Funded Projects

Project # Project Title Sort descending Research Focus Area Research Program Administering IC(s) Institution(s) Investigator(s) Location(s) Year Awarded
1UG3DA050251-01
A digital intervention to prevent the initiation of opioid misuse in adolescents in school-based health centers New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA Yale University Fiellin, Lynn E. New Haven, CT 2019
FOA Title: HEAL Initiative: Preventing Opioid Use Disorder in Older Adolescents and Young Adults (ages 16–30) (UG3/UH3 Clinical Trial Required
FOA Number: RFA-DA-19-035
Summary:

Most opioid misuse begins during adolescence and young adulthood. Adolescence is the best time for prevention interventions in settings like school-based health centers (HCs), yet few programs focus on preventing initiation of opioid misuse. This study harnesses the power of video game interventions and incorporates components of effective substance use prevention programs to develop an evidence-informed intervention to prevent the initiation of opioid misuse in adolescents. In partnership with the national School-Based Health Alliance (SBHA), researchers will develop and test a new video game intervention, PlaySmart. It will build on our previous video game intervention that has demonstrated efficacy in improving attitudes and knowledge related to risk behaviors. The study will evaluate the game in a randomized controlled trial (RCT) in 10 school-based HCs and examine strategies for implementing PlaySmart in school-based HCs nationally. This research has considerable potential for wide implementation, reach, and impact on high-risk adolescents through school-based HCs.

1R43DA050349-01
A Novel Chemokine Receptor Antagonist to Block Opioid Reinforcement, Relapse and Physical Dependence New Strategies to Prevent and Treat Opioid Addiction Small Business Research and Development NIDA CREATIVE BIO-PEPTIDES, INC. RUFF, MICHAEL Potomac, MD 2019
FOA Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
FOA Number: RFA-DA-19-019
Summary:

Current agonist treatments for opioid use disorder (OUD) are not adequate to address the opioid crisis and have abuse liability concerns. Chemokines (hormones of the immune system that mediate innate immune inflammation) enhance pain, reduce opioid analgesia, and promote drug-seeking behavior and addiction—giving them a central role at the crossroads of chronic pain and the opioid crisis. So blocking chemokines (rather than opioid receptors) provides an exciting and untested treatment opportunity for pain and OUD. This proposal will assess, in animal self-administration models that mimic human drug-taking, whether a chemokine antagonist peptide R103 reduces morphine intake, as well as if R103 will prevent or blunt naloxone-precipitated withdrawal signs in morphine-dependent rats and stop relapse.

1R43DA047781-01
A NOVEL FAST ACTING NALMEFENE FORMULATION FOR THE PREVENTION AND TREATMENT OF OPIOID OVERDOSE New Strategies to Prevent and Treat Opioid Addiction Small Business Research and Development NIDA AVIOR, INC. Vasisht, Niraj Cary, NC 2019
FOA Title: PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
FOA Number: PA-18-574
Summary:

Rescue of victims of opioid overdose is accomplished by treatment with antagonist drugs, such as naloxone, that can reverse the respiratory depression. However, naloxone has serious liver toxicity and a short half-life, and its complete antagonism results in a withdrawal effect. Nalmefene is an FDA-approved opioid derivative that is an antagonist of the MOR and a weak agonist of the k-opioid receptors (KOR). An immediate release intravenous injectable formulation was approved by the FDA in 1995 for opioid overdose; however, the requirement for intravenous administration has limited its clinical use. This project, in partnership with Avior, aims to develop a fast-onset, rapidly-dissolving, mucoadhesive thin film formulation that carries uniformly distributed nalmefene nanoparticles on the surface of the film. This film, produced using Avior’s proprietary Speedit™ transmucosal drug delivery technology, rapidly delivers nalmefene when the film is placed in contact with the lower lining of the inner lip. This project will generate non-clinical data to support critical human clinical trials to determine if a transmucosal film can be developed with a rapid onset of action that is required for rescue of opioid overdose patients or taken prophylactically to prevent respiratory depression, to assess whether the effective speed of delivery is sufficient to conduct a human clinical trial.

