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# Guide on Opioid Use Disorder Trial Endpoints
- URL: https://www.fdaweb.com/guide-on-opioid-use-disorder-trial-endpoints/
- Published: 2018-08-06T12:00:00.000Z
- Updated: 2026-09-15T00:23:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142040

FDA has released a [draft guidance ](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM615743.pdf?ref=fdaweb.com)entitled “Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment.” The document addresses the clinical endpoints acceptable to demonstrate the effectiveness of such drugs. For advice on specific drug development programs, sponsors are encouraged to contact CDER’s Division of Anesthesia, Analgesia, and Addiction Products.

  
The guidance notes that previous clinical trials evaluating drug effectiveness for the disorder have used reduction in drug-taking behavior (drug use patterns)as an endpoint. “FDA accepts drug use patterns as surrogates for the benefits of abstinence from drug taking or presumed benefits of reduction of drug taking,” it says. But it says there is growing interest in expanding the primary and secondary endpoints used in such clinical trials, including outcome measures important to patients and their families, clinicians, and the public.