R01DA059469

Investigating mechanisms underpinning outcomes in people on opioid agonist treatment for OUD: disentangling sleep and circadian rhythm influences on craving and emotion regulation - project summary/abstract.

The US opioid epidemic costs over $1.5T and over 75,000 deaths annually. An understudied risk factor for opioid use disorder (OUD) and its treatment is the importance of sleep and circadian rhythms (CR). Opioids impact sleep quality in a fashion that inhibits recovery, and sleep remains a critical factor even when patients enter treatment: the two most efficacious medications for OUD (MOUD) also cause sleep problems that contribute to suboptimal outcomes.

To address the enormous costs of the opioid epidemic, it is essential to understand the mechanisms underlying the relationship between MOUD, poor sleep, and negative outcomes. Thus, our central hypothesis is that examination of sleep and circadian phenotypes will help to identify individuals on MOUD who will benefit from specific interventions.

Characterization of the bidirectional interplay between sleep behaviors, sleep architecture, circadian rhythms, and neurocognitive measures in individuals on MOUD is a crucial first step in identifying potential mechanisms or modifiable variables to improve MOUD outcomes. Identifying the specific type of sleep/circadian disruption by MOUD may highlight adjunctive treatment options to address the relevant sleep problem (e.g., cognitive behavioral therapy for insomnia).

Moreover, MOUDs disrupt sleep, but it is not known whether this is via alterations of CR or alterations of sleep behavior/architecture. Sleep/CR science provides experimental methods for separating circadian timing from sleep physiology in the form of the 90-minute day.

Prior work highlights neurocognitive phenotypes, craving and emotion regulation (ER), that are critical for successful MOUD outcomes. Cravings are both an OUD symptom and frequent predictor of relapse. Sleep quality affects craving possibly through positive and negative affect, emphasizing that ER is of critical concern with MOUD, as patients report an inability to regulate emotions as a primary motivation for use and for relapse. Poor sleep is associated with diminished ER.

In 100 individuals on MOUD, we will:
1) Evaluate (a) naturally occurring sleep patterns using activity monitoring for one week and (b) sleep physiology through polysomnographic recording in the sleep lab to contribute to the common aim across research sites and to provide descriptive analyses;
2) Examine sleep and circadian phenotypes using variables collected via actigraphy, PSG, and the 90-minute day protocol to examine associations of these phenotypes with neurocognitive mechanisms that may impact outcome of OUD treatment including craving and emotion regulation; and
3) Use qualitative methods to investigate the acceptability, feasibility, and perceived utility of interventions targeting the specific mechanistic relationships hypothesized.

In summary, we plan a comprehensive examination of novel pathways between sleep/circadian rhythms and neurocognitive factors —craving and emotion regulation—critical to success in MOUD as putative mechanisms underpinning the association of poor sleep and suboptimal treatment outcomes.

Emma Pendleton Bradley Hospital

TO SUPPORT BASIC AND CLINICAL NEUROSCIENCE, BIOMEDICAL, BEHAVIORAL AND SOCIAL SCIENCE, EPIDEMIOLOGIC, HEALTH SERVICES AND HEALTH DISPARITY RESEARCH. TO DEVELOP NEW KNOWLEDGE AND APPROACHES RELATED TO THE PREVENTION, DIAGNOSIS, TREATMENT, ETIOLOGY, AND CONSEQUENCES OF DRUG ABUSE AND ADDICTION, INCLUDING HIV/AIDS. TO SUPPORT RESEARCH TRAINING AND RESEARCH SCIENTIST DEVELOPMENT. TO SUPPORT DISSEMINATION OF RESEARCH FINDINGS. SMALL BUSINESS INNOVATION RESEARCH (SBIR) LEGISLATION IS INTENDED TO EXPAND AND IMPROVE THE SBIR PROGRAMS TO EMPHASIZE AND INCREASE PRIVATE SECTOR COMMERCIALIZATION OF TECHNOLOGY DEVELOPED THROUGH FEDERAL SBIR RESEARCH AND DEVELOPMENT, INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN THE SBIR PROGRAM. THE LEGISLATION INTENDS THAT THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.279 - Drug Abuse and Addiction Research Programs

National Institute on Drug Abuse (NIDA) [HHS - NIH]

Riverside, Rhode Island 029155061 United States

Single Zip Code

HEAL Initiative: Sleep Predictors of Opioid-Use Disorder Treatment Outcomes Program (R01 Clinical Trial Optional) (RFA-DA-23-059)

Amendment Since initial award the total obligations have increased 174% from $1,184,141 to $3,245,619.