# Development of the Opioid Use Disorder Severity Scale

> **NIH NIH U01** · YALE UNIVERSITY · 2020 · $568,625

## Abstract

7. PROJECT SUMMARY/ABSTRACT
The development of new medications to reduce the burden caused by opioid use disorder (OUD) is a high
priority in addressing the opioid crisis. However, the currently available tools and endpoints to evaluate and
approve new medications to treat opioid use is an impediment to medication development. Measures of
change in the diagnostic criteria (i.e., symptoms) of OUD have rarely been used as indicators of improvement
from treatment, despite this approach being standard practice for other psychiatric disorders. There is
preliminary evidence from multiple clinical trials that change in Diagnostic and Statistical Manual of Mental
Disorders (DSM) diagnostic threshold and criteria counts has potential utility as a clinically meaningful
outcome. However, the only validated assessments for measuring the presence and severity of DSM-5 OUD
are clinician-administered, semi-structured interviews, requiring extensive training and cost making them
impractical for broad use. In this project, we propose to develop a new clinical outcome assessment that is an
electronically-administered, patient self-report instrument directly linked to DSM-5 diagnostic criteria for
measuring the severity of OUD, the ‘Opioid Use Disorder Severity Scale’ (OUDSS).
The specific aims are to: (1) generate a pool of self-report items based on structured clinical interviews for
OUD and existing items banks of substance use disorder severity to create an electronic, self-administered
instrument directly linked to the diagnostic criteria in DSM-5; (2) evaluate the content validity and
administration procedures of the OUDSS through one-on-one qualitative interviews with 20 patients with OUD;
and (3) evaluate the reliability and validity of the OUDSS in a diverse sample of 300 individuals
seeking/enrolled in outpatient treatment to determine construct validity, test-retest reliability, and ability to
detect change.
Development and evaluation of the OUDSS will follow the FDA Guidance for Patient Reported Outcome (PRO)
measures. Because of the rigorous methods required for development of a PRO instrument, we are targeting
OUD rather than general substance use disorders for development during the period of this award. As DSM-5
diagnostic criteria are equivalent across substances of abuse, the OUDSS could be modified for other specific
substances (or substance use disorders in general) with minimal effort. A validated, easy to administer,
electronic PRO measuring OUD severity would be a significant contribution to treatment research, clinical care,
and medication development.

## Key facts

- **NIH application ID:** 10045652
- **Project number:** 1U01DA051639-01
- **Recipient organization:** YALE UNIVERSITY
- **Principal Investigator:** BRIAN D. KILUK
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $568,625
- **Award type:** 1
- **Project period:** 2020-07-01 → 2023-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10045652

## Citation

> US National Institutes of Health, RePORTER application 10045652, Development of the Opioid Use Disorder Severity Scale (1U01DA051639-01). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10045652. Licensed CC0.

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