FOR-FD-25-009
Cooperative Agreement to Support Activities Related to Analgesics, Anesthetics, and Addiction (U01) Clinical Trials Allowed
Summary
Briefing: Anesthesia, Addiction Medicine, and Pain Medicine Research
This opportunity funds research to strengthen evidence and clinical practice across anesthesia, addiction medicine, and pain management—three interconnected fields addressing critical gaps in drug prescribing and patient outcomes. The funder seeks work that develops, disseminates, implements, and evaluates research in five highly specific areas: function as a clinical trial endpoint in chronic pain populations; outcome measures for stimulant use disorder trials; opioid clinical trials incorporating active control arms alongside placebo; neurodevelopmental outcome assessment in pediatric patients exposed to anesthesia and opioids; and living systematic reviews synthesizing preclinical evidence on anesthetic neurotoxicity. The overarching goal is to generate evidence that supports appropriate prescribing of analgesics, anesthetics, and medications for substance use disorders.
Critical requirement: Proposals must articulate a comprehensive, evidence-based plan explicitly advancing appropriate drug prescribing—this goes beyond typical research scope and is mandatory for competitiveness. Work addressing general anesthesia, addiction, or pain topics may be out-of-scope if it doesn't align with one of the five named research areas.
- Who can apply: Researchers in anesthesia, addiction medicine, pain management, and related clinical/translational fields; note that proposals must address one of five specific research areas and include a prescribing-advancement plan to be eligible.
- Funding & project length: Not stated.
- Award / mechanism: Not stated; multiple awards anticipated.
- Key dates: Not stated.
- Best fit for: Clinical trialists, health services researchers, and basic scientists in anesthesia/addiction/pain medicine developing endpoints, outcome measures, trial designs, or systematic evidence syntheses to inform prescribing decisions.
Insights (6)
Five Narrow Research Areas Create Hard Scope Boundaries
The program explicitly restricts funding to five specific research domains: function as endpoint, stimulant use disorder outcomes, opioid trials with active control, pediatric neurodevelopmental assessment, or living systematic review of anesthetic neurotoxicity. Proposals addressing related topics in pain, anesthesia, or addiction—but not matching these exact foci—will likely be out-of-scope regardless of quality or relevance to the broader field.
Prescribing Advancement Mandate Requires Explicit Translational Framing
Beyond the five research areas, all proposals must demonstrate a comprehensive evidence-based plan that advances appropriate prescribing of analgesia, anesthesia, and substance use disorder medications. This is a mandatory programmatic requirement, not optional context. Applicants should explicitly map their research outputs to prescribing practice change, clinical guideline development, or decision-support tools to strengthen competitiveness.
Living Systematic Review Track Offers Lower Barrier Entry for Methodologists
The living systematic review of anesthetic neurotoxicity is a distinct pathway that may favor researchers with systematic review and evidence synthesis expertise rather than primary data generation. This track could be strategically advantageous for methodologists or evidence synthesis specialists seeking to contribute to this priority area without requiring novel clinical trial infrastructure.
Opioid Active-Control Trials Likely Require Clinical Trial Partnerships
The opioid clinical trials research area specifically mandates active-control designs (not placebo-only), which is methodologically complex and typically requires partnerships with clinical sites, trial networks, or pharmaceutical collaborators. Solo applicants without established trial infrastructure may face competitive disadvantage in this track.
Pediatric Neurodevelopmental Track May Favor Established Clinical Researchers
Research on neurodevelopmental outcomes in pediatric patients exposed to anesthesia and opioids requires longitudinal follow-up, vulnerable population protections, and institutional clinical relationships. Early-stage investigators without prior pediatric cohort access or longitudinal study experience may find this track more challenging than others.
Multiple Awards Signal Moderate Competition but Narrow Scope Limits Pool
The program states 'multiple awards may be considered,' suggesting more than one grant will be funded. However, the five highly specific research areas substantially narrow the eligible applicant pool compared to broader pain or addiction programs, potentially moderating competition intensity within each track.
Key Facts
Deadline
—
Posted
Wed, August 14, 2024
Award Range
$2,000,000 – $2,000,000
Expected Awards
5
Keywords
Research Areas
Gotchas (2)
Applicants must propose a comprehensive evidence-based plan that advances appropriate prescribing of drug products—this is a mandatory programmatic requirement that goes beyond typical research scope
85%
Source Text
“Applicants must propose a comprehensive evidence-based plan that advances appropriate prescribing of drug products intended for analgesia, anesthesia, and substance use disorders.”
Research must address one or more of five highly specific research areas (function as endpoint, stimulant use disorder outcomes, opioid trials with active control, pediatric neurodevelopmental assessm
90%
Source Text
“Specifically, research is needed in the following fields: function as a clinical trial endpoint and measurement of function in patients with chronic pain, outcome measures for clinical trials in stimulant use disorders, assessment of opioid clinical trials with active control in addition to placebo, neurodevelopmental outcome assessment of vulnerable pediatric patients exposed to anesthesia and opioid, and a living systematic review of pre-clinical studies of anesthetic neurotoxicity.”