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NYX-783 + Oxycodone for Opioid Use Disorder
Phase 1
Recruiting
Led By Rajita Sinha, PhD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over 6 sessions from baseline up to 3 weeks
Awards & highlights
Study Summary
This trial will study the safety and how well participants tolerate a new drug, NYX-783, when used with oxycodone. It will also study how the new drug affects the body.
Who is the study for?
This trial is for non-dependent, opioid-experienced adults with a BMI under 35 who occasionally use opioids recreationally. They must not be seeking treatment and have no history of severe substance abuse or certain mental health conditions. Participants need to agree to contraception during the study and cannot have significant medical issues like uncontrolled diabetes, hypertension, or recent severe COVID-19.Check my eligibility
What is being tested?
The trial is testing the safety and how the body processes NYX-783 in different doses when taken with Oxycodone versus a placebo. It's an inpatient study where participants will receive treatments in a random order across different sessions to compare effects.See study design
What are the potential side effects?
Possible side effects may include typical opioid-related symptoms such as drowsiness, nausea, constipation, and risk of dependency. NYX-783 could potentially cause similar side effects due to its action on similar brain receptors.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ over 6 sessions from baseline up to 3 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over 6 sessions from baseline up to 3 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in blood pressure
Change in body temperature
Change in cardiac rate
+4 moreSecondary outcome measures
Change in Clinical Opiate Withdrawal Scale (COWS)
Change in Drug Effects Questionnaire (DEQ)
Change in Opioid Symptom Checklist (OSC)
+4 moreOther outcome measures
Pharmacokinetic (PK) levels of study medication
Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: NYX-783: 150 mg dose + OxycodoneActive Control2 Interventions
Participants will receive NYX-783 150 mg dose with + 15 mg oxycodone then NYX-783 150 mg + 30 mg oxycodone in separate inpatient randomized sessions in this, cross-over study over 6 experimental sessions.
Group II: NYX-783: 50 mg dose + OxycodoneActive Control2 Interventions
Participants will receive NYX-783 50 mg dose with + 15 mg oxycodone then NYX-783 50 mg + 30 mg oxycodone in separate inpatient randomized sessions in this, cross-over study over 6 experimental sessions.
Group III: Placebo + OxycodonePlacebo Group3 Interventions
Participants will receive placebo with + 15 mg oxycodone then placebo + 30 mg oxycodone in separate inpatient randomized sessions in this, cross-over study over 6 experimental sessions.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Opioid Use Disorder (OUD) include methadone, buprenorphine, and naltrexone. Methadone is a full opioid agonist that reduces withdrawal symptoms and cravings by activating opioid receptors in the brain.
Buprenorphine is a partial opioid agonist that also alleviates withdrawal symptoms and cravings but with a ceiling effect that reduces the risk of misuse. Naltrexone is an opioid antagonist that blocks the effects of opioids, preventing the euphoric and sedative effects.
These treatments are crucial for OUD patients as they help manage withdrawal symptoms, reduce cravings, and prevent relapse. NMDA receptor modulators like NYX-783 are being studied for their potential to modulate glutamatergic transmission, which may help in reducing opioid cravings and withdrawal symptoms, offering a novel approach to OUD treatment.
Estrogens as arbiters of sex-specific and reproductive cycle-dependent opioid analgesic mechanisms.Neoclerodanes as atypical opioid receptor ligands.
Estrogens as arbiters of sex-specific and reproductive cycle-dependent opioid analgesic mechanisms.Neoclerodanes as atypical opioid receptor ligands.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,870 Previous Clinical Trials
2,743,014 Total Patients Enrolled
AptinyxIndustry Sponsor
8 Previous Clinical Trials
1,325 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,496 Previous Clinical Trials
2,623,896 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My thyroid condition is under control with medication.My kidney function is reduced, or I have a history of kidney disease.My heart's electrical activity (QTcF) is within normal limits.I have had GI surgery affecting how I absorb medication, except for appendectomy or hernia repair.I am not on any medication that could interfere with the study.I have a history of a brain disorder like Huntington's, Parkinson's, Alzheimer's, or MS.I am not allergic to drugs like ketamine or memantine and haven't taken them in the last 60 days.I have a history of seizures.I have had a traumatic brain injury with loss of consciousness.I didn't feel much stronger effects from the initial oxycodone test.I was diagnosed with a major mental health condition like depression or bipolar disorder in the last 6 months.I occasionally use opioids without addiction, needing detox, or recent overdose.I am not pregnant or nursing.I have liver problems with high levels of certain liver enzymes.I have previously taken NYX-783.I have a family history or personal history of long QT syndrome, arrhythmias, or heart disease.I have had COVID-19 or symptoms of it in the last 2 months.My diabetes or blood pressure is not under control.
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo + Oxycodone
- Group 2: NYX-783: 150 mg dose + Oxycodone
- Group 3: NYX-783: 50 mg dose + Oxycodone
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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