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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04316559
The ClinicalTrials.gov registry entry for NCT04316559 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Drug Abuse (NIDA), which has 335 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04316559 reports 0 study locations.
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.
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