1R44DA050375-01
A Novel Workflow to Screen for Illicit Drug Exposure in Newborns New Strategies to Prevent and Treat Opioid Addiction Small Business Research and Development NIDA BAEBIES, INC. KENNEDY, ADAM Durham, NC 2019
FOA Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
FOA Number: RFA-DA-19-019
Summary:

Rates of neonatal abstinence syndrome (NAS) have skyrocketed during the last decade, and estimates suggest that 5% of mothers use at least one addictive drug during their pregnancy. To address this public health crisis, multiple groups—including the American College of Obstetricians and Gynecologists and the American Academy of Pediatrics—recommend universal screening of substance use in pregnancy using standardized behavioral scoring tools. Unfortunately, such tools are often biased due to subjective scoring or self-reporting errors, and fail to identify babies who did not receive proper prenatal care. This project will develop a fast and accurate NAS screening tool that pairs a simple sample preparation protocol with a high-sensitivity panel of homogeneous enzyme immunoassays recognizing five common classes of drugs: fentanyl, morphine, amphetamine/methamphetamine, cocaine, and benzodiazepines. The potential benefits of such a system include reduced length of hospitalization for unaffected newborns, accelerated time to confirmatory results (under 2 hours), faster resolution of acute withdrawal symptoms, and improved referral to family/maternal support services.

1 R44 DA051272-01
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 Small Business Research and Development NIDA SURE MED COMPLIANCE HARTZEMA, ABRAHAM G Mobile, AL 2020
FOA Title: HEAL Initiative: America?s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
FOA 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

1R44DA046316-01A1
A Phase 1 Randomized Single Oral Dose Four Period Cross-Over Study Investigating Omnitram Dose Proportionality and Food Effect in Normal Human Subjects New Strategies to Prevent and Treat Opioid Addiction Small Business Research and Development NIDA SYNTRIX BIOSYSTEMS, INC. Kahn, Stuart J Auburn, WA 2019
FOA Title: PHS 2017-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44])
FOA Number: PA-17-302
Summary:

From 2009 to 2013, the utilization of the Schedule II opioids codeine, OxyContin, and fentanyl declined significantly, down about 14 percent for all three drugs. In sharp contrast, the use of tramadol, a Schedule IV controlled substance, increased by 32.5 percent. Schedule IV substances have lower potential for abuse and harm than Schedule II substances, and the fortuitous trend to tramadol has reduced the use of the relatively unsafe Schedule II opioids dramatically. However, tramadol is less effective in some individuals with a particular gene variant that makes them unable to metabolize it well. A new analgesic, omnitram, uses similar mechanisms to tramadol but is not as dependent on this gene. This SBIR Fast-Track project will conduct a Phase 1 clinical trial of Omnitram in normal human subjects. Success in this in-patient Phase 1 clinical trial will provide direct support for Omnitram’s continued clinical development toward FDA approval.

1R44DA049493-01
A Prescription Digital Therapeutic to Promote Adherence to Buprenorphine Pharmacotherapy for Patients with Opioid Use Disorder New Strategies to Prevent and Treat Opioid Addiction Small Business Research and Development NIDA PEAR THERAPEUTICS, INC. KERN, AUDREY; PALLONE, DAVINA Boston, MA 2019
FOA Title: Loyalty and Reward-Based Technologies to Increase Adherence to Substance Use Disorder Pharmacotherapies (R43/R44 - Clinical Trial Optional)
FOA Number: RFA-DA-19-014
Summary:

Opioid use disorder (OUD) is a key driver of the current opioid epidemic in the United States, but nearly 80% of individuals with OUD do not receive treatment. Buprenorphine medication-assisted treatment (MAT) is an effective form of care for OUD. This project will develop a state-of-the-art, digital therapeutic tool that effectively promotes buprenorphine adherence by providing contingency management rewards and educational content and enables home induction using a new self-monitoring support tool. This tool, named reSET-O+, will be integrated with Pear Therapeutics’ reSET-O, an FDA market-authorized mobile application delivering validated behavioral therapy and intended for use in conjunction with buprenorphine and standard outpatient treatment for OUD.

1R43DA050358-01
A Project to Test The Efficacy And Safety Of An Innovative Treatment Of Opiate Use Disorders New Strategies to Prevent and Treat Opioid Addiction Small Business Research and Development NIDA MINDLIGHT, LLC SCHIFFER, FREDRIC Newton, MA 2019
FOA Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
FOA Number: RFA-DA-19-019
Summary:

This project aims to demonstrate the safety and effectiveness of a novel treatment for opiate addiction using a technique called photobiomodulation, application of light to the forehead. The treatment consists of using a 4-minute application of transcranial photobiomodulation, near-infrared mode, through a supra-luminous LED, to one side of the forehead over the brain hemisphere that has been determined to have a more positive emotional valence. The study will examine differences in opioid cravings, anxiety, depression, and opioid use between participants receiving the treatment and those receiving a sham treatment. We will evaluate patients weekly for safety and efficacy for 3 weeks post-treatment. In Aim II, a highly-regarded product engineer will work with the company to design a marketable product that may have patentable elements.

