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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.
Willing to provide blood samples through an intravenous catheter to either upper extremity.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within-session
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
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I am willing to give blood samples through an IV in my arm.
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I am not pregnant and agree to use birth control during the study.
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I have been on methadone for opioid addiction for over 3 months.
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I am considered menopausal according to my age and menstrual history.
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I am a man who will not father a child or donate sperm for 3 months after starting the study drug.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
sows
Secondary outcome measures
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
2,464 Previous Clinical Trials
2,618,529 Total Patients Enrolled
David H Epstein, Ph.D.Principal InvestigatorNational Institute on Drug Abuse (NIDA)
5 Previous Clinical Trials
861 Total Patients Enrolled

Media Library

TRV734 (Opioid Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04316559 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the approximate magnitude of participants in this research endeavor?

"Affirmative. Per the clinicaltrials.gov archives, this medical investigation is currently recruiting with a launch date of December 27th 2021 and an update made on November 23rd 2022. The trial requires 64 volunteers to be recruited from one site."

Answered by AI

Is there an opportunity for me to join this medical experiment?

"This research requires opioid abuse sufferers aged between 18 and 75, with a total of 64 participants allowed to take part."

Answered by AI

Has the Drug and Food Administration endorsed TRV734?

"TRV734's safety has been studied enough to receive a score of 2, as there is evidence proving its security but none which affirms its efficacy in treatment."

Answered by AI

Is this medical trial still accepting new participants?

"Affirmative. The details hosted on clinicaltrials.gov demonstrate that this medical study, which was first published in late December of 2021, is still enrolling participants. 64 individuals are needed to be sourced from a single research site."

Answered by AI

Are geriatric individuals excluded from this research program?

"As specified in the enrollment guidelines, individuals between 18 and 75 are eligible to participate. Moreover, there are 22 studies for minors under the age of 18 as well as 240 trials for seniors above 65."

Answered by AI

Who else is applying?

What site did they apply to?
National Institute on Drug Abuse
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I was sent this through my email so I decided to give it a try. Also eventually I would like to taper off Methadone. I will need something in its place.
PatientReceived no prior treatments
~33 spots leftby Sep 2026