Funded Projects

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

Project # Project Title Research Focus Area Research Program Administering IC Institution(s) Investigator(s) Location(s) Sort ascending Year Awarded
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 (contact); RATZLIFF, ANNA ; SAXON, ANDREW J Seattle, WA 2019
NOFO Title: HEAL Initiative: Effectiveness Trials to Optimize, Implement, Scale, and Sustain the Collaborative Care Model for Individuals with Opioid Use Disorders and Mental Health Conditions (U01 Clinical Trial Required)
NOFO Number: RFA-MH-19-525
Summary:

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.

1R44DA050339-01
Transforming smartphones into active sonar systems to detect opioid overdose Cross-Cutting Research Small Business Programs NIDA SOUND LIFE SCIENCES, INC. GILLESPY, THURMAN (contact); GOLLAKOTA, SHYAMNATH ; SUNSHINE, JACOB Seattle, WA 2019
NOFO Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
NOFO Number: RFA-DA-19-019
Summary:

Deaths from opioid overdose are highly preventable with early detection and administration of naloxone, but overdose victims often die because they are alone or among untrained or impaired bystanders and thus do not receive timely resuscitation. There is an urgent, unmet need for a low-barrier, easily scalable solution that can identify opioid overdoses in real time and rapidly connect victims to naloxone therapy. This proposal seeks to commercialize an innovative overdose detection software product that can be downloaded on any commodity smartphone and can detect opioid- induced respiratory failure (i.e., overdose) and summon help. The software-only product, SecondChance, converts a smartphone into a short-range active sonar system capable of monitoring breathing and detecting overdose.

1R44DA049629-01
Connected Pharmacy Platform to Improve Adherence to Buprenorphine-Naloxone Prescription Treatment of Opioid Use Disorder Cross-Cutting Research Small Business Programs NIDA PILLSY INC. LEBRUN, JEFFREY (contact); MCPHERSON, STERLING M Seattle, WA 2019
NOFO Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
NOFO Number: RFA-DA-19-019
Summary:

Opioid agonist therapy (OAT), such as buprenorphine/naloxone (BUP/NAL), is proven effective against opioid use disorder (OUD), but poor medication adherence is a major barrier. This project aims to substantially increase adherence to oral BUP/NAL with Pillsy, a smart technology platform, which acts like a digital medication coach, providing education and reminders using a mobile app, text messages, and automated phone calls. The platform is built around a Bluetooth-based smart pill bottle cap that automatically tracks doses and timing, and sends intelligent reminders to create a unique feedback loop, which allows constant optimization of the incentive/reminder messages to meet user needs to increase adherence. A dashboard enables providers to easily track medication use and patient engagement. The Pillsy platform only nominally increases the cost of oral BUP/NAL treatment, and physicians can bill for monitoring time (CPT code 99091). The project team will adapt the current Pillsy platform and perform a randomized efficacy trial of BUP/NAL adherence.

1U01DK123786-01
Randomized ESRD Trial COmparing CBT alone VERsus with buprenorphine (RECOVER) Clinical Research in Pain Management Integrated Approach to Pain and Opioid Use in Hemodialysis Patients NIDDK UNIVERSITY OF WASHINGTON MEHROTRA, RAJNISH (contact); CUKOR, DANIEL ; UNRUH, MARK LYNN Seattle, WA 2019
NOFO Title: HEAL Initiative: Integrated Approach to Pain and Opioid Use in Hemodialysis Patients: The Hemodialysis Opioid Prescription Effort (HOPE) Consortium - Clinical Centers (U01 Clinical Trial Required)
NOFO Number: RFA-DK-18-030
Summary:

For patients with end-stage renal disease treated with long-term hemodialysis (HD), the safety and efficacy of behavioral interventions alone or augmented by safer drugs remain untested. This study will perform a multicenter parallel group randomized controlled trial to test the efficacy of two interventions to reduce opioid use in HD patients. Seven hundred and twenty HD patients with significant and ongoing opioid use will be randomly assigned to (1) telehealth cognitive behavioral therapy (CBT) alone, (2) telehealth CBT augmented by transdermal buprenorphine, and (3) usual care, with follow-up for up to one year. The primary outcome will be prescribed morphine milligram equivalent (MME) over the preceding four weeks. Three patient-reported outcomes (interference by pain, functional status, and quality of life) will comprise the secondary outcomes.