3R01MH112138-03S3
A SYSTEM OF SAFETY (SOS): PREVENTING SUICIDE THROUGH HEALTHCARE SYSTEM TRANSFORMATION New Strategies to Prevent and Treat Opioid Addiction NIMH University of Massachusetts Medical School, Worcester BOUDREAUX, EDWIN D; KIEFE, CATARINA I. WORCESTER, MA 2018
FOA Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
FOA Number: PA-18-591
Summary:

The System of Safety (SOS) represents an opportunity to study the implementation of best practice suicide-related care processes that embody the Zero Suicide Essential Elements of Care across emergency departments, inpatient medical and behavioral health units, and primary care clinics associated with a large healthcare system. This effectiveness trial will use a stepped wedge design across a total of 39 clinical units. Aim 1 will measure suicide risk screening and screening's impact on risk identification. Aim 2 will measure the effective implementation of clinician-administered interventions, such as safety planning with means restriction counseling, on suicide, suicide attempts, and suicide-related acute healthcare. Exploratory aims will examine mechanisms of action, moderators, economics, and population effects of the intervention. This study's innovative approach positions it for a significant impact on the fields of suicide prevention, CQI, and effectiveness trial design and analysis.

1R43DA050338-01
A universal approach for improving the limit of detection for fentanyl and fentanyl derivatives in urine New Strategies to Prevent and Treat Opioid Addiction Small Business Research and Development NIDA CERES NANOSCIENCES, LLLP LEPENE, BENJAMIN SCOTT MANASSAS, VA 2019
FOA Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
FOA Number: RFA-DA-19-019
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
FOA 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)
FOA Number: PAR-18-701
1R44DA049631-01
Addressing Opioid Use Disorder with an External Multimodal Neuromodulation Device: Development and Clinical Evaluation of DuoTherm for Opioid-Sparing in Acute and Chronic Low Back Pain. New Strategies to Prevent and Treat Opioid Addiction Small Business Research and Development NIDA MMJ LABS, LLC BAXTER, AMY LYNN Atlanta, GA 2019
FOA Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
FOA Number: RFA-DA-19-019
Summary:

Acute and chronic low back pain are among the most common sources of short- and long-term disability. Fear of pain and disability, or “catastrophizing,” increases opioid use, but is reduced when patients have effective options and feel control over pain. The goal of this project is to develop an opioid-sparing therapeutic consumer device for low back pain, with multiple patient-controlled effective neuromodulatory pain relief options, including vibration, pressure, cold, and heat. After proving that providing a multimodal device is effective for pain, the project will determine whether the availability of an effective home therapy device reduces opioid use for patients with acute and chronic low back pain.

1R44DA050357-01
An optimized screening platform for identifying and quantifying biased agonists as drugs for the treatment of Opioid Use Disorder New Strategies to Prevent and Treat Opioid Addiction Small Business Research and Development NIDA MONTANA MOLECULAR, LLC QUINN, ANNE MARIE Bozeman, MT 2019
FOA Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
FOA Number: RFA-DA-19-019
Summary:

As the opioid crisis claims more and more lives, there is a need to develop new, safer analgesics. Biased agonists could activate beneficial signaling pathways while avoiding those that cause adverse effects. This project aims to speed the discovery of non-addictive analgesics by providing drug discovery teams with simpler, more robust, more quantitative assays for agonist bias. The goal is to optimize and test new assays for agonist bias at NOP, D3 dopamine, CB1 cannabinoid, and OPRM1 opioid receptors, which couple to both the Gi and ?-arrestin signaling pathway, and create new tools to improve the analysis of structure/activity relationships that can be used in drug discovery and distribute to researchers who are developing new drugs for OUD.

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
FOA Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
FOA 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.

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 DeLecea, Luis; Chen, Xiaoke Stanford, CA 2019
FOA 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)
FOA 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.

1R43DA049617-01
At-Home Virtual Reality Guided Imagery Intervention for Chronic Pain New Strategies to Prevent and Treat Opioid Addiction Small Business Research and Development NIDA LIMBIX HEALTH, INC. LEWIS, BENJAMIN; RICHEIMER, STEVEN H Palo Alto, CA 2019
FOA Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
FOA Number: RFA-DA-19-019
Summary:

Chronic pain affects more than 100 million adults in the United States, resulting in disability, loss of work productivity, and overall reductions in health, making chronic pain a major public health problem with an economic burden estimated at $560–635 billion annually. Opioids, the most frequently prescribed class of drugs to control pain, lack evidence supporting their long-term efficacy and carry a 15% to 26% risk of misuse and abuse among pain patients. Guided imagery (GI) is an effective non-pharmacological intervention for reducing pain, but its effectiveness is limited by patients’ imaging abilities. This project will develop and assess the feasibility of an at-home virtual reality system, Limbix VR Kit, to reduce chronic pain and opioid reliance, as well as improve other functional outcomes, by delivering an immersive GI experience.

