The purpose of this Notice of Special Interest (NOSI) is to inform NIH HEAL awardees that NHLBI and NIDA are interested in administrative supplement applications aimed to delineate the significance of sleep impairments in opioid use disorder (OUD) treatment response and recovery outcomes. The supplement aims to identify specific sleep alterations associated with OUD treatment response, sleep phenotypes linked to improved OUD outcomes, as well as the effects of medication-based and behavioral OUD treatments on sleep itself.

Investigators leading current HEAL-funded clinical trials are eligible to propose logical extensions of parent studies designed to add objective assessments of sleep during OUD treatment and recovery. HEAL investigators are encouraged to establish collaboration with sleep experts to optimize the study design and implementation of sleep measures; to ensure feasibility and efficiency of data collection and integration with the parent study protocol; and to design an analysis plan that will elucidate the interaction between sleep and OUD treatment response and recovery outcomes. Sleep and circadian measurement tools that are commonly used include polysomnography, in-home sleep apnea test devices, ambulatory monitoring (e.g. actigraphy), mobile technologies, and bioassays (e.g. melatonin, cortisol), which allow quantification of hundreds of sleep phenotypes depicting sleep duration, architecture, timing, and quality. Objective measures of sleep and/or circadian rhythms are required, but the possibility of using sleep survey instruments to enhance/supplement the data collection is not excluded.

The Supplement program aims to leverage and enhance the current HEAL investment to determine which components of sleep deficiency are most closely linked to OUD treatment and recovery outcomes, and which ones have the highest value as potential therapeutic targets to apply in OUD treatment intervention studies.

NHLBI and NIDA research interests include but are not limited to:

• Identify specific sleep impairments (e.g. sleep duration, timing, quality) associated with OUD treatment (medication-based and behavioral) response and recovery outcomes.
• Delineate whether specific OUD medications and/or behavioral treatments improve relevant sleep deficiencies (e.g. sleep duration, timing, quality, disorders).
• Identify specific sleep phenotypesthat are linked to improved OUD treatment response and recovery outcomes.
• Determine critical periods across OUD treatment trajectory when sleep is most vulnerable to impairment and most amenable to improvement.
• Examine how specific OUD medications and/or behavioral interventions impact sleep regulation across the trajectory of OUD treatment.
• Elucidate interactions between circadian rhythms and OUD treatment response and recovery outcomes.

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent:

• PA-18-591 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and PA-18-591 must be followed, with the following additions:

• Application Due Date June 1, 2020 by 5:00 PM local time of applicant organization.
• For funding consideration, applicants must include NOT-HL-20-746 in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
• Requests may be for one year of support only.
• The Research Strategy section of the application is limited to 6 pages.
• Only existing awardees of NHLBI or NIDA funded HEAL clinical trial studies are eligible to apply.
• The process for Streamlined Submissions using the eRA Commons cannot be used for this initiative

Applicants are strongly encouraged to contact their Program Officer and the program contact listed below to discuss whether the proposed Supplement is within the scope of the parent HEAL award and focused on the goals of the Supplement program. To be eligible, the parent grant on which the Supplement application is based must be an active HEAL award at the time of Supplement submission, and must have sufficient time left to complete the proposed Supplement research within the existing funding period. Supplement applications are limited to $250,000 in direct costs for 1-year. The HEAL parent study must be an intervention focused on OUD treatment response and/or recovery outcomes. Supplement applications are eligible to add sleep and/or circadian assessments to the parent study. Supplement applications that propose interventions are not responsive to this Notice.