Biased Opioid Agonists for Treatment of Opioid Withdrawal in OUD (NCT04316559) | Clinical Trial Compass
TerminatedPhase 2
Biased Opioid Agonists for Treatment of Opioid Withdrawal in OUD
Stopped: Drug availability
United States5 participantsStarted 2021-12-27
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
Participants will be eligible for inclusion in the study if they meet the following criteria:
* Age between 18 and 75.
* Currently receiving daily treatment with methadone (dose range 60-150 mg/day) for opioid use disorder (OUD) for at least 3 months prior to first study drug dose per participant's Opioid Treatment Program (OTP) and self-report. However, we will allow flexibility in the dose range during that 3-month period (such as an occasional missed methadone dose or a temporarily decreased methadone dose) if, in the judgement of the MAI, the candidate is stable on methadone overall and has not lost tolerance to methadone.
* Willing to miss two to three mornings' doses of methadone (without supplementing with other opioids), and reporting having done so in the past without severe withdrawal symptoms on the first day-with severe defined here as any of the following: repeated vomiting, repeated bouts of diarrhea, or any other symptoms so painful or uncomfortable that the participant would not want to experience them several times in this study.
* Willing to provide blood samples through an intravenous catheter to either upper extremity.
* For women of childbearing potential: must have a negative serum or urine pregnancy test within 72 hours prior to the first study drug dose (active or placebo) AND agree to use an adequate method of contraception to avoid pregnancy for a period of 3 months beginning from 30 days prior to first dose of study drug. Wom…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Withdrawal Symptoms Assessed by the Subjective Opioid Withdrawal Scale (SOWS)
Timeframe: Up to four hours during each session, for a total of five noncontiguous session days