Funded Projects

NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-020
Summary:

The HEALthy Brain and Child Development National Consortium (HBCD-NC) will establish a normative model of developmental trajectories over the first 10 years of life. All sites in the HBCD-NC will carry out a common research protocol and will assemble and distribute a comprehensive research dataset to the scientific community. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. Most  participants will be recruited in the second trimester of pregnancy, with a smaller subset recruited at birth, and followed for the first 10 years of life. The Boston Children’s Hospital study site is in Massachusetts, which has the fifth highest rate of opioid use in the U.S., and twice the U.S. average incidence of opioid use disorder in delivering mothers.

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-22-110
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.

NOFO Title: Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
NOFO Number: RFA-DA-19-002
Summary:

Methadone maintenance therapy has been shown to facilitate recovery and prevent deaths from opioid use disorder (OUD). This proposal is for development of a once-weekly oral methadone for maintenance therapy for OUD. Lyndra has developed an oral gastric residence dosage form that has been demonstrated to provide at least seven days of continuous delivery. A once-weekly oral methadone product could lower a major barrier to treatment for many patients, reduce the stigma and socioeconomic impact of medication-assisted therapy, and increase the capacity of methadone treatment centers by reducing the number of patient visits. This study will perform pharmaceutical development and pharmacological characterization of a once-weekly oral methadone dosage form, leading to the selection of a clinical candidate for a first-in-human trial and submission of an IND. Clinical trials will then be performed to evaluate the safety and pharmacokinetics of the once-weekly oral methadone dosage form in subjects with OUD.

NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (Collaborative R34 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-029
Summary:

A more than 5-fold increase in the incidence of neonatal abstinence syndrome has been reported since 2000. Preliminary studies show that prenatal opioid exposure is associated with increased risk of impaired neurodevelopment. Five institutions (Duke University, Arkansas Children’s Research Institute, Cincinnati Children’s Hospital, University of Illinois at Urbana–Champaign, and University of North Carolina at Chapel Hill) have formed a consortium to develop strategies for the Phase II HEALthy Brain and Child Development Study. Research teams will develop instruments and strategies (recruitment/retention protocols, assessment batteries, and novel tools); conduct pilot studies (fetal and postnatal imaging, advanced imaging harmonization and quality control, assessment administration, biosampling) to evaluate instruments; and analyze available data, including imaging, behavioral, cognitive, and maternal data from studies on early brain development, to guide the Phase II study design. Upon completion, the consortium aims to conduct the Phase II study.

NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (R34 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-036
Summary:

Structural and functional neuroimaging measures are prone to errors induced by subject motion. Many comorbid features of opioid exposure are likely to increase children’s in-scanner motion. In total, this raises substantial concern that existing neuroimaging methods are not sufficiently motion-robust to be used in studies of children ages 3–5. Researchers will address these concerns with a feasibility study, comparing the existing methods developed for the Adolescent Brain Cognitive Development (ABCD) study with novel methods we will develop and optimize for young children. They will evaluate research methods in a sample of 100 children and test whether novel technologies improve the quality of the raw imaging data and reduce motion biases in the derived measures. Researchers will determine predictors of successful imaging to inform sampling strategies in future studies. The primary outcomes will be novel, validated structural and functional neuroimaging imaging methods for young children and feasibility data to inform the design of future studies addressing developmental questions, particularly those related to opioid exposure.

NOFO Title: Grand Opportunity in Medications Development for Substance-Use Disorders (U01)
NOFO Number: PAR-19-327
Summary:

Currently no medications are approved by the U.S. Food and Drug Administration for psychostimulant (cocaine and methamphetamine) use disorder. This project will develop a novel opioid molecule (PPL-138) that blocks cocaine and methamphetamine self-administration in animal models and that lacks rewarding properties that could lead to addiction. This research will conduct manufacturing and safety studies to prepare for Phase 1 clinical trials to determine safety in human patients.

NOFO Title: Biased Mu-Opioid Receptor Analgesics to Prevent Overdose and Opioid Use Disorders
NOFO Number: PA-20-272
Summary:

There is an urgent need for a new generation of non-addictive, pain-relieving medications that do not cause problematic side effects like breathing problems or constipation. The overarching project is testing a new potential medication that interacts in a new way with the opioid system in human research participants. This supplement will help cover costs associated with the Safety Review Committee meeting required by the U.S. Food and Drug Administration.

NOFO Title: Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
NOFO Number: RFA-DA-19-002
Summary:

Chronic pain affects an estimated 100 million Americans, or one third of the U.S. population, and it is the primary reason Americans are on disability. Although many treatments are available for pain, the most potent class of analgesics relies on opioid analogs, whose limitations and well-known adverse effects have contributed to the present opioid crisis. New pharmacotherapies for pain management are sorely needed. MTX1604, a synthetic endomorphin analog, has emerged as a highly effective analgesic that exhibits reduced reward potential and respiratory suppression, and a robust duration of efficacy in a variety of validated animal models of acute, neuropathic, inflammatory, post-operative, and visceral pain. This project will generate additional preclinical characterization data of MTX1604 and advance clinical development toward FDA approval. If successful, this medication development project could offer patients a novel non-addictive, potent, and safe analgesic and thus have a direct impact on the opioid crisis.

