As part of NIH’s Helping to End Addiction Long Term (HEAL) Initiative, NIH will support competing revisions (formerly known as, competitive supplements) to improve the treatment and management of common co-occurring conditions and suicide risk in people affected by the opioid crisis. A total of $8 million is available to supplement existing grants and cooperative agreements, for up to 2 years, to evaluate strategies to improve treatment, management, and services for people with co-occurring conditions and suicide risk; measure co-occurring conditions in trial outcomes for issues related to treatment access, continuity, and response; and identify or validate putative change mechanisms that may account for secondary benefits of treatment (e.g., reduction of suicide risk as a following successful opioid use disorder [OUD] treatment) and that can inform the development and testing of future prevention, treatment, and/or services interventions. Supplement requests do not need to address all possible co-occurring conditions, but they must have clear and direct relevance to OUD and/or chronic pain.

Background

In August 2019, the HEAL Multidisciplinary Working Group (MDWG) identified that research can improve the provision of care for people with common co-occurring conditions associated with the opioid crisis (e.g., people with chronic pain, mental health disorders, suicide risk, alcohol misuse/alcohol use disorder, and/or other substance use disorders). Clinicians in settings such as primary care routinely face patients with complex needs. Workflows and services need to be in place to help the modal patient, who often presents with some combination of treatable conditions, including OUD (or OUD risk), mental health conditions, suicide risk, chronic pain, alcohol use disorder (AUD), and other substance use disorders (SUDs). Failure to adequately address co-occurring conditions may increase OUD risk and other adverse outcomes such as suicide or AUD and impede OUD treatment. Conversely, a multi-pronged strategy that addresses co-occurring conditions may yield greater improvements in OUD outcomes. The proposed research will enable investigators to evaluate the most effective OUD treatments, services, and prevention interventions for the significant number of people presenting with co-occurring mental health, pain, and alcohol, and substance use conditions and who may also be at risk for suicide.

DESCRIPTION OF RESEARCH:

As part of NIH’s HEAL Initiative, NIH will support competitive supplements to improve the treatment and management of common co-occurring conditions and suicide risk in people affected by the opioid crisis. Supplement requests need not address all possible co-occurring conditions, but to be considered for funding, they must have clear and direct relevance to OUD and/or chronic pain.

High priority supplements will:

• Evaluate strategies to improve the treatment, management, and services for people with co-occurring conditions and suicide risk;
• Measure co-occurring conditions in trial outcomes for issues related to treatment access, continuity, and response; and/or
• Identify or validate putative change mechanisms that may account for secondary benefits of treatment (e.g., reduction of suicide risk as a following successful OUD treatment) and that can inform the development and testing of future prevention, treatment, or services interventions.

Researchers interested in including measures of suicide risk may find this guidance of interest: https://www.nimh.nih.gov/funding/clinical-research/conducting-research-with-participants-at-elevated-risk-for-suicide-considerations-for-researchers.shtml

Examples of grants and cooperative agreements to be supplemented may include but are not limited to the following:

