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NCT03837860 · ClinicalTrials.gov registry record · Early Phase 1
Reducing the Abuse of Opioids in Drug Users
A Early Phase 1 study, sponsored by The University of Texas Health Science Center at San Antonio.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 3
- Enrollment target
NCT03837860 is a Early Phase 1 study that was terminated before completion, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 3 participants.
The verdict
NCT03837860, a Early Phase 1 study, was terminated before completion, sponsored by The University of Texas Health Science Center at San Antonio.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
The consequences of prescription opioid abuse are serious and the number of deaths from unintended overdose have quadrupled over the last 15+ years. Opioid analgesics remain among the most commonly abused class of substances in the United States. Moreover, patients who take pain medications for legitimate reasons may develop an opioid use disorder (OUD), with as many as 1 in 4 patients becoming dependent on their pain medications. Because of changing access to prescription opioid analgesics due to an increasingly negative prescribing climate and changes in guidelines, patients often turn to heroin, with an estimated 1 in 15 pain patients trying heroin within 10 years. Pain is a symptom that can be severely debilitating and needs to be treated adequately to improve the quality of life. Clinicians, then, are in a proverbial "catch-22" situation whereby treating a patient's chronic pain also exposes them to medications with substantial abuse liability and overdose risk. In this proposal, a method aimed at reducing the abuse potential of prescription opioid medications, without altering their analgesic efficacy, is described. The study team hypothesize that this can be accomplished by administering a fixed-dose-combination of an opioid with an atypical antipsychotic drug, in the same pill or capsule.
Interventions
- DRUG Oxycodone/Placebo
- DRUG Oxycodone/Risperidone
- DRUG Oxycodone/Ziprasidone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2019-04-01 |
| Est. Completion | 2022-01-21 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03837860
The ClinicalTrials.gov registry entry for NCT03837860 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center at San Antonio, which has 378 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Oxycodone/Placebo is the first listed.
NCT03837860 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03837860 about?
NCT03837860 is a clinical study titled "Reducing the Abuse of Opioids in Drug Users". The consequences of prescription opioid abuse are serious and the number of deaths from unintended overdose have quadrupled over the last 15+ years. Opioid analgesics remain among the most commonly abused class of substances in the United States. Moreover, patients who take pain medications for legi...
What is the current status of trial NCT03837860?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 3 participants. The study started on 2019-04-01. Estimated completion is 2022-01-21.
What interventions are being tested in trial NCT03837860?
The interventions under investigation include: Oxycodone/Placebo (DRUG), Oxycodone/Risperidone (DRUG), Oxycodone/Ziprasidone (DRUG).
Who is sponsoring clinical trial NCT03837860?
This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.
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