The HEAL Initiative

Funding Institute: National Institute on Drug Abuse (NIDA)

The largest study of its kind in addiction science, the HEALing Communities Study (HCS), is coordinating with 67 communities in four states that have been deeply impacted by the opioid epidemic: Kentucky, Massachusetts, New York, and Ohio. In each locality, investment and support empower community leaders and public health officials to implement the opioid overdose prevention and addiction treatment interventions that they think will be most appropriate in their region—with the aim of increasing efficacy, improving treatment outcomes, and significantly reducing opioid-related deaths.

RTI is supporting local efforts and coordinating between study sites by

• Tracking each local group’s interventions by amount of materials distributed and number of individuals reached, along with publicly available data that reflect opioid harm—including number of emergency room visits, hospitalizations, and deaths related to opioid overdose—in that area
• Acting as the Data Coordinating Center (DCC) between each study site, managing defining rules, and importing data from studies and surveys
• Providing communications support for each local public health initiative
• Building standard study infrastructure for each team, including community dashboards that support data-informed decision-making.

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Funding Institute: NIDA

Data show that opioid overdose has become the leading cause of drug-involved overdose death for Americans of all ages. Annual overdose deaths among adolescents and young adults have more than doubled since 1999, a trend that shows no sign of abating. According to NIDA, heroin and other illicit opioids as well as common prescription opioids were involved in 85% of all overdose deaths in young people ages 15–24 in 2019, the most recent year for which the institute has published data.

The NIH HEAL Prevention Cooperative (HPC) supports the development and dissemination of strategies to prevent opioid misuse and OUD among this population. The HPC consists of 10 research projects that are working to test preventive intervention strategies through individual and coordinated approaches; HPC’s purpose is to enhance knowledge related to opioid misuse and OUD prevention among adolescents and young adults between the ages of 15 and 30.

How RTI Supports This Opioid Misuse Prevention Initiative

The NIH HEAL Prevention Coordinating Center (HPCC) at RTI supports individual HPC research projects and works to generate shared insights by collecting, analyzing, and reporting data across projects. The individual HPC opioid use research projects will provide a subset of common study data elements to the HPCC. In turn, the HPCC will prepare the collective HPC data sets and supporting documentation for an NIH-identified data repository to make the data sets available for secondary data analysis.

The HPCC conducts opioid misuse prevention research activities under five specific aims:

• Facilitate HPC coordination and communication, including the dissemination of systematic reviews and other scholarly works.
• Provide implementation science consultation and facilitate implementation research that spans HPC research projects.
• Establish data infrastructure.
• Provide data harmonization as well as methodological and statistical consultation; lead and facilitate cross-project investigations on etiology and prevention of opioid misuse and disorder.
• Support economic evaluation across research projects.

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Funding Institute: NIDA

The NIH HEAL Initiative’s Harm Reduction Research Network will develop studies to test the effectiveness of harm reduction strategies in different community settings to inform efforts to save lives. The research network builds on existing harm reduction research and represents the largest pool of funding from NIH to date to examine harm reduction strategies to address overdose deaths. The coordinating center at RTI will provide scientific coordination and function as the operational hub for the network’s nine research projects. The work of the network will strengthen the body of evidence for harm reduction strategies and improve the lives of people who use drugs by aiming to prevent, minimize, and eliminate the risks associated. Key responsibilities of the coordinating center include:

• Providing scientific coordination and communication
• Developing common data elements to support data harmonization
• Convening key stakeholders for community engagement
• Championing scientific dissemination and translation of evidence for research and clinical practice

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Funding Institute: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Infants born to mothers who took opioids during pregnancy often already have a physical dependence on the substances they ingested through their mothers’ bloodstreams in utero, leading to infant opioid withdrawal. Mothers may take doctor-prescribed opioids during pregnancy to reduce pain associated with a chronic condition or following an injury or a medical procedure. Mothers may also take opioids for other reasons, such as opioid misuse. The ACT NOW Longitudinal Study Consortium is conducting the Outcomes of Babies With Opioid Exposure Study, which examines the medical, neuroanatomical, neurodevelopmental, behavioral, social, and familial outcomes for infants who were exposed to opioids in utero. This study follows opioid-exposed infants for 2 years after birth to record any differences in brain development and any deficits in social or behavioral milestones compared to babies who were not exposed to opioids before birth. The study also aims to explore how specific factors—including different antenatal and postnatal exposures; severity of neonatal opioid withdrawal; maternal stress, depression, and/or parenting; and home environment—modify the effects of antenatal opioid exposure on the trajectory of brain development.

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Funding Institute: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

In collaboration with the ISPCTN and NIH ECHO Program, this weaning trial concerns infants receiving methadone or morphine as the primary treatment for NOWS. The current treatment standard reduces dosage of either of these medications by 10% at a time, and the study evaluates slightly larger reductions of 15% at a time, to allow infants with NOWS to be discharged more quickly. Trained examiners in Neonatal Intensive Care Units assess neurobehavioral development in these infants to ensure the infants are healthy before discharge. The study will also involve regular follow-up with mothers and infants to ensure maternal well-being, observe maternal-infant attachment, and assess infant neurodevelopment through 2 years of age. This currently ongoing individually randomized, parallel groups, double blind trial will thus evaluate whether an early stop weaning protocol for morphine and methadone in infants treated for NOWS can safely decrease the number of days of infant opioid treatment. Both traditional frequentist and Bayesian methods will be used to derive actionable inference from trial data to help inform future clinical practice in this area.

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