Notice of Intent to Publish a Funding Opportunity Announcement for Clinical Research on Sleep and Circadian-Dependent Mechanisms Contributing to Opiate Use Disorder (OUD) and Response to Medication Assisted Treatment (MAT) - (U01 Clinical Trial Optional)

Notice Number: NOT-HL-18-655

Key Dates

Release Date: October 17, 2018
Estimated Publication Date of Funding Opportunity Announcement: November 21, 2018
First Estimated Application Due Date: February 28, 2019
Earliest Estimated Award Date: September 30, 2019
Earliest Estimated Start Date: September 30, 2019

Related Announcements

Issued by
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Drug Abuse (NIDA)


The purpose of this Notice is to inform potential applicants that the National Heart, Lung, and Blood Institute (NHLBI) and National Institute on Drug Abuse (NIDA) intend to publish a new Funding Opportunity Announcement (FOA) that will support clinical research to elucidate mechanistic interactions between sleep and circadian activity and opioid use that impact on vulnerability to opioid use disorder.

This Notice is being provided to allow potential applicants time to develop necessary collaborations and appropriate applications. The FOA is expected to be published in November 2018, with an expected application due date in February 2019.

This FOA will utilize the U01 (Clinical Trial Optional) activity code and will be an RFA. Details of the planned FOA are provided below.

Research Initiative Details

The intended FOA will invite applications using clinical research approaches to elucidate the role of sleep and circadian mechanisms in opioid use disorder (OUD), particularly mechanisms that determine the severity of physical dependence, addiction, propensity to relapse and mechanisms that modify responses to medication-assisted therapy (MAT). Identifying mechanisms by which sleep, and circadian activity contributes to these aspects of OUD and conversely how sleep and circadian rhythm are affected during the trajectory of opioid use and recovery addresses a knowledge gap and presents new opportunities to improve therapy and outcome. Multi-disciplinary, multiple-investigator teams of researchers combining expertise in clinical research, mechanisms of sleep and circadian rhythms, the neurobiology of OUD and neuropharmacology of MAT are strongly encouraged.

This FOA is only open to the study of OUD relevant mechanisms and pathobiology. Only NIH-defined clinical trials designed to elucidate mechanisms of action closely-coupled to well-recognized OUD/MAT outcomes will be supported. Highly responsive applications will identify critical mechanistic questions in understanding the role of sleep and circadian mechanisms in OUD and MAT and propose the clinical studies needed to discover answers. Evaluating the efficacy of one or more interventions without a rigorous mechanistic study design should not be proposed. Projects developed for this program must contribute significantly to the NIH HEAL (Helping to End Addiction Long-term) Initiative, an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. The study of other drugs of abuse will not be responsive.

Funding Information

Estimated Total Funding The NHLBI intends to commit total costs up to $4,000,000 in fiscal year 2019.
Expected Number of Awards The NHLBI intends to support up to 3 awards in fiscal year 2019.
Estimated Award Ceiling Application budget direct costs may not exceed $750,000 per year.
Primary CFDA Numbers 93.233, 93.837, 93.838, 93.839, 93.279

Anticipated Eligible Organizations

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
City or township governments
Special district governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Regional Organization
Applications are not being solicited at this time.


Please direct all inquiries to:

Aaron D. Laposky, PhD
National Heart, Lung, and Blood Institute