3R01DA044522-16S1
PROXIMAL AND DISTAL PATHWAYS TO YOUNG ADULT OPIOID MISUSE New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA University of Washington OESTERLE, SABRINA Seattle, WA 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
3U24NS115678-01S1
Increasing Diversity and Community Engagement in EPPIC-Net Research at the University of Washington Clinical Research in Pain Management Early Phase Pain Investigation Clinical Network (EPPIC-Net) NINDS UNIVERSITY OF WASHINGTON BACKONJA, MIROSLAV MISHA Seattle, WA 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:

A main goal of the NIH HEAL Initiative and the Early Phase Pain Intervention Clinical Network (EPPIC-Net) is to improve pain management by discovering and validating biomarkers and non-opioid pain medications. This award will leverage the resources at the University of Washington’s EPPIC-Net’s Specialized Clinical Centers by implementing and evaluating strategies to improve the engagement, recruitment, and retention of individuals from underserved racial/ethnic minority populations to participate in EPPIC-Net clinical trials. The site’s network spans multiple states and specialties, allowing access to geographically and demographically diverse patient populations, including underrepresented and underserved populations. 

4R33NS113315-02
Biomarker Signature to Predict the Persistence of Post-Traumatic Headache Clinical Research in Pain Management Discovery and Validation of Biomarkers, Endpoints, and Signatures for Pain Conditions NINDS MAYO CLINIC ARIZONA CHONG, CATHERINE DANIELA Scottsdale, AZ 2023
NOFO Title: Discovery of Biomarkers, Biomarker Signatures, and Endpoints for Pain (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-NS-18-041
1R61NS113315-01
Biomarker Signature to Predict the Persistence of Post-Traumatic Headache Preclinical and Translational Research in Pain Management Discovery and Validation of Biomarkers, Endpoints, and Signatures for Pain Conditions NINDS MAYO CLINIC ARIZONA CHONG, CATHERINE DANIELA Scottsdale, AZ 2019
NOFO Title: Discovery of Biomarkers, Biomarker Signatures, and Endpoints for Pain (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-NS-18-041
Summary:

There is currently no recognized way of accurately predicting who will recover from post-traumatic headache (PTH) during the acute phase following concussion and who will go on to develop persistent post-traumatic headache (PPTH), a condition that is difficult to treat effectively. Clinical experience suggests that early treatment is most effective, before headache patterns become persistent, but treating all patients with PTH would expose some patients to unnecessary treatment. Clinicians lack the information needed to make informed treatment decisions. Therefore, the study goals are to develop a prognostic biomarker signature for PPTH using clinical data and structural and functional brain neuroimaging and to assess the predictive accuracy of an ensemble biomarker signature for the early identification of patients at high risk for PPTH. This study can be translated into clinical practice and integrated into PTH clinical trials for early identification of those individuals who are at high risk for PPTH.

1R43DA049684-01
Non-intrusive detection of temporary neurologic impairment by opioids Cross-Cutting Research Small Business Programs NIDA ZXEREX CORPORATION BESSERMAN, RICHARD Scottsdale, AZ 2019
NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)
NOFO Number: PA-18-573
Summary:

With the exception of the Breathalyzer for alcohol, there is currently no available technology that can immediately identify neurologic impairment related to the use of licit or illicit drugs. The presently available methods for detecting opioids—which rely upon analysis of urine, blood, saliva, or hair—are expensive, time-consuming to implement, and can take days to deliver actionable information to meet the “fitness-for-duty” concerns of employers as well as the needs for immediate detection of drug use in the drug rehabilitation and public safety fields. This project intends to develop a non-invasive means of identifying temporary neurological impairment from prescription opioids using analysis of involuntary eye movements. The resultant biometric signature of opioid impairment will be incorporated into Zverex’s existing product library of oculomotor biosignatures, such as marijuana impairment and fatigue.

