NYX-783: 50 mg dose + Oxycodone for Opioid Use Disorder (OUD)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cmhc/Cnru, New Haven, CT
Opioid Use Disorder (OUD)+1 More
Oxycodone - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
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Study 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.

Eligible Conditions

  • Opioid Use Disorder (OUD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Opioid Use Disorder (OUD)

Study Objectives

7 Primary · 7 Secondary · Reporting Duration: over 6 sessions from baseline up to 3 weeks

Week 3
Pharmacokinetic (PK) levels of study medication
Week 3
Change in Clinical Opiate Withdrawal Scale (COWS)
Change in Drug Effects Questionnaire (DEQ)
Change in Opioid Symptom Checklist (OSC)
Change in Subjective Opioid Withdrawal Scale (SOWS)
Change in Visual Analog Scale (VAS)
Change in blood pressure
Change in body temperature
Change in cardiac rate
Change in cardiac rhythm
Change in heart rate
Change in oxygenation saturation
Change in pupillary diameter
Change in respiratory rate
treatment emergent adverse events (TEAES) from Systematic Assessment for Treatment Emergent Effects (SAFTEE)

Trial Safety

Safety Progress

1 of 3

Other trials for Opioid Use Disorder (OUD)

Trial Design

3 Treatment Groups

NYX-783: 50 mg dose + Oxycodone
1 of 3
NYX-783: 150 mg dose + Oxycodone
1 of 3
Placebo + Oxycodone
1 of 3
Active Control
Non-Treatment Group

9 Total Participants · 3 Treatment Groups

Primary Treatment: NYX-783: 50 mg dose + Oxycodone · Has Placebo Group · Phase 1

NYX-783: 50 mg dose + OxycodoneActiveComparator Group · 2 Interventions: Oxycodone, NYX-783 · Intervention Types: Drug, Drug
Placebo + OxycodonePlaceboComparator Group · 3 Interventions: Oxycodone, NYX-783, Placebo · Intervention Types: Drug, Drug, Drug
NYX-783: 150 mg dose + OxycodoneActiveComparator Group · 2 Interventions: Oxycodone, NYX-783 · Intervention Types: Drug, Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: over 6 sessions from baseline up to 3 weeks
Closest Location: Cmhc/Cnru · New Haven, CT
Photo of New Haven 1Photo of New Haven 2Photo of New Haven 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Opioid Use Disorder (OUD)
0 CompletedClinical Trials

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,203 Previous Clinical Trials
5,610,470 Total Patients Enrolled
124 Trials studying Opioid Use Disorder (OUD)
4,679,298 Patients Enrolled for Opioid Use Disorder (OUD)
AptinyxIndustry Sponsor
8 Previous Clinical Trials
1,501 Total Patients Enrolled
Yale UniversityLead Sponsor
1,653 Previous Clinical Trials
20,829,955 Total Patients Enrolled
21 Trials studying Opioid Use Disorder (OUD)
15,070 Patients Enrolled for Opioid Use Disorder (OUD)
Rajita Sinha, PhDPrincipal InvestigatorYale University
13 Previous Clinical Trials
2,030 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must agree to use dual contraceptive methods during the study and refrain from donating sperm or ova during study or for 28 days after final dose of drug for ova and for 90 days after final dose of drug for sperm.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.