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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
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 belowSelect...
I am between 18 and 75 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within-session
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within-session
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
2,482 Previous Clinical Trials
2,621,022 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
Eligibility Criteria:
This trial includes the following eligibility 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.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 have no conditions that affect blood or urine tests.I am between 18 and 75 years old.I am not on medications that affect opioid effects, like certain enzyme inhibitors or drugs for withdrawal symptoms.You have experienced withdrawal symptoms when stopping opioid use or have had difficulty tolerating moderate withdrawal symptoms in the past.I am willing to give blood samples through an IV in my arm.You have been diagnosed with a particular type of mental health condition called psychotic or bipolar disorder according to the DSM-5.I am not pregnant and agree to use birth control during the study.You are okay with not taking your methadone for two to three mornings during the study, and you have done this before without experiencing severe withdrawal symptoms like vomiting, diarrhea, or other very uncomfortable symptoms.I have been on methadone for opioid addiction for over 3 months.I am considered menopausal according to my age and menstrual history.I am not pregnant or breastfeeding.I am a man who will not father a child or donate sperm for 3 months after starting the study drug.
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
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