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NYX-783 + Oxycodone for Opioid Use Disorder
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.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
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- 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.
- 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.
- Group 1: NYX-783: 150 mg dose + Oxycodone
- Group 2: Placebo + Oxycodone
- Group 3: NYX-783: 50 mg dose + Oxycodone
- 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.
Frequently Asked Questions
Are there vacancies in the present medical experiment for participants?
"As is evidenced on clinicaltrials.gov, this medical investigation is not currently accepting any more patients into the study. This trial was initially announced October 1st 2022 and last modified August 24th 2022; however, there are 291 other research initiatives that actively seek participants at present."
Which individuals would be eligible to participate in this experiment?
"The study is open to 9 individuals aged 21-50 with an opioid use disorder. Prerequisites for participation include: a commitment to dual contraceptive methods, body mass index less than 35, voluntary written consent, evidence of opiate consumption in their urine toxicology tests, full scale and verbal IQs above 80 as established by the Shipley Institute of Living IQ Screening Test., no need for medical detoxification from opioids over the past 12 months., understanding and abidance of trial regulations including providing contact information for another person if they cannot be reached."
What objectives are the researchers trying to attain with this research?
"This trial has a 6-session assessment period which will span 3 weeks, with the primary outcome being Change in body temperature. The secondary outcomes include Change in Visual Analog Scale (VAS), Change in Opioid Symptom Checklist (OSC) and treatment emergent adverse events observed via Systematic Assessment for Treatment Emergent Effects (SAFTEE). VAS assesses drug effects and craving through 5 questions, while OSC is composed of 13 true/false queries regarding opioid impact on the subject's skin. Lastly, SAFTEE evaluates somatic, behavioural and affective symptoms to tabulate TEAEs severity."
Has the combination dose of NYX-783 and Oxycodone been authorized by the Food and Drug Administration?
"Taking into account the limited evidence of safety and efficacy, our team at Power assigned NYX-783: 50 mg dose + Oxycodone a score of 1."
Is the eligibility criterion for this research project restricted to participants aged 18 and over?
"Eligible patients for this medical study must be between the ages of 21 and 50."
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