TRV734 for Opioid Use Disorder

Overseen By NIDA IRP Screening Team

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Institute on Drug Abuse (NIDA)

Must be taking: Methadone

Must not be taking: Antidepressants, Antipsychotics, Benzodiazepines, others

Disqualifiers: Psychotic disorder, Bipolar, Major depression, Alcohol dependence, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

5 Participants Needed

Trial Summary

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 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.

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.

Research Team

David H Epstein, Ph.D.

Principal Investigator

National Institute on Drug Abuse (NIDA)

Eligibility Criteria

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

Participants must be able to speak, read, and understand English. Justification: This study uses scales and experimental procedures that are validated only in English. This includes the assessments conducted to test the primary and secondary outcomes and is therefore required to maintain the research integrity of the study.

You have experienced strong withdrawal symptoms after missing a day or two of taking methadone. We will use a special questionnaire to ask you about your withdrawal history for this study.

I am between 18 and 75 years old.

Exclusion Criteria

I do not have any serious health issues that would make research participation unsafe.

I have been diagnosed with severe depression that is not currently under control.

I was unable to pass the consent understanding test for the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pilot Phase

Participants in an unpowered dose-finding five-session pilot phase will receive placebo, oxycodone, and a range of doses of TRV734.

30 days

Inpatient stay

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.

21 days

Inpatient stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• TRV734

Trial Overview The trial is testing TRV734's effectiveness in relieving withdrawal symptoms compared to oxycodone, without as many side effects. Participants will stay in a unit for up to three weeks, receive their regular methadone dose, occasionally skip it for testing purposes, and take either the study drug, placebo or oxycodone.

Participant Groups

Group I: TRV734 Experimental Treatment 1 Intervention

TRV734 at different doses vs. oxycodone for withdrawal suppression

Group II: Placebo Placebo Group 1 Intervention

Placebo capsule

Who Is Running the Clinical Trial?

National Institute on Drug Abuse (NIDA)

Lead Sponsor

Trials

2,658

Recruited

3,409,000+