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 descending Year Awarded
3UG3NS123958-01S1
Neuroimmune Mechanisms of a Humanized CCK-B Receptor scFv as Therapy for Chronic Pain Patients Cross-Cutting Research Training the Next Generation of Researchers in HEAL NINDS University of New Mexico WESTLUND-HIGH, KARIN N Albuquerque, NM 2022
NOFO Title: Research Supplements to Promote Diversity in Health-Related Research (Admin Supp Clinical Trial Not Allowed)
NOFO Number: PA21-071
Summary:

There are currently few effective therapies available for chronic nerve injury-induced pain, associated anxiety, and depression. This project aims to extend previous research aiming to uncover the mechanism of action of artificially modified immune molecules (humanized cholecystokinin-2 receptor [CCKBR] single-chain variable fragments [scFv]) on human neurons and how it reverses chronic pain and anxiety-like behaviors in mouse models. This potential treatment approach offers important advantages over existing therapies, including extreme specificity, higher affinity, brain/nerve penetrance, safety, and reduced self-immunogenicity.

3RM1DA055301-01S1
Integrative Treatment for Achieving Holistic Recovery from Comorbid Chronic Pain and Opioid Use Disorder Cross-Cutting Research Training the Next Generation of Researchers in HEAL NIDA UNIVERSITY OF NEW MEXICO WITKIEWITZ, KATIE A; PEARSON, MATTHEW RYAN Albuquerque, NM 2022
NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for PA-20-222: Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)
NOFO Number: NOT-NS-20-107; PA-21-071
Summary:

Few integrated treatments are available that simultaneously address the fundamental causes of chronic pain and opioid misuse/opioid use disorder and focus on well-being among individuals with chronic pain and opioid misuse/opioid use disorder. This research will inform development of patient-centered interventions that increase quality of life and engagement in valued activities, are culturally appropriate for use by diverse patient populations, and reduce stigma related to chronic pain and opioid misuse/opioid use disorder. The results of this project will be used to inform future research focused on developing mobile health treatments for individuals with chronic pain and opioid use disorder, and for developing culturally appropriate treatments for chronic pain and opioid use disorder in Hispanic/Latino individuals.

3UH3DA047925-03S1
Development of a 3-Month Implantable Depot Pellet of Naltrexone for the Treatment of Opioid Use Disorder Cross-Cutting Research Leveraging Existing and Real-Time Opioid and Pain Management Data NIDA BIOCORRX, INC. MALLON, ANDREW PETER Anaheim, CA 2022
NOFO Title: Notice of Special Interest (NOSI): Availability of Administrative Supplements for Helping to End Addiction Long-term (HEAL) Initiative awardees to make data Findable, Accessible, Interoperable, and Reusable (FAIR) through the HEAL Data Ecosystem
NOFO Number: NOT-OD-22-033
Summary:

This research provides support to strengthen data management, data sharing, and data readiness efforts within the HEAL Initiative. This support further fosters collaboration among HEAL awardees and enables maximal data discoverability, interoperability, and reuse by aligning with the FAIR (Findable, Accessible, Interoperable, and Reusable) principles. It also provides an opportunity for existing HEAL Initiative award recipients to increase data “FAIR”-ness, participate in coordinated HEAL Initiative activities to build community around data sharing, and foster sustainability of HEAL Initiative digital assets.

1R21DE032584-01
Identifying Chronic Pain Phenotypes and Treatment Disparities in Adults with Cerebral Palsy Cross-Cutting Research Leveraging Existing and Real-Time Opioid and Pain Management Data NIDCR UNIVERSITY OF MICHIGAN PETERSON, MARK D Ann Arbor, MI 2022
NOFO Title: HEAL Initiative: Secondary Analysis and Integration of Existing Data Related to Acute and Chronic Pain Development or Management in Humans (R21 Clinical Trials Not Allowed)
NOFO Number: RFA-DE-22-011
Summary:

Cerebral palsy is the most common physical disability in children. Those who have this condition experience pain throughout their lives. Although opioids are generally not recommended, many adults with cerebral palsy are prescribed them for pain. This project will assess the incidence of chronic pain conditions in adults with and without cerebral palsy as well as measure opioid treatment-related health outcomes in adults with cerebral palsy. This research will also evaluate pain treatment disparities related to race/ethnicity and insurance coverage using national medical claims databases.

