HEAL Initiative: Sleep Predictors of Opioid-Use Disorder Treatment Outcomes Program (R01 Clinical Trial Optional)

Background
The HEAL Initiative: Sleep Predictors of Opioid-Use Disorder Treatment Outcomes Program aims to uncover novel mechanisms underlying the bidirectional interrelationship between sleep/circadian rhythm and OUD, and to reveal new insights into sleep and/or circadian-based predictors of OUD medication treatment response and outcomes. This program is part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis.

Grant Details
The program will consist of clinical Research Centers (RCs) and one Leadership and Data and Coordinating Center (LDCC). The clinical RCs will propose site-specific research projects aimed at elucidating sleep and/or circadian-based mechanisms of OUD susceptibility and/or resilience, trajectory, treatment response, and/or the effect of OUD medications on sleep and circadian regulation itself. Each clinical RC will be expected to enroll subjects for sleep-wake and circadian phenotyping that will contribute to a multi-site common protocol aimed at developing a predictive model of OUD medication treatment outcomes that incorporate sleep and circadian-based measures.

The LDCC will lead the data science driven study to develop a predictive model of OUD medication treatment outcomes based upon sleep and circadian phenotypes collected across clinical RCs.

Eligibility Requirements
Eligible applicants include higher education institutions, nonprofits, for-profit organizations, state governments, county governments, city or township governments, special district governments, Indian/Native American Tribal Governments (Federally Recognized), U.S. Territory or Possession, independent school districts, public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), faith-based or community-based organizations. Foreign Institutions are not eligible to apply.

Period of Performance
The maximum project period is four years.

Grant Value
HEAL intends to commit $20M to fund up to 5 awards across this and the companion FOA. Application budget for the site-specific projects will be limited to a total of $3M in direct costs.