PCORI Funding

Addressing Substance Use

A PCORI Funding Announcement (PFA) will open on May 7, 2024 to fund studies that focus on addressing substance use/misuse and substance use disorders. Substances of interest include but are not limited to alcohol, opioids, nicotine and polysubstance use. Applications may propose comparative clinical effectiveness research (CER) studies of prevention, screening, harm reduction, treatment and recovery approaches for substance use/misuse and substance use disorders at the individual, community or systems level to improve patient-centered substance-use-related outcomes. At least one primary outcome must be focused on substance use.

PCORI is particularly interested in submissions that address the following Special Areas of Emphasis (SAEs), although applicants are not limited to these areas:

• Evidence-based strategies to advance equity in the prevention and treatment of substance use disorders
• Evidence-based interventions for overdose prevention
• Strategies to reduce nicotine and tobacco use in disproportionally affected populations

Proposed studies should examine large and diverse populations with an overall sample size that will allow precision in the estimation of hypothesized effect sizes and, as appropriate, analysis of population subgroups that may include heterogeneity of treatment effects. For this funding announcement, applicants may request coverage of patient care costs (including medical products, procedures and care services) for potential funding by PCORI.

Population

PCORI is particularly interested in applications focusing on substance use/misuse and substance use disorders in high-need and/or underserved populations, including but not limited to:

• rural populations
• low-income populations
• sexual/gender minorities
• racial/ethnic minorities
• pregnant persons
• those involved with the justice system
• youth
• older adults and individuals with co-occurring mental and physical health conditions

Outcomes

Well justified substance-use-related outcomes that are clinically meaningful, considered important by those with lived experience and which can be impacted by the proposed intervention within the study duration. Objective outcome measures are encouraged where appropriate and self-report outcomes should be sufficiently justified.

Funding

• Total allocated for this PFA: Up to $100 million
• Total direct funding: Up to $12 million

Maximum project duration

Five years

Important dates

May 7 – Applications open
May 16 – Town Hall
June 4 – Letters of Intent due (please use template on application page)
September 4 – Applications due
November 2024 – Merit review
March 2025 – Awards announced
July 2025 – Earliest start date

PCORI Special Office Hours

Potential applicants can also request an opportunity to speak with PCORI staff for more complex questions during virtual “office hours.” Submit your project information and questions on the website.

Harvard Catalyst PCORI Consultation

For more information or to request a brief consultation, please contact the Harvard Catalyst PCORI Funding Specialist, Leslie MacGregor: Leslie_MacGregor@hms.harvard.edu