3U19AR076734-01S5
University of Michigan BACPAC Mechanistic Research Center Cross-Cutting Research Training the Next Generation of Researchers in HEAL NIAMS UNIVERSITY OF MICHIGAN CLAUW, DANIEL J; HASSETT, AFTON L Ann Arbor, MI 2022
NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for Administrative Supplements to Support Career Enhancement Related to Clinical Research on Pain (Admin Supp – Clinical Trial Not Allowed)
NOFO Number: NOT-NS-22-087
Summary:

Many medication-based and complementary/integrative interventions are available to treat chronic low back pain, yet no treatment works for all patients. This clinical research strives to understand patient characteristics that predict differential responses to chronic low back pain interventions such as acupressure. This knowledge will enable early career researchers and clinicians to develop tailored treatments for individual patients.

1K12NS130673-01
University of Michigan (UM) HEAL Initiative National K12 Clinical Pain Career Development Program (UM-HCPDP) Cross-Cutting Research Training the Next Generation of Researchers in HEAL NINDS UNIVERSITY OF MICHIGAN WILLIAMS, DAVID A (contact); CLAUW, DANIEL J; HARTE, STEVEN EDWARD Ann Arbor, MI 2022
NOFO Title: HEAL Initiative: National K12 Clinical Pain Career Development Program (K12 Clinical Trial Not Allowed)
NOFO Number: RFA-NS-22-045
Summary:

The Interagency Pain Research Coordinating Committee has reported that early-stage investigators are leaving the clinical pain research workforce for other fields. In addition, pain clinician researchers at the senior/mentor level are also exiting the field. This project will create a national training center for early-career clinicians and scientists interested in pursuing and sustaining independent careers in clinical pain research. Research will focus on rigorous scientific methods and procedures in pain research as well as the importance of stakeholder engagement.

3UM1NS118922-03S2
Transition from Acute to Chronic Pain After Thoracic Surgery Cross-Cutting Research Increasing Participant Diversity, Inclusion, and Engagement in HEAL Research NINDS UNIVERSITY OF MICHIGAN BRUMMETT, CHAD M; CHANG, ANDREW CHING-HUNG; CLAUW, DANIEL J; WALJEE, JENNIFER FILIP Ann Arbor, MI 2022
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-22-066
Summary:

Rigorous and impactful clinical pain research requires participant diversity that reflects the racial/ethnic diversity of affected populations. This project will enhance patient and other community engagement, particularly of underrepresented minorities, to participate in clinical research related to the transition of acute to chronic pain.

1R43NS125643-01
Development of an intranasal, direct to nerve treatment for headache disorders Cross-Cutting Research Small Business Programs NINDS Olfax, LLC BECKWITH, JONATHAN G (contact); COOK, JASON T Asheville, NC 2022
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:

About 14% of U.S. adults report experiencing migraine symptoms within any given 3-month period, making it the second most disabling illness in the world. Nonspecific pain medications used in migraine (e.g., acetaminophen, nonsteroidal inflammatory drugs, opioids) are often not effective for severe migraine symptoms or cause significant adverse effects. A research team of migraine care specialists, device and drug developers, and clinical research specialists has created a technology for accurately delivering self-administered migraine medication to the upper nasal cavity. The technology enables development of a self-administered therapy to provide rapid pain relief without harsh and addictive side effects of existing migraine medications. This project will establish efficacy and evaluate commercial design feasibility for this treatment.

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. Cross-Cutting Research Small Business Programs NIDA MMJ LABS, LLC BAXTER, AMY LYNN Atlanta, GA 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:

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.

1R01DA057599-01
Mining Social Media Big Data for Toxicovigilance: Studying Substance Use via Natural Language Processing and Machine Learning Methods Cross-Cutting Research Leveraging Existing and Real-Time Opioid and Pain Management Data NIDA EMORY UNIVERSITY SARKER, ABEED H Atlanta, GA 2022
NOFO Title: HEAL Initiative: Data and Methods to Address Urgent Needs to Stem the Opioid Epidemic (R01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-22-044
Summary:

Monitoring and reporting substance use and substance use disorder is difficult to obtain in real-time using conventional methods. However, social media captures large amounts of data about substance use that are reported by diverse groups of people. Analysis of these data can provide population- or subpopulation-level insights, at low cost and in near real-time. This project aims to convert large amounts of social media data on substance use into actionable knowledge using advanced natural language processing and artificial intelligence approaches. The researchers will publicly release the aggregated statistics through a dedicated dashboard and provide user-friendly, open-source tools to determine trends and analyze disparities.

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 Cross-Cutting Research Small Business Programs NIDA SYNTRIX BIOSYSTEMS, INC. Kahn, Stuart J Auburn, WA 2019
NOFO Title: PHS 2017-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44])
NOFO 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.

