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Opioid Antagonist

Long-acting Naltrexone for Opioid Addiction

Phase 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1,2,3,4,5,6,7 and 12-months following release from prison

Awards & highlights

Study Summary

This trial will focus on whether giving XR-NTX at a patients' home will increase how well the medication works.

Who is the study for?

This trial is for adults in prison due to be released within 30 days, living opioid-free with a history of opioid disorder. They must plan to live in Baltimore City or County and agree to XR-NTX treatment without seeking methadone or buprenorphine post-release. Excluded are those with severe liver issues, untreated serious mental health conditions, chronic pain on opioids, pregnant or breastfeeding women, high suicide risk individuals, and those with certain medical conditions.Check my eligibility

What is being tested?

The study tests if giving the drug XR-NTX at the patient's home improves adherence compared to receiving it at an opioid treatment program after release from prison. Participants will receive one injection before release and six monthly injections afterwards; they're randomly assigned to get these either at their residence or a treatment facility.See study design

What are the potential side effects?

While not explicitly listed here, common side effects of long-acting Naltrexone (XR-NTX) can include nausea, headache, dizziness, fatigue, injection site reactions and potentially more serious effects like liver damage in susceptible individuals.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1,2,3,4,5,6,7 and 12-months following release from prison

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1,2,3,4,5,6,7 and 12-months following release from prison

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1,2,3,4,5,6,7 and 12-months following release from prison for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Any illicit opioid used

Injection drug use and HIV sexual risk factors

criminal activity

+3 more

Secondary outcome measures

Treatment Group Equilibration

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Vivitrol at place of residenceExperimental Treatment2 Interventions

One injection of long-acting naltrexone (XR-NTX) in prison, followed by 6 monthly injections post-release at the participants's place of residence utilizing mobile medical treatment

Group II: Vivitrol at opioid treatment programActive Control2 Interventions

One injection of long-acting naltrexone (XR-NTX) in prison, followed by 6 monthly injections post-release at a community opioid treatment program.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Naltrexone

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Friends Research Institute, Inc.Lead Sponsor

52 Previous Clinical Trials

20,368 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,470 Previous Clinical Trials

2,619,491 Total Patients Enrolled

5 Trials studying Opioid Addiction

648 Patients Enrolled for Opioid Addiction

Michael S Gordon, DPAPrincipal InvestigatorFriends Research Institute, Inc.

1 Previous Clinical Trials

240 Total Patients Enrolled

Media Library

XR-NTX (Opioid Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT02867124 — Phase 3

Opioid Addiction Research Study Groups: Vivitrol at place of residence, Vivitrol at opioid treatment program

Opioid Addiction Clinical Trial 2023: XR-NTX Highlights & Side Effects. Trial Name: NCT02867124 — Phase 3

XR-NTX (Opioid Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02867124 — Phase 3

Frequently Asked Questions

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

Are there other research studies that focus on where people live?

"Out of the 52 ongoing clinical trials studying place of residence, 16 are in Phase 3. Many of these studies originated in New york City; however, there are a total of 175 research facilities running these sorts of tests."

Answered by AI

Are new participants still being sought for this experiment?

"That is correct. The information available on clinicaltrials.gov indicates that the trial is currently recruiting patients. This particular study was posted on 1/1/2017 with the most recent update taking place on 8/18/2021. They are looking to enroll 240 individuals at a single location."

Answered by AI

Does where a patient lives have any impact on their safety?

"There is some data to suggest that place of residence may have an impact on safety, so it received a score of 3."

Answered by AI

What is place of residence usually given for?

"place of residence is a medication that's often used to help patients manage their weight long-term. Additionally, it can be helpful for those struggling with pain or lack of energy resulting from reduced calorie diets."

Answered by AI

How many people are participating in this research project at most?

"That is correct, the online clinical trials database has this listing for an active trial that began recruitment on 1/1/2017. The most recent update was 8/18/2021 and the study plans to enroll 240 participants at a single site."

Answered by AI