• Studies that previously included only people with OUD and now wish to include people with other substance use problems (e.g., cannabis or benzodiazepines) or alcohol use disorder to better represent the clinic population in efforts to improve treatment for OUD and/or chronic pain;
• Clinical trials that included people with non-OUD substance abuse problems but did not originally and systematically assess or treat these problems as part of the intervention(s) being tested but will be able to do so with supplemental funds;
• Clinical studies that evaluate the effect of tapering prescription opioids (initially prescribed for pain) as part of practice improvement efforts to address mental health conditions and suicide risk;
• Studies to improve case identification, treatment quality, and workflows for patients with common co-occurring conditions (e.g., mental health problems like PTSD, anxiety, or depression) or patients at high risk for suicide who would otherwise receive no intervention or be referred elsewhere;
• Trials that are interested in long term (e.g., 12-month) outcomes associated with suicide events (attempts, deaths, and rescue crisis ED/inpatient services) and nonfatal overdose (regardless of intent);
• Studies that want to add qualitative measures of family member perceptions of patient involvement in care approaches that address the assessment, interventions, and follow-up practices associated co-occurring conditions;
• Studies that intensify services or address those social determinants of health (SDOH) as intervention targets that are known to be significant contributors to health disparities;
• Studies that leverage electronic health record (EHR), claims, or other large datasets in efforts to explain, predict, or manipulate the moderating or mediating effects of treatment engagement, retention, or outcomes associated with co-occurring conditions;
• Prevention trials that can explore whether interventions that reduce common risk factors for suicide, alcohol use, and other substance use risk, also result in outcomes improvements across alcohol, OUD and other SUD conditions, and suicide risk;
• Studies that can improve access, engagement, and quality of care for people with co-occurring serious mental illness (e.g., schizophrenia, bipolar disorder, borderline personality disorder) who may have severe cognitive and functional deficits but who are also affected by the opioid epidemic and/or are experiencing chronic pain;
• Trials funded through the Clinical Trial Network (CTN) that will prioritize pain management and suicide prevention because preliminary data suggest that abrupt prescription opioid tapers may increase risk of suicide and overdose among people with pain tapering off prescription opioids. CTN study would generate empirical evidence on the effectiveness of buprenorphine for chronic pain and mental health symptom management among patients with opioid use disorder and aberrant drug taking behavior;
• Trials involving justice-involved populations that did not but will now add validated measures to assess co-occurrence of chronic pain, mental health/suicide risk, opioid, and alcohol or other substance misuse and disorders; test strategies for providing linkages to community-based services for chronic pain management; and examine the service needs and treatment outcomes of individuals with co-occurring pain and/or mental illness, and OUD;
• Studies that seek to understand and improve the quality of care for people with mental health disorders who are disproportionately prescribed pain medication, relative to the general population.

Prior to submitting, applicants are strongly encouraged to speak with both your program officer of the grant or cooperative agreement to be supplemented and the program contact from the relevant NIH institute or center (below).

Requests may be for one or two years of support.

Applications that propose supplemental data collection in on-going studies should clearly address the following: study progress, including enrollment, to date, the anticipated number of data points that can be captured with the proposed supplemental assessments, and a plan for how the newly collected data will be analyzed.

A supplement could propose to recruit participants in a separate pilot arm or sample to determine feasibility of research methods and hypotheses.

Indicate the title of this Notice, 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, in the abstract.

Requests must be received by 04/07/2020 for funding in FY 2020.

Award Information

NIH intends to commit $8 million in FY2020. Budgets should be commensurate with the project scope. Competitive revision requests to grants and cooperative agreements will be acceptedfrom any activity code, so long as the topic aligns to the priorities and examples described in this Notice of Special Interest.

Application and Submission Information

This notice applies to due dates on or after 03/05/2020 and subsequent receipt dates through 04/07/2020

Active awards with project end dates in FY 2020 or later are eligible. The award may not be in terminal no cost extension or going into a no cost extension in FY2020.

Submit applications for this initiative through the following funding opportunity announcement (FOAs) or any reissues of this announcement through the expiration date of this notice.

• Applications must be submitted to PA-18-935, Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement Clinical Trial Optional)" using the application forms package with the Competition ID NOT- MH-20-025-FORMS-E".

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include NOT-MH-20-025 (without quotation marks) 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.

Applications nonresponsive to terms of this NOSI will be not be considered for the NOSI initiative.

Please direct all inquiries to the Scientific/Research, Peer Review, and Financial/Grants Management contacts in Section VII of the listed funding opportunity announcements.

Scientific/Research Contact(s)

Michael C. Freed, Ph.D., EMT-B
National Institute of Mental Health (NIMH)
Telephone: 301-443-3747
Email: michael.freed@nih.gov

Ivana Grakalic, Ph. D.
National Institute of Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-7600
Email: igrakalic@mail.nih.gov

Laura Kwako, Ph.D.
National Institute of Alcohol Abuse and Alcoholism (NIAAA)
Telephone:301-451-8507
Email: laura.kwako@nih.gov

Amy Goldstein
National Institute of Drug Abuse (NIDA)
Telephone:301-827-4124
Email: amy.goldstein@nih.gov

Financial/Grants Management Contact(s)

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: Tamara.Kees@nih.gov

Judy Fox
National Institute of Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: jfox@mail.nih.gov

Pamela Fleming
National Institute of Drug Abuse (NIDA)
Telephone: 301-480-1159
Email: pfleming@nida.nih.gov