NCCIH Research Blog

The National Institutes of Health (NIH) Helping to End Addiction Long-term^® Initiative, or NIH HEAL Initiative^®, has released two 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 in partnership with nine NIH Institutes, Centers, and Offices (ICOs). The funding opportunities are expected to support up to three large-scale trials.

Sickle Cell Disease: A Neglected and Urgent Research Priority

About 100,000 Americans, primarily of African descent, have SCD, an inherited illness in which abnormally formed hemoglobin triggers red blood cells to become sickle shaped. In this shape, they stick to blood vessel walls, block normal blood flow to organs throughout the body, and cause serious damage. Adults with the most severe forms of SCD have an average life expectancy that is 20 to 30 years shorter than that of people without SCD. 

The most common complication of SCD is pain, including severe acute recurrent 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, racism, and limited health care access, have often prevented patients from receiving optimal care.

Improving the treatment and lives of those living with SCD is a high priority for NIH, including NCCIH. One of the primary goals of the HEAL Initiative is to understand, manage, and treat pain through innovative methods. For these FOAs, NCCIH has an interest in studying how complementary and integrative interventions can improve pain management. The areas of interest of all the participating ICOs are explained in the FOA.

Pragmatic, Implementation, Efficacy, and Effectiveness SCD Trials Are Needed

NIH published two FOAs, both with an application due date of November 21, 2022. This gives potential applicants sufficient time to develop meaningful collaborations and responsive projects.

• RFA-AT-23-001 will support multisite embedded pragmatic or implementation trials to study the effectiveness or implementation of evidence-based pharmacologic, nonpharmacologic, and/or multicomponent approaches or evidence-based guidelines for acute and/or chronic SCD pain management in health care systems that serve the SCD population.
• RFA-AT-23-002 will fund multisite efficacy or effectiveness clinical trials of pharmacologic, nonpharmacologic, and/or multicomponent approaches for acute and/or chronic SCD pain management, allowing continued opioid pain management as appropriate.

Both FOAs 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. NCCIH will host a technical assistance webinar on October 4, 2022, from 2 to 3 p.m. ET. At the webinar, NIH program and review staff will provide a comprehensive overview of the two FOAs and answer questions. You can register for the webinar online. 

If you have any additional questions or wish to discuss the research aims of your proposed project, please contact Dr. Sekai Chideya at Sekai.Chideya@nih.gov.