3R01MD010372-03S1
PROSPECTIVE STUDY OF RACIAL AND ETHNIC DISPARITIES IN CHRONIC PAIN AND PAIN BURDEN Clinical Research in Pain Management NIMHD Rand Corporation MARSHALL, GRANT Santa Monica, CA 2018
NOFO Title: Mechanisms, Models, Measurement, & Management in Pain Research (R01)
NOFO Number: PA-13-118
Summary:

Data suggest that members of minority groups are more likely to develop chronic pain and to have greater pain burden. We will identify a set of promising intervention targets for reducing or eliminating racial/ethnic pain disparities. We will interview adult survivors of serious physical injury, comprised of roughly equal proportions of African-Americans (AA), Latinos, and non-Latino Whites (NLW), and examine their medical records for information on injury severity and medication use in-hospital. Our aims are to determine whether: 1) AA and Latino physical injury survivors experience more severe pain relative to NLW; 2) AA and Latino injury survivors experience greater pain burden relative to NLW counterparts; 3) differences in pain severity burden are linked to a set of target candidates for interventions; and (4) pain outcomes in at-risk minority groups can be linked to a set of target candidates for group-tailored interventions to reduce pain severity and pain burden.

3UF1MH121954-01S1
Improving Access and Treatment for Co-occurring Opioid Use Disorders and Mental Illness New Strategies to Prevent and Treat Opioid Addiction Optimizing Care for People with Opioid Use Disorder and Mental Health Conditions NIMH RAND CORPORATION WATKINS, KATHERINE E (contact); KOMAROMY, MIRIAM Santa Monica, CA 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:

The United States is in the middle of two intertwined epidemics. Suicide and overdose deaths are at record levels. Opioid use disorder and mental illness are major contributors to both, with the highest death rates seen in people with co-occurring disorders (COD). This competitive revision tests whether enhancements to the collaborative care (CC) model adapted for co-occurring disorders improves retention in medication treatment and decreases suicide and overdose risk. The three additional components include: (1) education of family members about addiction and medication treatment; (2) training for family members to administer naloxone and on how to reduce opioid risk behaviors, and (3) implementation of Caring Contacts, a suicide prevention intervention. This study will examine patient and family member attitudes toward overdose education and naloxone in the population with COD; examine and then intervene with family members around patients? use of medication; and test in the COD population the effectiveness of universal suicide and overdose prevention programs.

3R34AA025480-02S1
IMPLEMENTING MEDICATION-ASSISTED THERAPY FOR SUBSTANCE USE DISORDERS IN MENTAL HEALTH New Strategies to Prevent and Treat Opioid Addiction Optimizing Care for People with Opioid Use Disorder and Mental Health Conditions NIAAA Rand Corporation WATKINS, KATHERINE E SANTA MONICA, CA 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

Substance use disorders (SUDs) can have devastating consequences for people with serious mental illness (SMI). SUDs can increase morbidity and mortality and are associated with higher healthcare and social costs, homelessness, and incarceration. Unfortunately, despite the availability of effective treatments, most individuals with co-occurring SMI and SUD (COD) never receive SUD treatment. We propose to evaluate system, provider, and patient-level facilitators and barriers and develop an implementation strategy and toolkit to promote the use of medication-assisted treatment (MAT) for people with COD. Aims 1–3 seek to assess organizational capacity (at the system and provider level); organizational readiness (at the provider level); and perceived needs, attitudes, and preferences (at the patient level) to identify barriers and facilitators. In Aim 4, we will use findings from Aims 1–3 to guide development of the implementation strategy and toolkit, using stakeholder input and a systematic process for strategy development.

1UF1MH121954-01
Improving Access and Treatment for Co-occurring Opioid Use Disorders and Mental Illness New Strategies to Prevent and Treat Opioid Addiction Optimizing Care for People with Opioid Use Disorder and Mental Health Conditions NIMH RAND CORPORATION WATKINS, KATHERINE E (contact); KOMAROMY, MIRIAM Santa Monica, CA 2019
NOFO Title: HEAL Initiative: Effectiveness Trials to Optimize, Implement, Scale, and Sustain the Collaborative Care Model for Individuals with Opioid Use Disorders and Mental Health Conditions (U01 Clinical Trial Required)
NOFO Number: RFA-MH-19-525
Summary:

In 2015–2016, there were over 2 million adults with an opioid use disorder (OUD); 62% had a co-occurring mental illness and 24% had a co-occurring serious mental illness. Despite the effectiveness of treatment, many individuals never receive it, and when treatment is provided, quality is low. This is a critical treatment gap in a vulnerable and stigmatized population. Collaborative care (CC) aims to address these gaps by improving access, quality, and outcomes in primary care patients with common mental health conditions. However, CC has never been tested with co-occurring disorders (COD). In the team’s CC model for COD (CC-COD), the CC team includes a behavioral health psychotherapist, medications for OUD, pharmacotherapy for depression and post-traumatic stress disorder (PTSD), motivational interviewing (MI), problem-solving therapy, and Seeking Safety. A multisite, randomized pragmatic trial will be conducted to adapt, harmonize, and then test whether CC-COD improves access, quality, and outcomes for patients with comorbid OUD and depression and/or PTSD.

