What side effects are associated with this type of intervention?

The most common treatments for opioid addiction include naltrexone, methadone, and buprenorphine. Naltrexone, particularly in its extended-release form (XR-NTX), can cause side effects such as nausea, headache, dizziness, fatigue, and injection site reactions. Methadone may lead to constipation, sweating, sexual dysfunction, and respiratory depression. Buprenorphine can cause side effects like constipation, headache, nausea, and potential dental issues when taken sublingually. All these medications require careful monitoring to manage these side effects effectively.

What other types of research exist?

Promising novel alternatives to XR-NTX for opioid addiction treatment include: 1) Sublingual and buccal buprenorphine formulations, which offer effective opioid receptor modulation with a favorable safety profile. 2) Buprenorphine/naloxone combination therapy, which reduces misuse potential while maintaining efficacy. 3) Long-acting injectable buprenorphine, providing sustained release and improved adherence. These alternatives have shown efficacy in reducing opioid cravings and preventing relapse, with some offering the convenience of less frequent dosing.

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Opioid Antagonist

Long-acting Naltrexone for Opioid Addiction

Q: What prior FDA approvals exist?

The FDA has approved several medications for the treatment of opioid addiction, including extended-release naltrexone (XR-NTX), which blocks opioid receptors to reduce cravings and prevent relapse. Other FDA-approved treatments include buprenorphine, a partial opioid agonist that reduces withdrawal symptoms and cravings, and methadone, a full opioid agonist used in maintenance therapy to prevent withdrawal and reduce cravings. These medications are often used in combination with counseling and behavioral therapies to provide a comprehensive approach to opioid addiction treatment.

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

Must not have

Current chronic pain diagnosis for which opioids are prescribed

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Pivotal Trial

Approved for 10 Other Conditions

Summary

This trial tests if giving long-lasting naltrexone injections at home can help pre-release prisoners with opioid use disorders stick to their treatment. Naltrexone works by blocking the effects of opioids, making them less appealing. A long-lasting version of naltrexone has been developed and approved in the USA and Russia.

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.

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.

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.

Eligibility Criteria

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Any illicit opioid used

Injection drug use and HIV sexual risk factors

criminal activity

+3 more

Secondary study objectives

Treatment Group Equilibration

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

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

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for opioid addiction include medications like extended-release naltrexone (XR-NTX), methadone, and buprenorphine. XR-NTX works by blocking opioid receptors in the brain, which reduces cravings and prevents relapse by making it impossible for opioids to produce their euphoric effects. Methadone is a long-acting opioid agonist that reduces withdrawal symptoms and cravings by activating opioid receptors at a controlled level, without producing a high. Buprenorphine is a partial opioid agonist that also reduces cravings and withdrawal symptoms but has a ceiling effect that lowers the risk of misuse. These treatments are crucial for opioid addiction patients as they help manage withdrawal symptoms, reduce cravings, and lower the risk of relapse, thereby supporting long-term recovery.