Funded Projects

NOFO Title: HEAL Initiative: America?s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
NOFO Number: RFA-DA-19-019
Summary:

One novel approach to address the opioid crisis is predicting the likelihood of retention in treatment for opioid use disorder (OUD) by assessing someone?s risk of early departure from treatment. Current methods rely on providers intuition to identify when an individual is at risk of leaving treatment early in order to intervene. This intervention, when it happens, often comes too late. Mobile health (mHealth) and Machine Learning (ML) predictive analytics offer a new opportunity to personalize OUD treatment, improve retention in OUD care, and mitigate the risk of relapse and overdose episodes. Project Motivate will combine physiological and behavioral data from disparate sources in order to predict when an individual is at risk of early departure from OUD treatment. If successful, results of the study will save lives, and lower medical costs, municipal emergency response costs, recidivism, workplace accidents, lost workplace productivity and costs to families.

NOFO Title: Notice of Special Interest: HEAL Supplements to Improve the Treatment and Management of Common Co-occurring Conditions and Suicide Risk in People Affected by the Opioid Crisis
NOFO Number: NOT-MH-20-025
Summary:

The project will apply natural language processing to a rich repository of suicide and other clinical electronic health record and vital statistics to detect opioid problem-related encounters in order to (1) explore the relation between suicide risk and opioid misuse and (2) test whether a Zero Suicide model?s intervention effect is moderated by opioid misuse and whether it can also help to reduce opioid-related harm. First, the team will extract opioid-related EHR data using a combination of diagnostic codes and natural language processing, validated by structured manual chart review using a standardized procedure. Next, they will analyze the interplay between suicide risk and opioid problems in encounters and patients within the repository. Third, they will assess the effect of Zero Suicide implementation on prospective fatal and non-fatal suicidal behavior in patients with an opioid problem and examine whether the implementation had an effect on the incidence of opioid-related outcomes, including intentional overdose.

NOFO Title: Notice of Special Interest: HEAL Supplements to Improve the Treatment and Management of Common Co-occurring Conditions and Suicide Risk in People Affected by the Opioid Crisis
NOFO Number: NOT-MH-20-025
Summary:

The United States is in the middle of two intertwined epidemics. Suicide and overdose deaths are at record levels. Opioid use disorder and mental illness are major contributors to both, with the highest death rates seen in people with co-occurring disorders (COD). This competitive revision tests whether enhancements to the collaborative care (CC) model adapted for co-occurring disorders improves retention in medication treatment and decreases suicide and overdose risk. The three additional components include: (1) education of family members about addiction and medication treatment; (2) training for family members to administer naloxone and on how to reduce opioid risk behaviors, and (3) implementation of Caring Contacts, a suicide prevention intervention. This study will examine patient and family member attitudes toward overdose education and naloxone in the population with COD; examine and then intervene with family members around patients? use of medication; and test in the COD population the effectiveness of universal suicide and overdose prevention programs.

NOFO Title: Notice of Special Interest: HEAL Supplements to Improve the Treatment and Management of Common Co-occurring Conditions and Suicide Risk in People Affected by the Opioid Crisis
NOFO Number: NOT-MH-20-025
Summary:

People with opioid use disorders (OUD) have high rates of co-occurring alcohol, stimulant and other drug disorders, as well as mental disorders. Traditionally, treatment for OUD has been ?siloed? even though these high rates of co-occurring conditions emphasize the need for comprehensive treatment to address holistic needs. As the opioid crisis continues, attention to the whole person and access to comprehensive mental health and substance use treatment as well as primary care is needed. This study aims to better understand co-occurring mental health disorders, alcohol use disorders, and/or other substance use disorders among people with OUD, in the context of innovative integrated care networks for people with OUD. This study examines how innovative OUD treatment models work for individuals with co-occurring mental health and substance use by 1) assessing mental health treatment quality measures and outcomes; 2) testing how these innovative treatment models compare to other OUD treatment for people who have OUD and other substance use disorders; and 3) considering the ways people with OUD access co-occurring disorder care. The findings from this study will provide needed information to improve mental health, alcohol, and other substance use treatment for individuals with OUD, whether or not they are in OUD treatment and may provide information to help move the system from siloed efforts to truly integrated care