NOFO Number:
Summary:

People who use opioids in rural areas suffer worse health and less insurance coverage. The opioid problem in rural areas is of particular concern, as rural areas have higher overdose rates despite equivalent rates of OUD. This is because rural areas have a scant number of clinics and clinicians who provide medication treatment for OUD. Thus, people living in rural areas must travel long distances to access clinics that may or may not have expertise in providing treatment to patients with OUD. Telemedicine (TM) could efficiently increase capacity for delivery of buprenorphine in rural areas and may increase the number of patients receiving medication treatment and improve treatment retention and outcomes. While the development of medication treatments for opioid use disorder (MOUD) capacity in primary care settings with optimal/comprehensive services is desirable, the current opioid crisis with escalating overdose death rates in rural areas suggests a need to implement an efficient, cost-effective system of MOUD services that can be scaled up quickly. The use of a centralized and Medicare-covered TM vendor utilizing a developed methodology and established organizational infrastructure offers the great potential for a rapid rollout to increase access to MOUD and improve treatment retention in rural areas. This cluster randomized clinical trial with two phases will test expanded treatment access to improve retention on MOUD in highly affected rural areas. Phase I will include implementing telemedicine in a limited number of rural sites with varying levels of office-based opioid treatment (OBOT) to inform implementation strategies for the main trial, and Phase II will include evaluate comparative effectiveness between OBOT alone and OBOT + TM at 30 sites.

NOFO Title: HEAL Initiative: Planning Grants for Efficacy or Effectiveness Trials of Recovery Support Services for Individuals Treated with Medications for Opioid Use Disorder (R34 Clinical Trial Optional)
NOFO Number: RFA-DA-22-034
Summary:

Patients choosing treatment with medications for opioid use disorder as part of their recovery pathway often have difficulties staying on these medications for extended periods of time. Currently, no established evidence-based interventions are available to help. This project will leverage the impact of two widely used recovery support services: peer recovery support services and recovery housing. Delivered by community-based peers with lived recovery experience, the intervention will include assertive outreach, which encourages people in recovery between episodes of care to continue treatment and return to care after treatment dropout and/or resumed opioid use. This research will also examine whether these services can enhance benefits offered by the supportive recovery housing living environment.

NOFO Title: HEALing Communities Study: Developing and Testing an Integrated Approach to Address the Opioid Crisis (Research Sites) (UM1 - Clinical Trial Required)
NOFO Number: RFA-DA-19-016
Summary:

Although there are effective prevention and treatment programs and services to address opioid misuse, opioid use disorder (OUD), and overdose, gaps remain between those needing and those receiving prevention and treatment, in part because of a need to better understand how to make these programs and services most effective at a local level. The National Institutes of Health (NIH) and the Substance Abuse and Mental Health Services Administration (SAMHSA) launched the HEALing Communities Study to generate evidence about how tools for preventing and treating opioid misuse and OUD are most effective at the local level. This multisite implementation research study will test the impact of an integrated set of evidence-based practices across health care, behavioral health, justice, and other community-based settings. The goal of the study is to reduce opioid-related overdose deaths by 40 percent over three years. Columbia University is partnering with academic institutions in three other states to study the impact of these efforts in 67 highly affected communities. The study will also look at the effectiveness of coordinated systems of care designed to increase the number of individuals receiving medication to treat OUD, increase the distribution of naloxone, and reduce high-risk opioid prescribing.

NOFO Title: HEAL Initiative: Integrative Management of Chronic Pain and OUD for Whole Recovery (IMPOWR): Research Centers (RM1 Clinical Trial Required)
NOFO Number: RFA-DA-21-030
Summary:

The goal of the Tailored Retention and Engagement for Equitable Treatment of Opioid use disorder (OUD) and Pain (TREETOP) research program is to develop effective, equitable, and sustainable interventions for chronic pain and opioid misuse/disorder that improve engagement in medication for opioid misuse/disorder treatment and retention in office-based addiction treatment. TREETOP will prioritize disproportionately affected rural and Black communities. The Engagement research project will investigate whether pain self-management can improve pain and engage primary care patients to seek medication treatment for opioid misuse/disorder. The Retention project will investigate whether pain self-management and/or flexibly dosed buprenorphine/naloxone can improve pain and retention in treatment among patients who have already begun care in office-based addiction treatment programs. With engagement from stakeholders and representatives with varied perspectives and lived experiences, this research will advance the science of sustainably and equitably managing chronic pain and opioid misuse/disorder, prioritizing disproportionately affected communities.

NOFO Title: Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)
NOFO Number: PA-21-071
Summary:

The International Classification of Diseases 10th revision codes are insufficient to accurately identify individuals who use opioids and stimulants together. This project will search already collected electronic health record data using a computer program to identify people with polysubstance use and determine what health care they receive. The research will improve understanding of polysubstance use in a region of Los Angeles, California, with very high rates of overdoses involving fentanyl and stimulants.