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
FOA 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
FOA 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

1R41DA048689-01
BEST-OUD: Behavioral Economic Screening Tool of Opioid Use Disorder for use in clinical practice New Strategies to Prevent and Treat Opioid Addiction Small Business Research and Development NIDA BEAM DIAGNOSTICS, INC SNIDER, SARAH EMILY Roanoke, VA 2019
FOA Title: PHS 2018-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)
FOA Number: PA-18-575
Summary:

A critical line of defense against opioid use disorder (OUD), one of the nation’s leading preventable causes of death, must be standardized screening provided by the patient’s primary care physician, psychiatrist, and/or counselor. Standardized screening methods for opioids, however, are simply inferior and no gold standards exist. This project aims to develop a validated, theoretically guided tool that provides clinicians with information beyond OUD symptoms using reinforcer pathology, a measure of severity derived from the synergy between excessive delay discounting and high behavioral economic demand. The Behavioral Economic Screening Tool (BEST-OUD) will use these combined measures in a mobile tablet application to enable clinicians to screen for OUD.

3R01DA045396-02S1
Brief Individual and Parent Interventions for Marijuana Misuse in Truant Adolescents New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA Brown University SPIRITO, ANTHONY Providence, RI 2019
FOA Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
FOA Number: PA-18-591
Summary:

Four out of five youth in the juvenile justice (JJ) system show evidence of being under the influence during their offenses, and more than half test positive for substances at the time of their arrest. Preventive intervention approaches that can be easily implemented within JJ settings may offer greater access to substance use care as well as increase families’ motivation to comply with court referrals to seek further services. It is especially important to evaluate interventions for court-involved, non-incarcerated (CINI) juveniles, as these youth account for two-thirds of those arrested; however, the bulk of extant research has been conducted with detained or incarcerated youth. In this application for supplemental funding, we capitalize on our parent grant (Brief Individual and Parent Interventions for Marijuana Misuse in Truant Adolescents) by proposing to develop an adjunctive, targeted preventive intervention for marijuana-using, JJ youth who are at elevated risk for illicit opioid use. The goal will be to develop a protocol for a single-session, parent-adolescent preventive intervention to decrease the likelihood of illicit opioid use in CINI adolescents. This formative work will culminate in a draft intervention manual.

3U19MH121738-02S2
Buprenorphine Effect on Suicidal Behavior New Strategies to Prevent and Treat Opioid Addiction Optimizing Care for People with Opioid Use Disorder and Mental Health Conditions NIMH KAISER FOUNDATION RESEARCH INSTITUTE SIMON, GREGORY E Oakland, CA 2020
FOA 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
FOA Number: NOT-MH-20-025
Summary:

Mortality and morbidity related to suicidal behavior and opioid use disorder (OUD) have increased significantly over the past decade. These two public health crises are intertwined at multiple levels. Medications for OUD, especially buprenorphine, have been shown to decrease opioid use and reduce the multiple negative consequences of OUD, including fatal and nonfatal overdose, criminal justice involvement, infectious complications, and misuse of other substances. In addition, small randomized trials of buprenorphine treatment in treatment-resistant depression (with or without co-occurring OUD) suggest that buprenorphine reduces depressive symptoms and suicidal ideation. This large study will evaluate the effects of starting buprenorphine treatment on self-harm and suicide attempt among people with opioid use disorder, including those with and without co-occurring mental health conditions or other known risk factors for suicidal behavior. Comprehensive health records data from four large health systems serving a combined member/patient population of approximately 11 million will be examined for the overall effect of buprenorphine treatment on subsequent self-harm or suicide attempt, including differences in effects between patient subgroups and specificity of effects to buprenorphine vs other medications.

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 University of Pittsburgh Logan, Ryan W Pittsburgh, PA 2019
FOA 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)
FOA 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.