NOFO Title: Notice of Special Interest: HEAL Supplements to Improve the Treatment and Management of Common Co-occurring Conditions and Suicide Risk in People Affected by the Opioid Crisis
NOFO Number: NOT-MH-20-025
Summary:

This study will evaluate the implementation of the Zero Suicide framework across six health systems serving over nine million people in collaboration with the Mental Health Research Network. The project will incorporate the voice of the patient and provider stakeholders as part of the implementation of the Zero Suicide framework in three health settings from the NIMH-funded parent award as well as the Southcentral Foundation which is an Alaska Native-owned, nonprofit health care organization serving nearly 65,000 American Indian/Alaskan Native people living in and around Anchorage, Alaska. The team will first systematically engage patients, providers, national consumer advocacy groups, and MHRN scientists in formulating research questions to address the prevention of opioid-related overdoses in people with Opioid Use Disorders (OUD) or people without diagnosed OUD who are using opioids for pain management. Next, the team will utilize semi-structured interviews to determine how people with OUD or people without diagnosed OUD who are using opioids for pain management are experiencing the implementation of the Zero Suicide framework in four diverse health systems. Experiences will be recorded using 80 semi-structured phone interviews in a diverse sample of patients who have survived an opioid-related overdose (50% intentional; 50% unintentional), as well as 20 Addiction Medicine, Primary Care, and/or Specialty Pain Medicine providers.

NOFO Title: Notice of Special Interest: HEAL Supplements to Improve the Treatment and Management of Common Co-occurring Conditions and Suicide Risk in People Affected by the Opioid Crisis
NOFO Number: NOT-MH-20-025
Summary:

Homeless youth have high rates of alcohol and drug use, comorbid mental health conditions, and are at high risk for suicide. However, few preventive interventions have been proven for reducing substance use or addressing suicide among homeless youth. Resolution of youth homelessness through housing and prevention services, often referred to as ?Housing First? (HF), will be tested in the HOME (Housing, Opportunities, Motivation and Engagement) study, which aims to reduce opioid use and progression to opioid use disorder (OUD). This study will include suicide screening, treatment, education and prevention (STEP) to the model to examine whether HF provides secondary benefits for reducing suicidal ideation and behaviors among high risk homeless youth. STEP includes ongoing suicide screening procedures and Cognitive Therapy for Suicide Prevention (CTSP) for those at high risk for suicide. Youth (N=240) will be randomly assigned to receive HF + STEP + opioid and related risk prevention services (strengths-based outreach and advocacy; HIV Prevention; and motivational Interviewing) or to receive STEP + opioid and related risk prevention services, alone. Results from this study will inform the design and implementation of other national models of HF to address prevention of substance use and suicidal ideation and behaviors among homeless youth.

NOFO Title: HEAL Initiative: Effectiveness Trials to Optimize, Implement, Scale, and Sustain the Collaborative Care Model for Individuals with Opioid Use Disorders and Mental Health Conditions (U01 Clinical Trial Required)
NOFO Number: RFA-MH-19-525
Summary:

Some medications for opioid use disorder (MOUD) can be provided in primary care (PC). Systems of team-based PC show promise for improving access and retention in OUD treatment. One such model, collaborative care (CC), includes a care manager, supervised by experts, who help provide evidence-based high-quality OUD care. While CC improves outcomes of depression, other mental health and substance use (MH/SU) disorders and pain, it is unknown how to optimally integrate CC for OUD with other MH/SU disorders. This pragmatic trial tests whether our model of CC for OUD and comorbid conditions increases engagement in MOUD treatment and improves depression symptoms in PC patients with OUD and depression. Innovative pragmatic elements include inclusion of all eligible patients in participating PC clinics, random recruitment and consent, and measurement of main outcomes using only secondary data. These pragmatic elements avoid studying only motivated patients and avoid activating patients randomized to usual care.

NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

The Family School Partnership (FSP) and classroom-centered (CC) interventions targeted aggressive-coercive behavior and poor academic achievement as antecedents of the distal outcomes of antisocial behavior, substance abuse/dependence, psychiatric symptoms/disorders, high-risk sexual behavior and successful adaptation to the relevant developmental demands of the educational, work, romantic relationships and family (both family of procreation and origin/orientation) social fields/contexts. The participants of the FSP and CC original prevention trial were a population (n = 798) of urban, predominately African-American young adults, who began first grade in the fall of 1993 in nine elementary schools in predominantly low- to lower-middle-income Baltimore areas. The central purpose of the proposed study is to extend through ages 31-35 an examination of normal and pathogenic development and the impact of these two universal first-grade preventive interventions on the distal targets mentioned above. We will continue to study the role of phenotypic and genetic factors (and their interactions) as well as the impact of the interventions on the development and course of substance use/abuse/dependence, psychiatric symptoms/disorders, antisocial behavior/disorder and high-risk sexual behavior through young adulthood. The knowledge accrued over the course of the proposed assessments should serve to inform the nature, targets and timing of our future preventive intervention efforts.

NOFO Title: Interventions for Youth who Misuse/Abuse Prescription Stimulant Medications in High School and/or College-Attending Youth (U01)
NOFO Number: RFA-DA-15-010

NOFO Title: The National Drug Abuse Treatment Clinical Trials Network (UG1)
NOFO Number: RFA-DA-15-008
Summary:

According to SAMHSA’s 2017 National Survey on Drug Use and Health (NSDUH), 11.4 million persons in the U.S. report past-year opioid misuse; out of them, only 2.1 million individuals met criteria for an OUD. Very little is known about efficacious interventions for those who do not meet criteria for moderate/severe OUD (i.e., subthreshold OUD). The prevalence of subthreshold OUD in primary care settings is 5 percent to 10 percent, with higher rates (21 percent to 29 percent) among those receiving prescribed opioids. Although they are at high risk of developing moderate/severe OUD and/or dying from an overdose, little or no empirical evidence exists for pragmatic prevention interventions that can be adopted at integrated general medical settings. To study the efficacy of prevention interventions to arrest the progression from risky opioid use, researchers will test the efficacy of a STOP intervention in primary care settings. STOP adopts an early intervention approach, based on a collaborative care model to prevent progression to moderate/severe OUD, and consists of a practice-embedded nurse care manager who provides patient education and supports the primary care provider (PCP) in engaging, monitoring and guiding patients who have risky opioid use; brief advice delivered to patients by their PCP; and phone counseling of patients by behavioral health providers to motivate and support behavior change. Researchers will determine whether STOP reduces risky opioid use and examine the impact of STOP on progression to moderate/severe OUD, overdose risk behavior and overdose events in adults with risky use of illicit or prescription opioids.

NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

This supplement supports the goals of the current award, “An Evaluation of the National Zero Suicide Model Across Learning Healthcare Systems” (U01MH114087). Safety planning is a highly recommended practice within the Zero Suicide framework, but little is known about the effectiveness of the individual elements that can make up a safety plan, such as lethal means assessment, identification of supportive contacts, coping skills, warning signs, and sources of distraction. All of the documentation lives in text-based clinical narratives. This supplement will support development of new metrics using natural language processing to determine baseline rates, from which we can quantify the change in safety planning and lethal means assessment practice longitudinally after implementation of new safety planning templates using our Zero Suicide main award.

NOFO Title: HEAL Initiative: Sleep and Circadian-Dependent Mechanisms Contributing to Opiate Use Disorder (OUD) and Response to Medication Assisted Treatment (MAT) (R01 - Clinical Trial Not Allowed)
NOFO Number: RFA-HL-19-028
Summary:

Profound sleep disturbances during abstinence have long been suspected of perpetuating vulnerability to relapse of people who misuse or are addicted to opioids. An animal model has shown that long-term sleep deficiency results in a persistent state of physiological dysregulation that is expected to modify the biology of abstinence and increase relapse potential. This study seeks to discover how persistent sleep restriction during withdrawal from opioid use increases vulnerability to relapse in the animal model by testing whether persistent sleep restriction during abstinence from opioid use is sufficient to increase opioid drug seeking. The functional outcome measure will be the degree of mitigation of opioid seeking. These studies will provide a basis for novel translational approaches to target mechanisms that are demonstrated to cause increased vulnerability to relapse.