What side effects are associated with this type of intervention?

Common treatments for Opioid Use Disorder include medications such as methadone, buprenorphine, and naltrexone. Methadone and buprenorphine, both opioid agonists, can cause side effects like constipation, drowsiness, and potential for dependency. Naltrexone, an opioid antagonist, may lead to side effects such as nausea, headache, and dizziness. NMDA receptor modulators, like ketamine, which are being studied for OUD, can cause side effects including dissociation, hallucinations, and increased blood pressure. These treatments aim to reduce opioid cravings and withdrawal symptoms, but their side effects must be managed carefully.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Opioid Use Disorder (OUD), including methadone, buprenorphine, and naltrexone. Methadone is a full opioid agonist, buprenorphine is a partial opioid agonist, and naltrexone is an opioid antagonist. While these medications do not specifically target NMDA receptors, they are effective in managing OUD by reducing cravings and withdrawal symptoms. Research into NMDA receptor modulators like NYX-783 is ongoing, and such treatments may offer new avenues for addressing OUD in the future.

What other types of research exist?

Promising novel alternatives to NYX-783 for opioid use disorder patients include: 1) Buprenorphine/naloxone (BNX) - a combination therapy that has shown effectiveness in maintenance treatment for OUD. 2) Naltrexone - an opioid antagonist used for relapse prevention. 3) Gabapentin - has shown potential in reducing cannabis use and may have applications in OUD. 4) Sublingual buprenorphine - effective for chronic pain and OUD management. These alternatives have demonstrated efficacy in clinical trials and are viable options for OUD treatment.

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NYX-783 + Oxycodone for Opioid Use Disorder

Phase 1

Waitlist Available

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

Must not have

Creatinine clearance <60ml/min at screening or history of renal disease as assessed by Investigator

Screening QT interval corrected for heart rate (HR) by Fridericia's formula (QTcF) > 450 (males) or 470 (females) milliseconds (msec) or an ECG that is not suitable for QT measurements (e.g., poorly defined termination of T-wave in the investigator's opinion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up over 6 sessions from baseline up to 3 weeks

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Summary

This trial tests a new drug called NYX-783 with Oxycodone in people who use opioids recreationally but are not addicted. The goal is to see if the combination is safe and how it affects heart rate, blood pressure, and withdrawal symptoms.

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is reduced, or I have a history of kidney disease.

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My heart's electrical activity (QTcF) is within normal limits.

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I have had GI surgery affecting how I absorb medication, except for appendectomy or hernia repair.

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I have a history of a brain disorder like Huntington's, Parkinson's, Alzheimer's, or MS.

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I am not allergic to drugs like ketamine or memantine and haven't taken them in the last 60 days.

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I have a history of seizures.

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I have had a traumatic brain injury with loss of consciousness.

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I didn't feel much stronger effects from the initial oxycodone test.

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I am not pregnant or nursing.

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I have liver problems with high levels of certain liver enzymes.

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I have previously taken NYX-783.

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I have a family history or personal history of long QT syndrome, arrhythmias, or heart disease.

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My diabetes or blood pressure is not under control.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and over 6 sessions from baseline up to 3 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in blood pressure

Change in body temperature

Change in cardiac rate

+4 more

Secondary study objectives

Change in Clinical Opiate Withdrawal Scale (COWS)

Change in Drug Effects Questionnaire (DEQ)

Change in Opioid Symptom Checklist (OSC)

+4 more

Other study objectives

Pharmacokinetic (PK) levels of study medication

Awards & Highlights

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.

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.

0 / 13Eligibility criteria met

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.