NCCIH Research Blog

The Helping to End Addiction Long-term^SM Initiative, or NIH HEAL Initiative^SM, has released notices of two upcoming funding opportunity announcements (FOAs) to support large-scale clinical trials on sickle cell disease (SCD) pain management. The National Center for Complementary and Integrative Health (NCCIH) will lead this program with partnership of nine NIH Institutes, Centers, and Offices. The funding opportunities are expected to support up to three large-scale trials.

Sickle Cell Disease Is an Urgent Research Priority

About 100,000 Americans, primarily African Americans, have SCD, an inherited lifelong illness in which abnormally shaped red blood cells block normal blood flow, leading to serious health problems. The most common complication of SCD is pain, including severe acute pain episodes, chronic persistent pain, and neuropathic pain. Current approaches for managing SCD pain are inadequate. Often, treatment doesn’t address comorbidities that may exacerbate pain, and even after curative therapy, severe chronic pain may persist. Moreover, structural barriers, including stigma and racism, have often prevented patients from receiving optimal care.

Improving the treatment of SCD is a high priority for NIH, including NCCIH. As our strategic plan explains, studying how complementary and integrative interventions can improve pain management in specific populations—including underserved populations such as people with SCD pain—is a priority for our Center.

In July of this year, NCCIH and the National Heart, Lung, and Blood Institute co-led a virtual NIH symposium on “Approaches to Effective Therapeutic Management of Pain for People With Sickle Cell Disease.” Speakers at the symposium emphasized the need to develop a better understanding of the mechanisms of SCD pain, to improve strategies for managing it, to improve adherence to SCD pain management guidelines, and to remove barriers to care.

The FOAs Will Support Effectiveness, Pragmatic, and Implementation Trials

The upcoming FOAs, which are expected to be published in the early fall, with an application due date in the late fall, are being announced in advance to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

• As announced in NOT-AT-21-017, one FOA will be for multisite effectiveness clinical trials of multicomponent nonopioid pharmacologic and nonpharmacologic approaches for acute and/or chronic SCD pain management. Trials supported under this initiative would also address the impact of these approaches on related psychological and functional outcomes to support improved overall well-being and quality of life. The trials will be conducted within the infrastructure of the HEAL Pain Management Effectiveness Research Network.
• The other FOA, described in NOT-AT-21-018, will be for multisite pragmatic or implementation trials to inform the uptake of nonopioid pharmacologic or nonpharmacologic approaches for acute and chronic SCD pain management in health care systems that serve the SCD population. Trials supported under this initiative could also address social and structural barriers such as stigma and racial bias to SCD pain management care. The trials will be part of the Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) Network.

Both FOAs will use the UG3/UH3 activity code, a biphasic, milestone-driven cooperative agreement. The UG3 phase will fund a 1-year planning phase. The UH3 phase will provide up to 4 years of funding for clinical trial conduct. Transition from the first phase to the second will depend on successful completion of the milestones established for the first phase.

We hope many of you will be interested in responding to these funding opportunities. If you have any questions or wish to discuss the research aims of your proposed project, please contact Dr. White at della.white@nih.gov.

For More Information

Notice of Intent to Publish a Funding Opportunity Announcement for HEAL Initiative: Sickle Cell Disease Pain Management Trials Utilizing the Pain Effectiveness Research Network Cooperative Agreement (UG3/UH3, Clinical Trial Required)

Notice of Intent to Publish a Funding Opportunity Announcement for HEAL Initiative: Pragmatic and Implementation Studies for the Management of Sickle Cell Disease Pain (UG3/UH3, Clinical Trials Optional)