New measure to capture substance-related problems in substance use trials
Official title: Development and Validation of a Measure of Substance-Related Consequences: A Novel Clinical Outcome Assessment for Substance Use Disorder Trials
Funded at Mclean Hospital · NIH-11376502 · Data updated 2026-11-12
Researchers are developing a new patient-centered way to quantify the negative effects of substance use to improve trials and treatments for substance use disorders.
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Mclean Hospital NIH-funded |
| Lab location | 1 site (Belmont, United States) |
| Project start | August 1, 2025 |
| Project end | July 31, 2027 |
| Funding year | 2026 |
| Award (this year) | $346,324 |
| NIH project number | 5UG3DA062906-02 |
| Project ID | NIH-11376502 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults 21 and older with substance use disorders who are in treatment or under investigation for new treatments.
✕Less likely to help
If a patient’s primary concern is abstinence alone or if their symptoms do not align with the measure’s focus on consequences, they may derive limited benefit.
What this research studies
This project aims to create and validate an outcome measure that captures the real-world consequences of substance use, not just abstinence. It focuses on improving how trials assess meaningful impact on daily functioning and quality of life for adults with substance use disorders. The work involves developing the instrument with input from patients and clinicians, testing its reliability, and ensuring it works across different substances and treatment contexts. If successful, the measure could become a standard endpoint for future SUD trials, including those involving FDA-approved medications.
Why it matters
Potential benefit: A validated clinical outcome tool that reflects patient-important consequences could improve treatment development and patient care in substance use disorders.
How similar studies have gone: Prior efforts have shown that outcome measures focusing on patient-reported consequences can enhance sensitivity to change in SUD trials, though this specific measure is novel and validation is ongoing.
Where this research is happening
-
Mclean Hospital
Belmont, United States Active
Researchers
- Principal investigator: Mchugh, Rebecca Kathryn — Mclean Hospital
- Study coordinator: Mchugh, Rebecca Kathryn
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.