Notice of Intent to Publish a Funding Opportunity Announcement for Limited Competition: Behavioral Research to Improve MAT: Ancillary Studies to Enhance Behavioral or Social Interventions to Improve Adherence to Medication Assisted Treatment for OUD (R01)

Notice Number: NOT-AT-19-007

Key Dates

Release Date: November 02, 2018
Estimated Publication Date of Funding Opportunity Announcement: December 08, 2018
First Estimated Application Due Date: March 15, 2019
Earliest Estimated Award Date: October 15, 2019
Earliest Estimated Start Date: October 15, 2019

Related Announcements
NOT-AT-19-006

Issued by
National Center for Complementary and Integrative Health (NCCIH)

Purpose

The National Center for Complementary and Integrative Health (NCCIH), along with partnering NIH Institutes/Centers/Offices intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for research to expand research activities funded under RFA-AT-18-001RFA-AT-18-002, and RFA-DA-18-005. Expansion of research activities should increase the generalizability of findings to allow for more rapid dissemination and implementation of successful interventions. Examples of additional activities that could be supported under this FOA include, but are not limited to: adding recruitment/study sites, adding evidence-based behavioral or social interventions to studies that are currently only expanding Medication Assisted Treatment (MAT) availability or access, increasing the overall sample size, targeting under-represented populations, and allowing for longer follow-up. This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

The FOA is expected to be published in Fall 2018 with an expected application due date in Winter 2019.

This FOA will utilize the R01 activity code. Details of the planned FOA are provided below.

This study is part of the of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative will bolster research across NIH to: (1) improve treatment for opioid misuse and addiction, and (2) enhance pain management. More information about the HEAL Initiative is available at:  https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative.

Public Law 115-141, the Consolidated Appropriations Act of 2018 (signed March 23, 2018) includes a requirement that grantees from for-profit applicant organizations must provide a 50% match and/or in-kind contribution of all federally awarded dollars under the grant award (direct costs, as well as facilities and administrative costs) for research related to opioid addiction, development of opioid alternatives, pain management and addiction treatment.

Matching Requirement: A grantee from a for-profit organization funded under this funding opportunity announcement must match funds or provide documented in-kind contributions at a rate of not less than 50% of the total-Federally awarded amount, as stipulated by Public Law 115-141, the Consolidated Appropriations Act of 2018. The applicant will be required to demonstrate that matching funds and/or in-kind contributions are committed or available at the time of, and for the duration of, the award. Applications must identify the source and amount of funds proposed to meet the matching requirement and how the value for in-kind contributions was determined. All matching funds and/or in-kind contributions must be used for the portion of allowable project costs not paid by Federal funds under the grant award.  NIH will not be the recipient, nor serve as a pass-through entity, of any such matching funds and/or in-kind contributions required under this announcement.  See 45 CFR 75.306 for additional details.

Research Initiative Details

This Notice encourages investigators funded under RFA-AT-18-001RFA-AT-18-002, and RFA-DA-18-005 with expertise and insights into behavioral and social interventions to improve medication assisted treatment (MAT) to begin to consider applying for this new FOA.

 

There is an opioid crisis in the United States. More than 4 million people in the United States report using opioids for non-medical purposes in the past month, and almost 2 million report symptoms consistent with an opioid use disorder (OUD) (National Survey on Drug Use and Health [NSDUH]).  Fewer than half of those with an OUD receive treatment (Volkow et al., 2014) and even fewer receive treatment of adequate duration.  The number of drug overdose deaths involving opioids has quadrupled between 1999 and 2015, to more than 33,000 annually (Rudd et al., 2016).

While there are effective FDA-approved medications for OUD including methadone, buprenorphine/naloxone, buprenorphine, and naltrexone, there has been a lack of access and limited utilization of these treatments. The 21st Century Cures Act addresses one significant barrier: insufficient funding for medication assisted treatment (MAT). The Substance Abuse and Mental Health Services Administration (SAMHSA) released two funding opportunity announcements designed to support states' responses to the opioid crisis (TI-17-014 “State Targeted Response to the Opioid Crisis Grants”, and TI-18-020 “Opioid State Targeted Response (STR) Supplement”).

Chronic pain is an important co-morbidity in patients with OUD.  Twenty to 30 percent of US adults report chronic pain (Nahin, 2015). Treatment of acute and chronic pain conditions with opioids is contributing to this OUD epidemic. Pain patients at increased risk of developing OUD are those with pain that is inadequately controlled, exposed to opioids during acute pain episodes, and/or chronic pain in patients with a history of substance abuse.  Among patients with OUD treatment and chronic pain, barriers to patients actively engaging in treatment include fear of inadequately treated pain and depression (Stumbo et al, 2017). Several behavioral interventions have shown value for management of chronic pain. Recent American College of Physician guidelines for management of chronic back pain include recommendations to consider interventions including mindfulness-based stress reduction, multidisciplinary rehabilitation, meditative exercise such as tai chi and yoga, progressive relaxation, operant therapy and cognitive behavioral therapy (CBT) (Qaseem et al., 2017 [ACP guidelines]). Additionally, a recent systematic review on Noninvasive Nonpharmacological Treatment for Chronic Pain from the Agency for Research on Quality and Health (AHRQ) concluded, "Exercise, multidisciplinary rehabilitation, acupuncture, CBT, and mind-body practices were most consistently associated with durable slight to moderate improvements in function and pain for specific chronic pain conditions." (Skelly et al., 2018) However, there are relatively few studies evaluating their effectiveness for the comorbidity of OUD and chronic pain.

With SAMHSA's continued support of state's opioid crisis response, we invite NIH grants funded through RFA-AT-18-001, RFA-18-002, and RFA-DA-18-005 to submit research project grant (RPG) applications that will support ancillary research activities to substantially enhance and/or expand the aims of the funded parent grants.

Additional activities that may be supported by this FOA include, but are not limited to: adding evidence-based behavioral or social interventions to studies that, to date, are only expanding MAT availability or access, adding additional study sites, increasing total sample size, increase efforts to increase recruitment of under-represented populations, add additional data collection points, longer follow-up time points, and addition of new outcome measures

Funding Information

Estimated Total Funding $4,500,000 in FY2020 Enter total amount IC intends to commit to the entire Program for the FIRST YEAR for all applications and all ICs (not award ceiling). Cannot be a range.
Expected Number of Awards 8
Estimated Award Ceiling $400,000
Primary CFDA Numbers 93.213

Anticipated Eligible Organizations

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
City or township governments
Special district governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Regional Organization

Applications are not being solicited at this time.

Inquiries

Please direct all inquiries to:

Dave Clark, DrPH
National Center for Complementary and Integrative Health (NCCIH)
01-827-1916
Dave.Clark@nih.gov


NCCIH HEAL Initiatives
National Center for Complementary and Integrative Health (NCCIH)
Email: NCCIHHEAL@mail.nih.gov