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The Collaboration Linking Opioid Use Disorder and Sleep ("CLOUDS") Study

Award Number: U01HL150596
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/27/2019
PERIOD OF PERFORMANCE END DATE: 08/31/2025

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The Collaboration Linking Opioid Use Disorder and Sleep ("CLOUDS") Study - PROJECT SUMMARY Opioid use disorder (OUD) is a chronic and relapsing brain disease that is characterized by loss of control over opioid use. It affects over 2 million Americans and causes one overdose death every 20-minutes. Despite effective evidence-based treatments in the form of both behavioral interventions and FDA-approved medication for addiction treatment (MAT), relapse rates are high and are associated with lack of retention in treatment and a continued cycle of illicit opioid use. Further research is urgently needed to better understand the mechanisms that contribute to ongoing illicit opioid use and poor retention in MAT and identify novel treatments. In response to RFA-HL-19-029 and its call to conduct “mechanistic studies to determine the directionality of sleep and OUD interactions in humans… and to identify new opportunities for prevention and improved therapy,” The Collaboration Linking Opioid Use Disorder and Sleep (“CLOUDS”) Study will investigate patients on MAT to elucidate potential causal mechanisms between sleep deficiency and OUD. We will conduct an observational cohort study of N= 220 patients with OUD who were recently stabilized on MAT at a large opioid treatment program in New Haven, CT. At baseline, all patients will undergo: (1) comprehensive assessments of sleep and circadian rhythmicity (i.e., polysomnography, melatonin onset/offset, wrist actigraphy, and validated sleep and circadian surveys); (2) a task-enriched functional magnetic resonance imaging (fMRI) functional connectivity protocol; (3) blood assays for measures of stress and sex hormones; (4) neuro-clinical status using validated interviews, and surveys; and (5) physical home microenvironment and psychosocial family assessments. Patients will be followed for 6 months for the primary outcome of % days of illicit opioid use. In this context, we will pursue several specific aims. Aim1: Using fMRI network analyses, test whether there are different neurocognitive connectivity patterns between patients with adequate vs. deficient sleep in brain systems involved in addiction (e.g., executive function, reward processing) and assess the extent to which these “neural fingerprints” predict ongoing opioid use. Aim 2: Evaluate the potential biologic, psychiatric, and pharmacologic mechanisms that explain the causal pathway between sleep deficiency and opioid use by analyzing the mediating effect of other selected known OUD risk factors including stress, pain, negative affect, and other substance use. Aim 3: Test the extent to which ecologic factors such as psychosocial, family, and neighborhood contextual factors associated with OUD contribute to sleep deficiency among patients in MAT. An experienced multidisciplinary team of investigators with expertise in Sleep and Circadian Medicine, Biomedical Imaging, Psychiatry, Addiction Medicine, Nursing, and Psychology will conduct this research. This proposal will fulfill a critical step towards identifying novel sleep and circadian-focused treatment approaches that may lead to improved outcomes for patients with OUD.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = -$155,460 )
2026	2024	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	National Center on Sleep Disorders Research	000	2	10/1/2025	EXTENSION WITH OR WITHOUT FUNDS	-$14,460
2026	2024	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	National Center on Sleep Disorders Research	001	2	11/17/2025	EXTENSION WITH OR WITHOUT FUNDS	-$141,000
														Subtotal = -$155,460

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	National Center on Sleep Disorders Research	001	2	3/19/2025	EXTENSION WITH OR WITHOUT FUNDS	$155,460
2025	2020	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	National Center on Sleep Disorders Research	000	1	3/19/2025	SUPPLEMENT FOR EXPANSION	-$155,460
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $141,000 )
2024	2024	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	National Center on Sleep Disorders Research	001	2	9/12/2024	EXTENSION WITH OR WITHOUT FUNDS	$141,000
2024	2019	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	National Center on Sleep Disorders Research	000	1	10/20/2023	NEW	$0
														Subtotal = $141,000

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2019	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	National Center on Sleep Disorders Research	000	1	3/6/2021	NEW	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $247,925 )
2020	2020	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	National Center on Sleep Disorders Research	001	1	9/23/2020	SUPPLEMENT FOR EXPANSION	$247,925
2020	2019	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	National Center on Sleep Disorders Research	000	1	9/10/2020	NEW	$0
														Subtotal = $247,925

Issue Date FY: 2019 ( Subtotal = $4,672,265 )
2019	2019	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	National Center on Sleep Disorders Research	000	1	9/26/2019	NEW	$4,672,265
														Subtotal = $4,672,265

Grand Total All Awards = $4,905,730

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The Collaboration Linking Opioid Use Disorder and Sleep ("CLOUDS") Study

Award Number: U01HL150596

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/27/2019

PERIOD OF PERFORMANCE END DATE: 08/31/2025

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