Applications are invited from institutions to participate as the Leadership and Data Coordinating Center (LDCC) for the Sleep Predictors of Opioid Use Disorders (OUD) Treatment and Outcomes Program.
Donor Name: National Institutes of Health (NIH)
State: All States
County: All Counties
U.S. Territories: U.S. Virgin Islands, Commonwealth of the Northern Mariana Islands, American Samoa, Commonwealth of Puerto Rico, Guam
Type of Grant: Grant
Deadline: 01/10/2023
Size of the Grant: $1.5M
Grant Duration: 4 years
Details:
The purpose of this Funding Opportunity Announcement (FOA) is to invite institutions to participate as the Leadership and Data Coordinating Center (LDCC) for the Sleep Predictors of Opioid Use Disorder (OUD) Treatment and Outcomes Program. The overall goals of this program are a) to uncover novel mechanisms underlying the bidirectional interrelationship between sleep/circadian rhythm and OUD, and b) to delineate sleep and/or circadian-based predictors of OUD treatment response and outcomes. The Leadership and Data Coordination Center will lead, coordinate, and analyze data for a multi-site common protocol focused on sleep/circadian rhythm measures. The data will be used to develop a predictive model of OUD medication treatment response and outcomes.
While sleep deficiency is a symptom of OUD, and plausibly one of the mediating factors that contributes to opioid overuse, withdrawal, poor treatment response and relapse, approximately 70–85% of OUD patients on medications for opioid use disorder (MOUD)also report sleep disturbances. Abnormalities in sleep architecture, including deficiencies in rapid-eye movement sleep and slow-wave sleep have been reported in patients on MOUD. These disturbances persist through long-term MOUD, suggesting that they may not be attributable simply to medication adjustments common in early treatment. Sleep disturbances triggered by OUD medications may interfere with the ability of OUD medications to manage withdrawal and prevent relapse. In addition, opioids used in MOUD can change circadian rhythms, which in turn may affect the time of day of optimal drug administration.
Key activities of the LDCC related to the multi-site predictive modeling study will be to:
- Implement a data-science based research plan to delineate sleep and/or circadian-based predictors and develop a predictive model of OUD medication treatment response and outcomes. The predictive model should use objective sleep and circadian measurements including, but not limited to, EEG-based measurements that will be collected by the RCs. The LDCC should anticipate analyzing measurements from approximately 100 participants per RC for predictive modeling. The number of measurements reposited per RC may change, based upon the final multi-site protocol that is developed post award.
- Facilitate all aspects of recruitment for the multi-site study, develop consent form templates; prepare and submit IRB materials.
- Develop standard operating protocols and manual of operations; oversee site adherence to the protocol; administer protocol amendments, as needed; facilitate coordinator and staff training.
- Work with RCs to ensure that data collection procedures are harmonized; data formats are standardized; develop and assess data quality metrics; ensure data sharing plan complies with HEAL data ecosystem requirements.
- Work closely with RCs to develop analysis strategies to integrate datasets in synergistic ways with relevant data sets and to analyze the data generated.
- Archive raw and processed datasets generated by the RCs.
- Provide oversight for training and certification of research staff.
- Develop a plan for biospecimen collection, storage, and analysis, as applicable.
- Develop a website that will serve as a community-wide nexus for protocols, raw and processed data, and other resources generated by the RCs.
- Organize monthly conference calls and annual steering committee meetings.
- Propose and budget for specific services (e.g., Sleep Reading Center, biospecimen repository and/or analytics), as needed, and establish necessary sub-contracts or other funding plans.
Applications that are not responsive to this FOA will not be reviewed. To be responsive to this FOA, the major thrust of the application must be to:
- Propose a data-science based plan to delineate sleep and/or circadian-based predictors of OUD treatment response and outcomes.
- Develop and test a predictive model of OUD medication treatment outcomes using objective sleep measurements including, but not limited to, EEG-based measurements.
- Perform functions of a data coordinating center to lead, coordinate, and implement all aspects of the multi-site protocol.
Award Budget
Application budget for the LDCC will be capped at a total of $1.5M in direct costs. The proposed budget needs to reflect the actual needs of the proposed project.
Award Project Period
The maximum project period is four years.
Eligibility Information
Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education
- Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
For-Profit Organizations
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
Local Governments
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
Federal Government
- Eligible Agencies of the Federal Government
- U.S. Territory or Possession
Other
- 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
- Regional Organizations
Foreign Institutions
- Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
- Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
- Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
For more information, visit Grants.gov.
