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Partial Opioid Agonist
Extended Release Naltrexone vs Buprenorphine for Opioid Use Disorder
Phase 2 & 3
Recruiting
Led By Michael S Gordon, DPA
Research Sponsored by Friends Research Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Willingness to enroll in XR-B or XR-NTX treatment in jail
Be older than 18 years old
Must not have
Current chronic pain diagnosis for which opioids are prescribed
Inability to pass a study enrollment quiz
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-7,12-months
Awards & highlights
No Placebo-Only Group
Approved for 10 Other Conditions
All Individual Drugs Already Approved
Summary
This trial will compare the effectiveness of two types of medication-assisted treatment for opioid use disorder among individuals in county jails in Maryland.
Who is the study for?
This trial is for adult male and female inmates in Maryland with moderate to severe opioid use disorder, or those treated for it within the last year. They must be due for release within 120 days, plan to live locally post-release, and pass a medical evaluation. Exclusions include severe liver issues, certain heart diseases or conditions that affect heart rhythm, untreated serious mental health disorders, pregnancy or breastfeeding women, extreme obesity (BMI > 40), and current enrollment in other medication-assisted treatments.
What is being tested?
The study compares two extended-release medications given to individuals leaving jail: XR-B (buprenorphine) versus XR-NTX (naltrexone). Participants will receive one treatment while incarcerated followed by six monthly injections after release. The assignment of either XR-B or XR-NTX is random within gender groups.
What are the potential side effects?
Potential side effects of both medications can include nausea, headache, dizziness, fatigue, injection site reactions and possible liver function changes. Side effects vary from person to person.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am willing to enroll in a treatment program while in jail.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am prescribed opioids for my chronic pain.
Select...
I was unable to pass the study's enrollment quiz.
Select...
I have not had thoughts of harming myself in the last 6 months.
Select...
I am allergic to naltrexone or buprenorphine.
Select...
I am currently receiving medication-assisted treatment for addiction in jail.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-7,12-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-7,12-months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
pharmacotherapy adherence
Secondary study objectives
Criminal activity
Patient-Reported Outcomes Measurement Information System
Re-arrest
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: XR-BExperimental Treatment1 Intervention
Extended-release buprenorphine
Group II: XR-NTXActive Control1 Intervention
Extended-release naltrexone
Find a Location
Who is running the clinical trial?
Friends Research Institute, Inc.Lead Sponsor
58 Previous Clinical Trials
21,995 Total Patients Enrolled
Michael S Gordon, DPAPrincipal InvestigatorFriends Research Institute, Inc.
1 Previous Clinical Trials
240 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe illnesses that could make participating dangerous.I have a history of moderate to severe opioid use disorder or was in a treatment program before incarceration.I am prescribed opioids for my chronic pain.I was unable to pass the study's enrollment quiz.I do not have an untreated psychiatric disorder that could make participation dangerous.I have not had thoughts of harming myself in the last 6 months.I am considered suitable for XR-B/XR-NTX treatment after a medical check.I am allergic to naltrexone or buprenorphine.I am currently receiving medication-assisted treatment for addiction in jail.I am an inmate due for release within the next 4 months.I have a history of moderate to severe opioid use disorder or was in a treatment program before incarceration.I am willing to enroll in a treatment program while in jail.I don't have a history or take medications that can cause long QT syndrome.
Research Study Groups:
This trial has the following groups:- Group 1: XR-B
- Group 2: XR-NTX
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Opioid Use Disorder Patient Testimony for trial: Trial Name: NCT04408313 — Phase 2 & 3
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