1R61DA057610-01
Improving Pain Management and Opioid Safety Through a Systemwide, Data Driven Evaluation of the CDC Opioid Prescribing Guideline Best Practices and the Use of Clinical Decision Support Cross-Cutting Research Translating Data 2 Action to Prevent Overdose NIDA UNIVERSITY OF COLORADO DENVER HOPPE, JASON Aurora, CO 2022
NOFO Title: HEAL Initiative: HEAL Data2Action Innovation Projects
NOFO Number: RFA-DA-22-051 
Summary:

Clinical decision support tools help clinicians make treatment decisions based on routinely collected data and offer a promising strategy to implement evidence-based practices for safe and effective pain management. This project will use clinical decision support tools embedded into electronic health records to help healthcare providers make treatment decisions that align with opioid prescribing guidelines from the Centers for Disease Control and Prevention (CDC). The project will also use information from prescription drug monitoring programs, insurance claims, and mortality data to evaluate patient outcomes. This research will evaluate how prescribing practices that align with CDC guidelines affect patient outcomes and whether clinical decision support tools provide an advantage over standard care practices for pain management.

1R21DE032532-01
Secondary Analysis and Integration of Existing Data Related to Chronic Orofacial Pain and Placebo Effects Cross-Cutting Research Leveraging Existing and Real-Time Opioid and Pain Management Data NIDCR UNIVERSITY OF MARYLAND, BALTIMORE COLLOCA, LUANA (contact); DORSEY, SUSAN G Baltimore, MD 2022
NOFO Title: HEAL Initiative: Secondary Analysis and Integration of Existing Data Related to Acute and Chronic Pain Development or Management in Humans (R21 Clinical Trials Not Allowed)
NOFO Number: RFA-DE-22-011
Summary:

Temporomandibular joint (TMJ) disorders, which affect the joint connecting the lower jaw and the skull, are common and difficult chronic pain conditions. Pain management strategies that harness the body’s own pain relief mechanisms (including placebo effects in which pain relief cannot be attributed to a specific treatment), can reduce the severity and duration of TMJ-related chronic pain. Although research suggests that placebo effects may have a genetic basis, few, if any, genetic studies have examined this possibility in individuals with TMJ disorders. This project will use in-depth genetic, sociodemographic, clinical, and psychological data collected from adults with chronic TMJ disorders to better understand how the placebo effect works.

1R21AG082345-01
Assessing Chronic Pain Using Brain Entropy Mapping Cross-Cutting Research Leveraging Existing and Real-Time Opioid and Pain Management Data NIA UNIVERSITY OF MARYLAND, BALTIMORE WANG, ZE Baltimore, MD 2022
NOFO Title: HEAL Initiative: Secondary Analysis and Integration of Existing Data Related to Acute and Chronic Pain Development or Management in Humans (R21 Clinical Trials Not Allowed)
NOFO Number: RFA-DE-22-011
Summary:

Chronic pain affects millions of Americans and remains poorly understood and challenging to manage. Researchers do not fully understand brain processes involved in chronic pain, which can vary considerably from person to person. This project will analyze brain function using magnetic resonance imaging (MRI) in individuals with and without chronic pain. The research will also directly determine the degree of pain-related brain imaging changes by using a large database of brain imaging data.

1R01DA057685-01
Identifying Suspected Drug Overdose Deaths in Near Real-Time Using Data Collected by Death Investigators Cross-Cutting Research Leveraging Existing and Real-Time Opioid and Pain Management Data NIDA FRIENDS RESEARCH INSTITUTE, INC. HOCHSTATTER, KARLI RAE Baltimore, MD 2022
NOFO Title: HEAL Initiative: Data and Methods to Address Urgent Needs to Stem the Opioid Epidemic (R01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-22-044
Summary:

Effective responses to the highly dynamic overdose crisis require accurate and timely information about the timing and location of drug overdoses, which is currently reported mainly through death certificates that take time to become available and thus limit life-saving responses. This project will comprehensively evaluate, optimize, and assess barriers and facilitators to adoption of a surveillance tool developed by the New York City Office of the Chief Medical Examiner. The tool uses data routinely collected during death investigations to predict in near real-time whether a death was due to an unintentional drug overdose. The findings will inform drug overdose mortality surveillance efforts in other states.

3UH3AR077360-04S1
A sequenced-strategy for improving outcomes in patients with knee osteoarthritis pain Cross-Cutting Research Training the Next Generation of Researchers in HEAL NIAMS JOHNS HOPKINS UNIVERSITY CAMPBELL, CLAUDIA MICHELLE (contact); CASTILLO, RENAN C; COHEN, STEVEN P Baltimore, MD 2022
NOFO Title: Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)
NOFO Number: PA-21-071
Summary:

Knee osteoarthritis is one of the leading causes of chronic pain and disability worldwide, affecting more than 30% of older adults. Rates of this condition have more than doubled in the past 70 years and continue to grow sharply, given increases in life expectancy and body mass index among the U.S. population. This project supports a scientist from a group underrepresented in biomedicine to expand ongoing clinical research comparing various non-medication-based treatments for knee osteoarthritis.