3R01AA025848-03S1
AOD Use Trajectories from Age 10 to 24: Multi-level Predictors, Health and Behavioral Functioning, and Racial/ethnic Disparitie New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIAAA RAND Corporation D'Amico, Elizabeth J. Santa Monica, CA 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

There is a great deal of research aimed at better understanding transitions in alcohol and other drug (AOD) use patterns from early to late adolescence and from late adolescence to emerging adulthood. However, no studies to date have (a) assessments of AOD use from ages 10 to 24 across all developmental periods (middle school, high school, and emerging adulthood); (b) a large sample with substantial racial and ethnic diversity, particularly among Hispanic and Asian youth; (c) in-depth coverage of 10 areas of functioning across three key domains; (d) subjective and objective neighborhood data; or (e) the capacity to examine developmental trajectories for more than one substance. The current proposal is a continuation of previous projects that assessed AOD use across nine waves of data from age 10 to age 19. The proposed study capitalizes on the longitudinal data on protective and risk factors we have collected since age 10 in an ethnically diverse cohort by continuing to annually assess these youth in order to capture important transitions to emerging adulthood (through age 24). By advancing the epidemiology of alcohol use during adolescence and emerging adulthood, our findings can affect prevention and intervention programming for young people and address critical issues of public health policy.

3UH3DA050235-02S1
Development and Implementation of a Culturally Centered Opioid Prevention Intervention for American Indian/Alaska Native Young Adults in California New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA RAND CORPORATION D'AMICO, ELIZABETH Santa Monica, CA 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:

Data from 2015 show that American Indian/Alaska Natives (AI/AN) have the highest rates of diagnosis for opioid use disorders (OUD) and deaths from drug overdose; yet, there are no prevention programs addressing opioid misuse among urban AI/AN young adults that integrate culturally-appropriate strategies with evidence-based treatment. This project proposes to address that gap and help prevent OUD in Older Adolescents and Young Adults (ages 16-30) by developing and implementing a culturally-centered intervention to address opioid misuse among urban AI/AN emerging adults in California. The study will examine outcomes at 3-, 6-, and 12- months, and explore potential mechanisms of change for decreases in opioid and alcohol and other drug use outcomes through mediation analyses, including changes in social networks and cultural connectedness. Results from this study could significantly advance scientific knowledge and clinical practice for AI/AN emerging adults.

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
NOFO Title: NIDA Research Center of Excellence Grant Program (P50)
NOFO 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.

1UG3DA050235-01
Development and Implementation of a Culturally Centered Opioid Prevention Intervention for American Indian/Alaska Native Young Adults in California New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA RAND CORPORATION D'AMICO, ELIZABETH J (contact); DICKERSON, DANIEL LEE Santa Monica, CA 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:

Data from 2015 show that American Indians/Alaska Natives (AI/AN) have the highest rates of diagnosis for opioid use disorder (OUD) and death from drug overdose. Of particular concern is the prevalence in emerging adults (ages 18-25), as this is a developmental period of heightened vulnerability and critical social, neurological, and psychological development. This study will develop and implement a culturally centered intervention to address opioid misuse among urban AI/AN emerging adults in California: POMANAYA (Preventing Opioid Misuse Among Native American Young Adults). POMANAYA will developed by adapting and enhancing our existing culturally sensitive prevention intervention program that uses motivational interviewing in AI/AN youth to address social network factors in emerging adults that amplify (or reduce) opioid and other drug use risk. Results from this study could significantly advance scientific knowledge and clinical practice for AI/AN emerging adults.

