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Opioid Agonist

TRV734 for Opioid Use Disorder

Phase 2
Recruiting
Led By David H Epstein, Ph.D.
Research Sponsored by National Institute on Drug Abuse (NIDA)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 18 and 75.
Be older than 18 years old
Must not have
Current uncontrolled DSM-5 Major Depressive Disorder diagnosis.
Inability to pass the NIDA Evaluation of Potential Research Participants Ability to Consent questionnaire ( consent quiz ) for 20-DA-N014.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within-session

Summary

This trial is testing if a new drug, TRV734, relieves withdrawal symptoms and has fewer side effects than oxycodone in people with OUD.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects of TRV734 are not listed here, they may include typical opioid-related issues such as nausea, drowsiness, constipation or headaches. The study aims to determine if TRV734 has fewer side effects than existing treatments like oxycodone.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with severe depression that is not currently under control.
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I was unable to pass the consent understanding test for the study.
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I have no conditions that affect blood or urine tests.
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I do not have any serious health issues that would make research participation unsafe.
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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within-session
This trial's timeline: 3 weeks for screening, Varies for treatment, and within-session for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
sows
Secondary study objectives
COWS
NIH Toolbox test battery

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TRV734Experimental Treatment1 Intervention
TRV734 at different doses vs. oxycodone for withdrawal suppression
Group II: PlaceboPlacebo Group1 Intervention
Placebo capsule
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TRV734
2015
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)Lead Sponsor
2,587 Previous Clinical Trials
3,328,484 Total Patients Enrolled
David H Epstein, Ph.D.Principal InvestigatorNational Institute on Drug Abuse (NIDA)
5 Previous Clinical Trials
784 Total Patients Enrolled

Media Library

TRV734 (Opioid Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04316559 — Phase 2
~25 spots leftby Sep 2026
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