Funded Projects

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:

Black/African American and Hispanic/Latino individuals suffer a disproportionate burden of co-occurring substance use and mental illness, in part due to reduced access to culturally responsive quality healthcare, compared to other racial/ethnic groups. In addition, Black/African American and Hispanic/Latino individuals are not well represented in clinical trials that could help reduce these health disparities. This research aims to improve the recruitment of Black/African American and Hispanic/Latino individuals to participate in clinical research related to co-occurring substance use and mental illness. The project will conduct community engagement and community-based participatory research, establishing a bidirectional partnership between researchers and community members.

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:

This project will develop and refine a wearable device (forearm bracelet) designed to rapidly sense and report the presence of opioids in the wearer. This research will optimize this device to provide ultra-high sensitivity, enhanced drug specificity, long-term durability, low power consumption, and cost-effective production. The findings could support a path toward commercialization of this new device.

NOFO Title: HEAL Initiative: Pilot & Feasibility Trials to Improve Prevention and Treatment Service Delivery for Polysubstance Use (R34 Clinical Trial Optional)
NOFO Number: DA22-048
Summary:

Young adults (18 to 26) with a substance use problem have the highest rates of polysubstance use among all age groups. At the same time, individuals in this age group (especially in rural areas) are generally lacking in recovery capital: resources to help them recover from substance use, such as vocational or educational skills. This project will assess the feasibility and acceptability of “Launch,” which uses parental and peer recovery support to increase recovery capital for young adults with polysubstance use. The intervention will use coaching as well as contingency management, a treatment approach in which individuals receive tangible rewards as incentives for desired behaviors such as abstinence. If successful, the findings will inform a future large-scale trial assessing the effectiveness of this approach.

NOFO Title: HEAL Initiative: Advancing Health Equity in Pain and Comorbidities (R61/R33 Clinical Trial Required)
NOFO Number: RFA-NS-22-037
Summary:

More than half of children and adolescents diagnosed with a type of cancer called bone sarcoma experience pain that interferes with daily life. This project will adapt an evidence-based cognitive behavioral therapy mobile app for use with Black and Hispanic adolescents who disproportionately experience pain from this cancer, putting them at risk for opioid misuse. Once fully adapted, this therapy will be paired with a remotely delivered brain stimulation treatment (transcranial direct current stimulation). This research will also examine the impact of patient-reported conditions such as depression, anxiety, and sleep problems, as well as of various social determinants of health, on pain.

NOFO Title: Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3)
NOFO Number: PAR-20-092​
Summary:

The widespread availability of fentanyl and other potent synthetic opioids has dramatically increased opioid-related fatal overdoses. This project will develop and manufacture immune molecules (monoclonal antibodies) to reverse and treat overdose from fentanyl by keeping it out of the brain. This research will advance promising results in animal studies (preventing and reversing fentanyl- and carfentanil-induced breathing problems and irregular heartbeat) to clinical testing in people with opioid use disorder and others at high risk of opioid overdose from accidental or deliberate exposure to fentanyl and fentanyl-like drugs.

NOFO Title: HEAL Initiative: Research Networks for the Study of Recovery Support Services for Persons Treated with Medications for Opioid Use Disorder (R24 Clinical Trial Optional)
NOFO Number: RFA-DA-22-043
Summary:

About 23 million Americans identify as being in recovery from opioid and other substance use disorders. While recovery support services are an established best practice to support people in recovery, there is little scientific evidence to support the efficacy and implementation of peer recovery support services, training approaches, and delivery models. Recovery support services are particularly lacking in the U.S. Southwest and for individuals who choose to take medications for opioid use disorder as part of their recovery pathway. This project will establish the Peer Recovery Innovation Network to address research gaps. This research will incorporate input from people with lived experience in all stages of the recovery process – toward helping to set the research agenda and conducting the research, as well as enhancing infrastructure for peer recovery support services research.

NOFO Title: HEAL Initiative: Advancing Health Equity in Pain and Comorbidities (R61/R33 Clinical Trial Required)
NOFO Number: RFA-NS-22-002
Summary:

Back pain, including low back and neck pain, is one of the most prevalent and disabling pain disorders. Treatment requires ongoing self-management, but most healthcare systems do not support self-care and instead focus on costly, provider-dependent therapies that remain inaccessible to many Black and Hispanic Americans and individuals with less education and income. This project will address these health disparities by developing a personalized self-management treatment program that includes pain education, mindfulness, cognitive behavioral therapy, and exercise – and make it available in community settings.

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: 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: 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.

NOFO Title: HEAL Initiative: Understanding Polysubstance Use and Improving Service Delivery to Address Polysubstance Use (R01 Clinical Trial Optional)
NOFO Number: DA22-047
Summary:

Little is known about what motivates people to use multiple drugs. Understanding these factors is important for tailoring treatment services. Behavioral economic theory, which determines how much value individuals assign to drugs and potential negative consequences, provides a framework to understand the choices people make. This project will identify patterns, motivating factors, and long-term trajectories of opioid-involved polysubstance use behaviors and treatment. This research will use a range of methods to analyze substance use episodes as well as examine motives and preferences associated with polysubstance use behaviors and how they change over time. The findings will be combined into a toolkit to inform timing, type, and tailoring of interventions and policies to guide implementation of effective clinical strategies and policies for managing polysubstance use in healthcare systems.

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.

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:

It is unclear if long-term use of opioids by head and neck cancer patients affects risk for depression, which is higher in this population compared to people without cancer. This knowledge could inform interventions such as increased opioid prescription safety or alternative pain management approaches and could thus help reduce the risk for depression-related outcomes. This project will use data from a national cancer database linked to Medicare claims and a Veterans Administration database to determine whether people with head and neck cancer that take opioid medications for more than 90 days have increased risk for new-onset or worsening depression or suicide death.