3U54EB020404-05S1
CENTER OF EXCELLENCE FOR MOBILE SENSOR DATA-TO-KNOWLEDGE (MD2K) - OVERALL New Strategies to Prevent and Treat Opioid Addiction NIBIB University of Memphis KUMAR, SANTOSH MEMPHIS, TN 2018
FOA Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
FOA Number: PA-18-591
Summary:

Rapid technological advances are leading to field-deployable mobile sensing devices that can quantify complex dynamics of key physical, biological, behavioral, social, and environmental factors, enabling us to understand causation in complex disorders. Significant new investment is needed to develop and disseminate data analytics tools. The Center of Excellence for Mobile Sensor Data-to-Knowledge (MD2K) will generate generalizable theory, methods, tools, and software to address major barriers to processing complex mobile sensor data and its use in biomedical knowledge discovery and just-in-time care delivery. We will develop and implement a standards-based, interoperable, extensible, and open-source big data software platform for efficient implementation of MD2K data analytics. MD2K will demonstrate the feasibility, utility, and generalizability of this approach by implementing the entire MD2K data analytics system in the context of two biomedical applications: reducing relapse among abstinent daily smokers and reducing readmission among congestive heart failure patients

3P50DA046351-02S1
Center to Advance Research Excellence (OPTIC) New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA RAND Corporation STEIN, BRADLEY Santa Monica, CA 2019
FOA Title: NIDA Research Center of Excellence Grant Program (P50)
FOA Number: PAR-16-009
Summary:

The U.S. is in the midst of an opioid crisis, and efforts to tackle the complex and dynamic nature of this public health challenge must comprehensively consider a multitude of contributing factors. In response, states have implemented a wide range of policies and initiatives. However, the dynamic nature of the crisis and the speed with which different policy approaches are being implemented pose numerous challenges for researchers evaluating the effects of such efforts. These challenges stem in part from limited information regarding policy implementation; insufficient information about policy characteristics that may influence effectiveness; little consideration of how the chosen analytic method may influence findings, given simultaneous or concurrent implementation of multiple policies; and limited training on how to best communicate findings to policymakers. To address these challenges, the proposed Center for Opioid Policy Research (COPR) will serve as a national resource, fostering innovative and high-quality research in the opioid policy arena and developing and disseminating methods, tools and information to the research community, policymakers and the public.

3R44DA044083-03S1
CLINICAL DATA INTELLIGENCE & ADVANCED ANALYTICS TO REDUCE DRUG DIVERSION ACROSS THE CARE DELIVERY CYCLE AND DRUG SUPPLY CHAIN IN HEALTH SYSTEMS New Strategies to Prevent and Treat Opioid Addiction Small Business Research and Development NIDA Invistics Corporation Knight, Thomas Peachtree Corners, GA 2019
FOA Title: PHS 2016-02 Omnibus Solicitation of the NIH, CDC, FDA, and ACF for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44])
FOA Number: PA-16-302
Summary:

There are alarming rates of substance abuse and diversion in hospitals, with multiple studies finding that roughly 10% of our nation’s nurses, anesthesiologists, and pharmacists are currently diverting drugs in their workplaces. Diversion continues even though most hospitals already lock addictive drugs in Automated Dispensing Machines (ADMs) and run monthly “anomalous usage” computer reports to try to detect diversion. This SBIR project will research mechanisms to detect when health care workers (HCWs) in hospitals steal or “divert” legal drugs, either to abuse themselves or to illegally sell to others, by building a computer system with (a) automated data feeds from multiple existing hospital computer systems and (b) advanced analytics to flag potential diversion for investigation. This research has the potential to reduce injuries to HCWs who are becoming addicted, destroying their careers, jeopardizing their patients’ safety, and increasingly dying from drug diversion overdoses.

1UF1MH121942-01
Collaborating to Heal Addiction and Mental Health in Primary care (CHAMP) New Strategies to Prevent and Treat Opioid Addiction Optimizing Care for People with Opioid Use Disorder and Mental Health Conditions NIMH UNIVERSITY OF WASHINGTON FORTNEY, JOHN C.; RATZLIFF, ANNA; SAXON, ANDREW J. Seattle, WA 2019
FOA Title: HEAL Initiative: Effectiveness Trials to Optimize, Implement, Scale, and Sustain the Collaborative Care Model for Individuals with Opioid Use Disorders and Mental Health Conditions (U01 Clinical Trial Required)
FOA Number: RFA-MH-19-525
Summary:

Medication-assisted treatment (MAT) represents the gold-standard intervention for opioid use disorder (OUD). However, only 20% of Americans with OUD received any formal or informal addiction treatment in the past year. Lack of access and engagement in MAT is driving poor OUD outcomes, especially in rural areas lacking specialty addiction services. The Advancing Integrated Mental Health Solutions (AIMS) Center at the University of Washington has successfully helped over a thousand primary care clinics across the country implement collaborative care for mental health disorders. The study will determine whether collaborative care can be used to successfully treat mental health disorders and OUD concurrently in primary care settings. Clinics offering collaborative care will randomize sites to add OUD to their collaborative care program or remain unchanged. Clinics not offering collaborative care will randomize sites to implementing collaborative care for OUD and mental health disorders simultaneously or for mental health disorders only.