1R43HD111082-01A1
Novel Venous Device for the Treatment of Chronic Pelvic Pain Cross-Cutting Research Small Business Programs NICHD V-FLOW MEDICAL, INC. BRENNEMAN, RODNEY San Juan Capistrano, CA 2023
NOFO Title: HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Not Allowed)
NOFO Number: RFA-NS-20-011
Summary:

Pelvic venous compression is a common cause of chronic pelvic pain in women. Because many women do not receive an accurate diagnosis for the cause of their pelvic pain, some take opioids to help manage their symptoms. This project will further develop a new diagnostic system specifically designed to treat limited blood flow in pelvic region. This system visualizes pelvic veins toward development of a method to relieve pressure that causes pain. 

1U01DA051071-01A1
Process Development, Manufacturing, and Preclinical Evaluation of a Monoclonal Antibody for Fentanyl Overdose Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA CESSATION THERAPEUTICS, LLC Bremer, Paul T. San Jose, CA 2020
NOFO Title: Grand Opportunity in Medications Development for Substance-Use Disorders (U01 - Clinical Trial Optional)
NOFO Number: PAR-19-327
Summary:

Opioid use disorder (OUD) is a significant public health problem in the United States. Particularly troubling is the rapid evolution of an opioid epidemic within the past decade, characterized by a surge in unintentional overdose deaths involving synthetic opioids, such as fentanyl. The current standard of care for opioid overdose is reversal with opioid antagonist naloxone. Naloxone is effective at reversing overdose from prescription opioids and heroin, but less effective when combating fentanyl, due to fentanyl?s high potency. Therapeutic monoclonal antibodies (mAbs) against fentanyl could overcome this problem by specifically preventing the drug from entering the central nervous system, averting overdose and attenuating opioid-induced respiratory depression. This study will develop and design of laboratory protocols needed to establish a Good Manufacturing Practice (GMP) process, quality assurance protocol, and stability profile for a new human mAb against fentanyl. Subsequent production of current GMP material will enable Good Laboratory Practice (GLP) toxicology studies in rats and dogs and eventually a Phase I/IIa clinical trial. This material will also be used in final opioid-induced respiratory depression studies in mice and non-human primates to confirm therapeutic efficacy of final drug product. If successful, these activities will enable filing for an investigational new drug application for this mAb candidate with the FDA.

3U19AR076737-01S2
REACH Participant Diversity Program Clinical Research in Pain Management Back Pain Consortium Research Program NIAMS UNIVERSITY OF CALIFORNIA, SAN FRANCISCO LOTZ, JEFFREY C San Francisco, CA 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 University of California, San Francisco, as part of the Back Pain Consortium (BACPAC) Research Program, has established a Core Center for Patient-centric Mechanistic Phenotyping in Chronic Low Back Pain (REACH). The main goal of REACH is to define different subtypes (phenotypes) of chronic low back pain as well as to identify underlying pain mechanisms that can lead to effective, personalized treatments for patients across all population subgroups. To achieve this goal, REACH is, or will be, participating in several clinical trials, and it is imperative that the patients participating in these trials reflect the diversity of the U.S. population. Therefore, this project seeks to adapt methods that have successfully improved minority participation in other settings as well as to develop and deploy digital strategies that can promote recruitment and engagement of patients from marginalized populations.

1R61NS129050-01
Integrating Nonpharmacologic Strategies for Pain with Inclusion, Respect, and Equity (INSPIRE): Tailored Digital Tools, Telehealth Coaching, and Primary Care Coordination Clinical Research in Pain Management Advancing Health Equity in Pain Management NINDS University of California, San Francisco SATTERFIELD, JASON M San Francisco, CA 2022
NOFO Title: HEAL Initiative: Advancing Health Equity in Pain Management (R61/R33 Clinical Trial Required)
NOFO Number: NS22-002
Summary:

There is a need to improve access to treatments and address the stigma, bias, and mistrust that harm and isolate people with chronic pain, especially those from ethnic and racial minority populations. The Integrating Nonpharmacologic Strategies for Pain with Inclusion, Respect, and Equity (INSPIRE) Chronic Pain (CP) intervention blends cognitive-behavioral therapy, physical therapy, mindfulness, and pain education, and is delivered by a trilingual mobile app and supported by a telehealth pain coach who coordinates with doctors. The coach will collect and summarize patient reports on pain, depression, anxiety, substance use, and social factors, and share them with healthcare providers. In this project, researchers will create the digital tool and coaching protocol, develop educational and implementation strategies for healthcare providers, and conduct a pilot test. They will then perform a randomized clinical trial to compare INSPIRE to current treatment, analyze its effects, and evaluate outcomes.

