Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Clinical Trial Early Phase 1 study, sponsored by The University of Texas Health Science Center at San Antonio.
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, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The bipolar VAS is used to measure the Change in magnitude of "drug liking". The Drug Effects Questionnaire AKA the bipolar VAS of Drug Likability is a 5 item self-administered assessment where participants place a mark on a line from 0 to 100, "strongly dislike" at 0 (on the left hand side), "no effect" at 50 (in the center) and "strongly like" at 100 (on the far right). Change from visit 2 to visit 6 will be measured.
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 |
Why NCT03837860 stopped before completion
NCT03837860 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 3 interventions - of which Oxycodone/Placebo is the first listed.
NCT03837860 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03837860's enrollment target sits among peer trials
3 1948th of 2000 higher than 28 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI