A Randomized, Double-Blind, Placebo- and Active-Controlled, Crossover Study to Evaluate the Abuse Potential of Oxymorphone Compared to Other Mu Opioid Agonists in Physically Dependent Opioid Users With Moderate-to-Severe Opioid Use Disorder
Sponsor study identifier
interventional
16
1 country
2
Study Start
March 15, 2018
Actual (reported)Primary Completion
June 15, 2022
Actual (reported)Study Completion
June 28, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 28, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 19, 2017
Actual (reported)January 4, 2018
Actual (reported)March 15, 2018
Actual (reported)June 15, 2022
Actual (reported)June 28, 2023
Actual (reported)September 7, 2023
Actual (reported)Positive Subjective Drug Effects (i.e., Drug "Liking").
The positive subjective effects of the most efficacious dose of the intravenous challenge drugs. These are measured using self-reported assessment by the participant in terms of drug "liking" rated on a visual analog scale of 0-100. Higher values indicate a greater drug effect.
Throughout study enrollment period (8-9 weeks)
Intravenous (IV) Dose Range: 1.8, 3.2, 5.6, 10 mg/70kg of the participant's body weight
IV Dose Range: 10, 18, 32, 56 mg/70kg of the participant's body weight
IV Dose Range: 3.2, 5.6, 10, 18 mg/70kg of the participant's body weight
Intravenous administration of opioid drugs (oxycodone, oxymorphone, hydromorphone), for the purpose of comparison of their abuse potential among each other, and in comparison to placebo (saline).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Kentucky
Lexington, Kentucky, 40508, United States
New York State Psychiatric Institute in the Division on Substance Use Disorders
New York, New York, 10032, United States
Sandra D Comer, PhD
New York State Psychiatric Institute / Columbia University Medical Center
16 participants (actual enrollment reported by the registry).
First Submitted
December 19, 2017
First Posted
January 4, 2018
Study Start
March 15, 2018
Actual (reported)Cannabidiol Use to Reduce Cravings in Individuals With Opioid Use Disorder on Buprenorphine
IV saline
Contact the study team to confirm eligibility.
Primary Completion
June 15, 2022
Actual (reported)Study Completion
June 28, 2023
Actual (reported)Last Updated
September 7, 2023
Results First Posted
September 7, 2023
Record last verified: 2023-08
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Source: ClinicalTrials.gov.
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