1R61MD018333-01
Group-Based Integrative Pain Management: A Multi-Level Approach to Address Intersectional Stigma and Social Isolation in Diverse Primary Care Safety Net Patients with Chronic Pain Clinical Research in Pain Management Advancing Health Equity in Pain Management NIMHD University of California, San Francisco CHAO, MARIA San Francisco, CA 2022
NOFO Title: HEAL Initiative: Advancing Health Equity in Pain Management (R61/R33 Clinical Trial Required)
NOFO Number: NS22-002
Summary:

Many barriers exist in primary care offices where socioeconomically disadvantaged patients are most often treated. This project seeks to address chronic pain disparities that affect racially diverse, socioeconomically disadvantaged individuals. The study aims to optimize multimodal pain management in primary care clinics for low-income populations. This study includes two group-based models: integrative group medical visits and group acupuncture. These two interventions will be compared to typical treatment to measure both pain interference and social isolation. National experts and patient stakeholders will refine and optimize the design of the study with English- or Spanish-speaking patients with chronic pain in two primary care clinics for low-income populations.

1R43DA049623-01
Non-invasive Neuromodulation Device for Decreasing Withdrawal Symptoms and Craving during Treatment of Opioid Use Disorder Cross-Cutting Research Small Business Programs NIDA THERANOVA, LLC JAASMA, MICHAEL San Francisco, CA 2019
NOFO Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
NOFO Number: RFA-DA-19-019
Summary:

Opioid use disorder (OUD) can be lethal, with opioid overdose causing more than 115 deaths in the U.S. each day. Although medications are effective at reducing illicit opioid use and overdose deaths, it is well-established that withdrawal and craving are highest in the initial weeks, making this a high-risk period for treatment dropout, relapse, and overdose. Adjunct therapies that can reduce early opioid withdrawal and craving may improve retention in treatment with buprenorphine-naloxone, and recent research has shown that stimulation of a peripheral nerve significantly modulates withdrawal- and craving-related responses for opioids and other drugs. This project will test the effectiveness of the EMPOWER Neuromodulation System, a portable, non-invasive transcutaneous electrical nerve stimulation (TENS) device developed by TheraNova for the treatment of OUD.

3UG1DA015815-17S7
Subthreshold Opioid Use Disorder Prevention (STOP) Trial New Strategies to Prevent and Treat Opioid Addiction Prevention of Progression to Moderate or Severe Opioid Use Disorder NIDA University of California, San Francisco SORENSEN, JAMES L San Francisco, CA 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.

1UH2AR076719-01
Novel imaging of endplate biomarkers in chronic low back pain Clinical Research in Pain Management Back Pain Consortium Research Program NIAMS UNIVERSITY OF CALIFORNIA, SAN FRANCISCO FIELDS, AARON J (contact); KRUG, ROLAND San Francisco, CA 2019
NOFO Title: HEAL Initiative: Back Pain Consortium (BACPAC) Research Program Technology Research Sites (UH2/UH3 Clinical Trial Optional)
NOFO Number: RFA-AR-19-028
Summary:

This project will examine the association between end plate pathology and chronic low back pain (cLBP) and improve patient selection by developing and translating new imaging tools, technologies, and/or methods (iTTM) that provide accurate, noninvasive measures of end plate pathologies. A search for clinically relevant biomarkers of end plate pathology will focus on novel imaging measures of end plate bone marrow lesion (BML) severity with IDEAL MRI and cartilage endplate (CEP) fibrosis/damage with UTE MRI, assess interactions with paraspinal muscles, and identify metrics that associate with pain, disability, and degeneration. The research will refine imaging and post-processing methodologies by leveraging and expanding existing cross-sectional cohorts and then deploy and validate the new end plate iTTM to other BACPAC sites to test the most promising metrics’ clinical utility. These studies will provide validated iTTM that are useful for addressing the end plates pathology’s role in cLBP, identifying sub-phenotypes, discovering pain mechanisms, uncovering treatment targets, and selecting patients.