence, reduce liability, and improve patient outcomes New Strategies to Prevent and Treat Opioid Addiction NIDA SURE MED COMPLIANCE HARTZEMA, ABRAHAM G Mobile, AL 2020
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:

The current overdose epidemic is being fueled by widespread, non-medical use of opioids prescribed by mostly well-meaning physicians who often lack adequate training on how to properly initiate, monitor, and discontinue opioid therapy. It is very difficult for physicians to fully assess a new patient?s risk of substance misuse and possible future overdose in the limited amount of time of a typical evaluation. The Care Continuity Program (CCP) is a novel, online patient self-assessment used by prescribers of opioids to better identify patient risk factors and therapy benefit. The CCP tool is completed by the patient, outside of the office, using an internet enabled device and follows a compliance-driven protocol. The results are instantly transmitted to the prescriber?s electronic health records (EHR), mitigating the prescriber?s civil and criminal liabilities. The study aims to validate the protocol and delivery system of the CCP by measuring patient outcomes, prescriber confidence, and completeness of documentation in the patient chart in primary care and pain management settings. If successful, this project can significantly expand the benefits of CCP to even a broader network of providers and help mitigate the impact of the opioid crisis

1U01DA059472-01 Value of Sleep Metrics in Predicting Opioid Use Disorder Treatment Outcomes: Leadership and Data Coordinating Center New Strategies to Prevent and Treat Opioid Addiction Sleep Dysfunction as a Core Feature of Opioid Use Disorder and Recovery NIDA HARVARD PILGRIM HEALTH CARE, INC. WANG, RUI (contact); PURCELL, SHAUN M; REDLINE, SUSAN S Canton, MA 2023
NOFO Title: HEAL Initiative - Sleep Predictors of Opioid-Use Disorder Treatment Outcomes Program: Leadership and Data Co-ordinating Center (U01 Clinical Trial Optional)
NOFO Number: RFA-DA-23-060
Summary:

Chronic opioid use has well-known effects on sleep quality and circadian rhythms, but few predictive metrics core to mental and physical health and well-being are available to guide treatment with medications for opioid use disorder (OUD). This project will identify observable characteristics related to sleep and circadian rhythms that predict OUD treatment outcomes, toward refining treatment strategies and developing new ones. This data coordinating center will ensure that (1) high quality and standardized data are collected across all research sites, (2) all milestones and regulatory requirements are met, (3) study results are reported in a timely manner, and (4) that data and results are disseminated broadly.