TRV734 for Opioid Use Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
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 monthsDesign:Participants will be screened under Protocol 415. They will be screened with:Medical, social, and psychiatric historyPhysical examElectrocardiogram (ECG). For this, sticky pads will be placed on the participant s chest to monitor their heartbeat.Blood and urine testsParticipants 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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop all current medications, but you must continue your regular methadone treatment. However, you should not take medications that could alter the effects of the study drugs, like strong CYP3A4 inhibitors or inducers, or medications that could affect opioid withdrawal symptoms.
Who Is on the Research Team?
David H Epstein, Ph.D.
Principal Investigator
National Institute on Drug Abuse (NIDA)
Are You a Good Fit for This Trial?
Adults aged 18-75 with opioid use disorder, on methadone treatment for at least 3 months, willing to skip doses and provide blood samples. Women must not be pregnant or breastfeeding and agree to contraception; men must practice abstinence or use barrier contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pilot Phase
Participants in an unpowered dose-finding five-session pilot phase will receive placebo, oxycodone, and a range of doses of TRV734.
Main Treatment Phase
Participants will stay at the inpatient unit for up to 21 consecutive days to test TRV734 at different doses vs. oxycodone and placebo for withdrawal suppression.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- TRV734
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute on Drug Abuse (NIDA)
Lead Sponsor