Biased Opioid Agonists for Treatment of Opioid Withdrawal in OUD
Status:
Recruiting
Trial end date:
2022-09-30
Target enrollment:
Participant gender:
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 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 13-26 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.