CompletedPhase 2

A Study to Evaluate the Abuse Potential of Oxymorphone Compared to Other Mu Opioid Agonists.

United States16 participantsStarted 2018-03-15

Plain-language 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.

Who can participate

Age range21 Years – 55 Years

SexALL

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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.

Exclusion criteria

✕. ≥ 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.
✕. 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.

What they're measuring

Positive Subjective Drug Effects (i.e., Drug "Liking").

Timeframe: Throughout study enrollment period (8-9 weeks)

Trial details

NCT IDNCT03389750

SponsorNew York State Psychiatric Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-15

Results submitted2023-05-25

View on ClinicalTrials.gov More Opioid Use Disorder trials