These Frequently Asked Questions relate to the NCCIH funding opportunity announcement (FOA): Clinical Trials or Observational Studies of Behavioral Interventions for Prevention of Opioid Use Disorder or Adjunct to Medication Assisted Treatment-SAMHSA Opioid STR Grants (R21/R33); RFA-AT-18-002. The application due date is January 18, 2018, by 5:00 p.m. local time of applicant organization.
Is this FOA meant to pair with one of the 2-year State Targeted Response (STR) Opioid Crisis grants?
This NCCIH Request For Applications (RFA) is set up to work with the Substance Abuse and Mental Health Services Administration (SAMHSA)-funded Opioid STR grants. These grants from SAMHSA provide funds to increase services for Opioid Use Disorder (OUD) Treatment including Medication-Assisted Treatment (MAT).
The NCCIH funding cannot fund the same services funded by the SAMHSA grant. The proposed research in the NCCIH application should not have the same aims as any SAMHSA-funded research projects.
Do I need to have a SAMHSA-funded Opioid STR grant to apply for this grant?
No. You do not need to have a SAMHSA-funded grant. This is a National Institutes of Health (NIH) funding opportunity announcement that was designed to dovetail with the SAMHSA-funded Opioid STR grants.
Does NCCIH envision that grantees will collaborate with a single organization or work across several grantees?
The grant applicants would need to work with relevant state staff within a specific state. Each grant application will be reviewed by a special review group for this set of applications, and therefore the application must follow NIH requirements, including identifying a research team with required expertise to conduct the proposed research.
As stated in the FOA, all project teams must include relevant state agency staff listed as key personnel (or as other staff on the project) to ensure adequate input from state agencies regarding study design and planned outcomes.
Who can apply for this grant? We are not a state agency, so we cannot apply under the SAMHSA announcements. Can we still apply to the NCCIH funding opportunity?
This funding opportunity is for investigators with expertise in behavioral interventions for the treatment or prevention of opioid use disorders (OUDs). Please see Section III. Eligibility Information in the funding opportunity announcement (FOA) for a complete listing of eligibility criteria. Your application would need to collaborate with a state agency/agencies who have received Opioid STR grants (see above for further information).
What is the role of the state officer on the grant and what kind of expertise would the state officer have with regards to this grant proposal?
State officials with active responsibilities for SAMHSA-funded projects may have several types of relevant expertise, such as access to state infrastructure for identifying potential subjects, access to data systems that collect relevant outcome measures, or similar responsibilities that can ensure data outcomes are relevant to the state and aid in reducing otherwise-high infrastructure costs for an individual grant.
How closely do I need to work with the SAMSHA-funded state agency?
Project teams must include relevant state agency staff as key personnel (or as other staff on the project) to ensure adequate input from state agencies to study design and planned outcomes.
Are we required to work on projects outlined in the state’s proposal or are we supposed to propose new projects?
Proposed grant applications may dovetail with the state-funded services or research (but not overlap) or may focus on OUD patient populations that are of interest to the state and relevant to this FOA.
Is the grant money coming from the state’s SAMHSA award?
No, this is an NIH funding opportunity announcement with funds coming from NCCIH. Funding for this NCCIH initiative is completely independent of the funds used for the SAMHSA projects.
What patient population can we study?
You can study people with opioid use disorders (OUDs) who are receiving Medication-Assisted Treatment (MAT). You can also study people for whom the behavioral interventions you’re investigating would be used as primary prevention (people at high risk of developing OUDs) or secondary prevention (people deemed no longer requiring MAT but at risk of relapse). This funding opportunity is not for studying pain populations who may or may not be at risk of developing OUDs.
Can individual states support multiple applications?
Yes, a state can support submission of more than one application if they appear relevant to the OUD population and the FOA. Multiple applications can be submitted by a state that has the infrastructure to support the planned research in multiple applications.
Will this FOA support medication research as an adjunct to MAT?
No, this FOA only funds behavioral research. The types of behavioral interventions for prevention of OUD or as an adjunct to Medication-Assisted Treatment (MAT) for OUD that are of interest to NCCIH for the purposes of this FOA include, but are not limited to, the following: biofeedback, cognitive behavioral therapy, guided imagery, hypnosis, meditation (e.g., mindfulness meditation), mindful techniques and multidisciplinary rehabilitation, progressive relaxation, tai chi, and yoga.
Will this fund research outside of the United States or U.S. territories?
No, this is only for the U.S. states and territories who received funding from the Opioid STR grants as part of the 21st Century Cures Act.
What do R21 and R33 mean?
This NCCIH FOA is a phased award.
The R21 phase will support the development of preliminary data; feasibility studies; case report forms and other resources necessary for the performance of the study; further development and finalization of study partnerships including signed contracts with performing clinical sites; Institutional Review Board/Data and Safety Monitoring Board approval of the trial protocol, informed consent(s), and manual of operations. All regulatory approvals should be obtained prior to the end of the R21 award.
The R33 phase will support the conduct of the research study, including training of intervention providers, comparison group providers, or other resources required for study initiation. These should be planned at the start of the R33 award to allow for the successful launch and execution of the proposed clinical study in the R33 phase. The R33 award is subject to NCCIH funding availability and scientific priorities. R33 awards will be made after administrative review with attention to the extent to which agreed upon milestones have been met.
How do I contact relevant state agency staff to collaborate?
Review the list of state grantees and description of state projects for the SAMHSA Opioid STR grants on the SAMHSA website: https://www.samhsa.gov/grants/awards/2017/TI-17-014.
If you are unable to locate contact information for the state agency staff, please contact Donna Hillman (SAMHSA) at Donna.Hillman@samhsa.hhs.gov.
Please contact NCCIH scientific program contact Dr. Robin Boineau if you have questions about your grant application and whether your proposed study is a good fit for this funding opportunity.