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NCT04316559 · ClinicalTrials.gov registry record · Phase 2
Biased Opioid Agonists for Treatment of Opioid Withdrawal in OUD
A Phase 2 study, sponsored by National Institute on Drug Abuse (NIDA).
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT04316559: Clinical Trial Phase 2 study, sponsored by National Institute on Drug Abuse (NIDA).
NCT04316559 is a Phase 2 study that was terminated before completion, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04316559, a Phase 2 study, was terminated before completion, sponsored by National Institute on Drug Abuse (NIDA).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
Background: People with opioid-use disorder (OUD) might benefit from having more treatment drugs to choose from. A new drug, TRV734, could be used like methadone to treat OUD. It might not have as many side effects. Objective: To test if TRV734 relieves withdrawal symptoms and has fewer side effects than oxycodone in people with OUD. Eligibility: People ages 18-75 who have been receiving daily treatment with methadone for opioid use disorder for at least three (3) months Design: Participants will be screened under Protocol 415. They will be screened with: * Medical, social, and psychiatric history * Physical exam * Electrocardiogram (ECG): For this, sticky pads will be placed on the participant's chest to monitor their heartbeat. * Blood and urine tests Participants will stay in a residential unit for 13-21 days. Most days, participants will receive their regular daily dose of methadone. On 4 or 5 occasions, 3-4 days apart, participants will skip two doses of methadone in a row. About 4 hours after they skip the second dose, they will have an IV catheter inserted with a needle so that blood samples can be taken. They will take capsules of either oxycodone, a placebo, or the study drug. They will have an ECG. They will complete questionnaires. Their blood pressure, pupil size, and alertness will be tested. They will then take their usual dose of methadone. Participants will give daily urine and breath samples.
Primary Outcome
The subjective opioid withdrawal scale (SOWS) is a widely used measure for evaluating the intensity of opioid withdrawal symptoms. It consists of 16 items (such as "I feel nauseated" and "I am shaking"), each rated by participants on a 5-point scale of intensity from 0 (not at all) to 4 (extremely). The score is a sum of all item ratings; scores can range from 0 to 64, with standard cutoffs for mild withdrawal (1-10), moderate withdrawal (11-20), and severe withdrawal (21 or higher). Higher scor
Interventions
- OTHER Placebo
- DRUG Oxycodone
- DRUG TRV734
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2021-12-27 |
| Est. Completion | 2025-02-14 |
| Phase | Phase 2 |
Why NCT04316559 stopped before completion
NCT04316559 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04316559 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04316559 about?
NCT04316559 is a clinical study titled "Biased Opioid Agonists for Treatment of Opioid Withdrawal in OUD". Background: People with opioid-use disorder (OUD) might benefit from having more treatment drugs to choose from. A new drug, TRV734, could be used like methadone to treat OUD. It might not have as many side effects. Objective: To test if TRV734 relieves withdrawal symptoms and has fewer side effe...
What is the current status of trial NCT04316559?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2021-12-27. Estimated completion is 2025-02-14.
What interventions are being tested in trial NCT04316559?
The interventions under investigation include: Placebo (OTHER), Oxycodone (DRUG), TRV734 (DRUG).
Who is sponsoring clinical trial NCT04316559?
This trial is sponsored by National Institute on Drug Abuse (NIDA), which has 335 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04316559's enrollment target sits among peer trials
5 2000th of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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