Phase 2
N=16
A Study to Evaluate the Abuse Potential of Oxymorphone Compared to Other Mu Opioid Agonists.
Opioid Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03389750 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Positive Subjective Drug Effects (i.e., Drug "Liking"). — 52.1; 57.5; 71.8; 71.5 units on a scale — p=.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Intravenous Challenge Drug (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Positive Subjective Drug Effects (i.e., Drug "Liking"). |
52.1; 57.5; 71.8; 71.5; 84; 66.3 | .0001 sig |
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-opioid analgesics. The present study is designed to examine the abuse liability of intravenous oxymorphone compared to other mu opioid agonists (oxycodone, and hydromorphone) among physically dependent opioid abusers.
Eligibility Criteria
Inclusion Criteria
- 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 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 3.0x upper limit of normal.
Data sourced from ClinicalTrials.gov (NCT03389750). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.