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Safety, Tolerability and Pharmacokinetics of NYX-783 and Oxycodone DDI Study

Opioid Use Disorder Clinical Trial

Official title:
Clinical Evaluation of NMDA Modulator NYX-783 for OUD: Randomized, Double-blind, Placebo-Controlled Study to Assess Safety, Tolerability, and Pharmacokinetics of NYX-783 in Combination With Oxycodone (Study 1)

Clinical Trial Summary

This study proposes to examine the safety, tolerability, and pharmacokinetics (PK) of NYX-783 50 mg and 150 mg versus Placebo (PBO) in combination with acute Oxycodone 15 mg and 30 mg in an inpatient randomized, cross-over study in non-treatment seeking non-dependent, opioid experienced individuals with current recreational use.

Clinical Trial Description

Outcomes will be cardiovascular (ECG monitoring, heart rate, blood pressure), respiratory, Clinical Opioid Withdrawal Scale (COWS), treatment emergent adverse events (TEAEs), and PK of NYX-783 levels in combination with Oxycodone. Secondary outcomes will be drug effects, subjective opiate withdrawal scale (SOWS), Drug Effects Questionnaire (DEQ), pupillary diameter, the Opioid Symptom Checklist (OSC), craving, stress and pain, and study drug levels during NYX-783 and Oxycodone combination challenge sessions. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05447286
Study type Interventional
Source Yale University
Contact Rajita Sinha, PhD
Phone 203-737-5805
Email rajita.sinha@yale.edu
Status Recruiting
Phase Phase 1
Start date May 15, 2023
Completion date October 31, 2024
View Details
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