1R43NS132623-01
Optogenetic Pain Modulator for Non-Opioid Chronic Pain Management Cross-Cutting Research Small Business Programs NINDS OPSIN BIOTHERAPEUTICS, INC. NARCISSE, DARRYL Bedford, TX 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:

Optogenetics is a method of controlling nerve or brain activity using light-sensitive cell receptors (opsins). Optogenetics has been used in brain research for decades, allowing researchers to understand the brain and its associated disorders by selectively turning on and off specific nerve cells. This project will develop and refine use of an opsin and a light-stimulation device to control nerve cells contributing to the sensation of pain. 

2R44DA049300-02
Prapela™ SVS: A cost-effective stochastic vibrotactile stimulation device to improve the clinical course of infants with neonatal abstinence syndrome Cross-Cutting Research Small Business Programs NIDA PRAPELA, INC. KONSIN, JOHN PHILLIP Biddeford, ME 2021
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:

Infants exposed to opioids in the womb may suffer from neonatal opioid withdrawal syndrome (NOWS). They experience symptoms such as excessive crying, irritability, rapid breathing, elevated heart rates, tremors, and sometimes seizures. There is no accepted standard treatment for NOWS; infants are treated with pharmacological (opioid administration and gradual weaning) and nonpharmacological measures. Nonpharmacological care such as swaddling, rocking, frequent feedings, and skin contact, are time consuming, placing a substantial burden on hospitals with limited resources. Prapela, Inc. previously developed a hospital bassinette pad that, using stochastic vibrotactile stimulation (SVS) technology, very gently rocks infants with NOWS to reduce irritability and other symptoms without disturbing sleep patterns. This project will conduct an additional clinical study to determine the SVS bassinette pad’s efficacy in reducing breathing and heart rate, its safety, and its acceptability with clinical staff and parents caring for infants with NOWS.

1R61DA059163-01
Supporting Data-Driven Decision-Making to Support Substance Use Service Expansion Policies and to Prevent Overdoses Cross-Cutting Research Translating Data 2 Action to Prevent Overdose NIDA CHESTNUT HEALTH SYSTEMS, INC. CRUDEN, GRACELYN Bloomington, IL 2023
NOFO Title: HEAL Initiative: HEAL Data2Action – Innovation and Acceleration Projects, Phased Awards (R61/R33, Clinical Trial Optional)
NOFO Number: RFA-DA-23-057
Summary:

Oregon ranks last in the United States for access to substance use services, having passed a novel ballot measure bringing unprecedented funding levels to expand services and decriminalize possession of personal amounts of substances. This project will develop and evaluate a strategy to inform development of the policy. Cross-sector participants (e.g., community service providers, law enforcement, advocates) will co-design protocols for linking and distributing substance use service data through reports, simulations, and dashboards. This research will test the usability of the developed products and their impact of DDS on service gaps, evidence-based decision-making, quality of evidence-based services, service recipient outcomes, and cross-sector collaboration. The research will also help state decision makers implement strategies for other substance use policies.

3UM1DA049412-04S1
MassHEAL - Reducing overdose deaths by 40% (2019-2023) Cross-Cutting Research Training the Next Generation of Researchers in HEAL NIDA BOSTON MEDICAL CENTER SAMET, JEFFREY Boston, MA 2022
NOFO Title: Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)
NOFO Number: PA-21-071
Summary:

Although there are effective prevention and treatment programs and services to address opioid misuse, opioid use disorder, and overdose, gaps remain between those needing and those receiving prevention and treatment. There is a need to better understand how to make these programs and services most effective at a local level, a problem being addressed by the HEALing Communities Study. This project supports a scientist from a group underrepresented in biomedicine to continue ongoing work to test the impact of an integrated set of evidence-based practices across health care, behavioral health, justice, and other community-based settings.

1DP2HD112176-01
Identifying Plasma Proteomic Profiles of Chronic Pain Development in Endometriosis From Adolescence to Adulthood Cross-Cutting Research Training the Next Generation of Researchers in HEAL NICHD BRIGHAM AND WOMEN'S HOSPITAL SASAMOTO, NAOKO Boston, MA 2023
NOFO Title: Emergency Awards: HEAL Initiative- New Innovator Award (DP2 Clinical Trial Not Allowed)
NOFO Number: RFA-TR-22-013
Summary:

Endometriosis is a gynecologic disorder characterized by severe pelvic pain, affecting 10% of reproductive aged women and adolescents worldwide. These individuals are at an increased risk for chronic opioid use, dependence, and overdose. Adolescents and young adults in particular are understudied in endometriosis research. This project will conduct a longitudinal study of adolescent endometriosis. The research will identify novel biomarkers and biological pathways involved in the transition of acute to chronic pain. The research aims to improve non-surgical endometriosis diagnosis, risk, and treatment. 

1K99AR083482-01
Elucidating the Neuroimmune Mechanisms Underlying Pain and Inflammation in Autoimmune Arthritis Cross-Cutting Research Training the Next Generation of Researchers in HEAL NIAMS BOSTON CHILDREN'S HOSPITAL JAIN, AAKANKSHA Boston, MA 2023
NOFO Title: HEAL Initiative Advanced Postdoctoral-to-Independent Career Transition Award in PAIN and SUD Research (K99/R00 Independent Clinical Trial Not Allowed)
NOFO Number: RFA-NS-22-022
Summary:

Rheumatoid arthritis is an autoimmune disease characterized by episodes of joint inflammation and pain. There are currently no safe and effective treatments that achieve long-term remission of the condition or the associated pain. Many patients use opioid medications to manage the pain and are at increased risk of developing opioid use disorder; therefore, additional treatment options are needed. In rheumatoid arthritis, pain-triggering sensory neurons interact with immune cells in the joints. This project aims to dissect the neuroimmune crosstalk underlying pain and inflammation in arthritic joints and uncover novel therapeutic avenues for this painful condition.

1DP2TR004354-01
Scale Up Single-Cell Technologies to Map Pain-Associated Genes and Cells Across the Lifespan Cross-Cutting Research Training the Next Generation of Researchers in HEAL NCATS Massachusetts General Hospital SHU, JIAN Boston, MA 2022
NOFO Title: Emergency Awards: HEAL Initiative- New Innovator Award (DP2 Clinical Trial Not Allowed)
NOFO Number: RFA-tr-22-013
Summary:

Current treatments for chronic pain, including opioids, are not effective for many individuals. Much remains unknown about genes, circuits, and cells that contribute to chronic pain, including how chronic pain changes across the lifespan in certain populations, including infants, children, older people, and pregnant women. This project will develop technology to map the genes, circuits, and cells associated with pain across ages, sexes, and during pregnancy. The technologies will guide the search for new biomarkers for chronic pain diagnosis and treatments.

1R43DE029369-01
A Novel Opioid-Free Targeted Pain Control Method for Acute Post-Operative Localized Pain Related to Oral Surgical Procedures Cross-Cutting Research Small Business Programs NIDCR LAUNCHPAD MEDICAL, LLC JADIA, RAHUL; KAY, GEORGE Boston, MA 2019
NOFO 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)
NOFO Number: PA-18-574
Summary:

There is a compelling need to develop a front line, non-opioid-based acute pain management strategy for outpatient oral surgical procedures. LaunchPad Medical has developed Tetranite® (TN), a novel bone regenerative mineral-organic self-setting adhesive biomaterial. TN has been extensively studied in vivo in a canine jaw model and shown to be effective and well-tolerated. In this project, researchers will demonstrate that drug-loaded TN can be a novel route to providing localized and time release pain medication following wisdom tooth extraction by determining the release profile of various pain medications from TN at different concentrations. The ability to release pain therapeutics in a controlled fashion and directly at the site of injury offers improved pain control following oral surgical procedures without exposing the patient to opioids. This novel approach to pain management can be extended to more invasive orthopedic procedures such as joint replacement, spinal fusions or reconstructive trauma surgery. In Phase II the team will conduct an in vivo study to assess efficacy of medicated TN to address post-operative pain following wisdom tooth odontectomy, optimize incorporation and release of medications in TN formulations, develop cGMP manufacturing process for the compounded product, and ultimately conduct clinical trials for bone void filler using medicated TN.

1R44DA049493-01
A Prescription Digital Therapeutic to Promote Adherence to Buprenorphine Pharmacotherapy for Patients with Opioid Use Disorder Cross-Cutting Research Small Business Programs NIDA PEAR THERAPEUTICS, INC. KERN, AUDREY; PALLONE, DAVINA Boston, MA 2019
NOFO Title: Loyalty and Reward-Based Technologies to Increase Adherence to Substance Use Disorder Pharmacotherapies (R43/R44 - Clinical Trial Optional)
NOFO 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.