Status:
COMPLETED
A Study to Evaluate the Abuse Potential of Oxymorphone Compared to Other Mu Opioid Agonists.
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
University of Kentucky
Conditions:
Opioid Use Disorder
Eligibility:
All Genders
21-55 years
Phase:
PHASE2
Brief Summary
Significant public health concerns have arisen from the intravenous misuse of oxymorphone, a potent mu-opioid pain medication. However, little is known about its abuse potential relative to other mu-o...
Detailed Description
Significant public health concerns have arisen from the misuse of oxymorphone, a potent mu-opioid pain medication approved by the Food and Drug Administration as Opana and Opana ER. However, little is...
Eligibility Criteria
Inclusion
- Able to understand and provide signed and dated written consent.
- Self-reported opioid use for nontherapeutic purposes on at least 21 days in the 30 days prior to screening, physical dependence on opioids, recent intravenous opioid use, and meeting DSM 5 criteria for moderate-severe opioid use disorder.
- Positive urine drug screen for opioids (those who are in a methadone or buprenorphine treatment program are ineligible; physical dependence on street methadone or buprenorphine are also exclusionary so participants must produce at least one methadone- or buprenorphine-negative urine during screening).
- ≥ 21 and ≤ 55 years of age.
- Body mass index (BMI) ≥ 18 and ≤ 35 kg/m2 and weight ≥ 50 kg (110 pounds).
- Otherwise healthy as determined by the investigator.
- Demonstrate understanding how to complete the self-administration tasks and VAS Questionnaire.
- Women of childbearing potential must not be pregnant or breastfeeding at screening.
- Willing and able to comply with all testing requirements defined in the protocol.
- participation in the Study Treatment Phase:
- During the Study Qualification Phase, on the bipolar 100--mm Drug Liking VAS, the subject must provide Emax ≥ 40 mm and \< 60 mm following placebo and, following morphine 56 mg/70 kg, i.v., Emax ≥ 60 mm and ≥ 15 mm closer to "Strong Liking" than the Emax to placebo.
- In the judgment of the investigator, the subject is able to tolerate the i.v., opioids administered in the study, including the ability to complete most pharmacodynamics assessments administered post--dose.
- In the judgment of the study staff, the subject's general behavior during the Study Qualification Phase suggests the ability to successfully complete the Study Treatment Phase.
Exclusion
- History of a medical or psychiatric disorder that would prevent successful completion of the study.
- Current DSM-5 diagnosis of substance use disorders requiring medical management other than OUD.
- Suicidal ideation or intent with or without a plan at Screening or within 6 months prior to Screening (i.e., answering "Yes" to questions 4 and/or 5 on the Suicidal Ideation section of the Columbia Suicide Severity Rating Scale).
- Currently seeking or participating in treatment for substance use disorder.
- Physically dependent on drugs of abuse (other than opioids, nicotine, or caffeine) or alcohol.
- Medically important deviation from normal limits on physical examination, vital signs, screening laboratory tests, or 12--lead ECG.
- Significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, or neurologic disorder.
- Any surgical, or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test drug.
- Family history of long QT syndrome and/or unexpected sudden cardiac death or is known to have QTc \> 500 ms at screening.
- Used an investigational agent within 30 days or 5 therapeutic half-lives of that agent, whichever is longer, prior to the first dose of study drug.
- Hypersensitivity to opioids or any drug intended for use in this study.
- Acute gastrointestinal symptoms (e.g., nausea, vomiting, fever, or Diarrhea unrelated to opioid withdrawal) ≤ 7 days before Day 1.
- Any of the following values for laboratory tests at Screening:
- A positive pregnancy test in women of childbearing potential.
- Hemoglobin \< 11 g/dL in males and \< 10 gm/dL in females.
- Neutrophil count \< 1.0 × 109/L.
- Platelet count \< 75 × 109/L.
- Creatinine clearance \< 50 ml/min per modified Cockcroft-Gault equation.
- Aspartate aminotransferase or alanine aminotransferase \> 3.0x upper limit of normal.
Key Trial Info
Start Date :
March 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2023
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03389750
Start Date
March 15 2018
End Date
June 28 2023
Last Update
September 7 2023
Active Locations (2)
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1
University of Kentucky
Lexington, Kentucky, United States, 40508
2
New York State Psychiatric Institute in the Division on Substance Use Disorders
New York, New York, United States, 10032