Long-acting Naltrexone for Opioid Addiction

Recruiting in Palo Alto (17 mi)

Overseen by Michael S Gordon, DPA

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Friends Research Institute, Inc.

Must be taking: XR-NTX

Must not be taking: Methadone, Buprenorphine

Disqualifiers: Liver issues, Heart disease, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it does allow for adequately treated medical and psychiatric conditions with appropriate medications. It seems you may continue certain medications if they are well-managed.

What data supports the effectiveness of the drug for opioid addiction?

Research shows that extended-release naltrexone (XR-NTX) is effective in maintaining abstinence, reducing cravings, and preventing relapse in people with opioid addiction. It is also used successfully in alcohol dependence, suggesting its broader potential in treating addictive disorders. ^{1 2 3 4 5}

Is long-acting naltrexone safe for humans?

Long-acting naltrexone (XR-NTX, Vivitrol) is generally considered safe for humans, with studies showing good safety and tolerability. It has been used for both alcohol and opioid dependence without significant liver issues or problems managing acute pain. ^{2 3 4 5 6}

How is the drug XR-NTX different from other opioid addiction treatments?

XR-NTX is unique because it is a once-a-month injectable drug that blocks the effects of opioids, helping to prevent relapse after detoxification. Unlike daily oral treatments, its extended-release formulation improves adherence by requiring less frequent dosing. ^{1 2 3 6 7}

Research Team

Michael S Gordon, DPA

Principal Investigator

Friends Research Institute, Inc.

Eligibility Criteria

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.

Inclusion Criteria

Inmates not meeting the opioid-dependence criterion will be eligible if they were treated in an opioid agonist treatment program during the year before incarceration

I am considered suitable for XR-NTX treatment after a medical check.

Planning to live in Baltimore City or County

Exclusion Criteria

Suicidal ideation within the past 6-months

Liver function test levels greater than three times normal

I do not have any untreated serious illnesses like heart disease or unstable diabetes.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

One injection of XR-NTX in prison, followed by six monthly injections post-release in the community

7 months

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 months

5 visits (in-person)

Long-term follow-up

Participants are evaluated for re-incarceration, criminal activity, and HIV risk behaviors

12 months

Treatment Details

Interventions

• XR-NTX (Opioid Antagonist)

Trial Overview 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.

Participant Groups

Group I: Vivitrol at place of residence Experimental Treatment 2 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 program Active Control 2 Interventions

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

Who Is Running the Clinical Trial?

Friends Research Institute, Inc.

Lead Sponsor

Trials

60

Recruited

22,500+

Dr. Steven Carswell

Friends Research Institute, Inc.

Chief Executive Officer

PhD

Dr. Robert Schwartz

Friends Research Institute, Inc.

Chief Medical Officer since 2023

MD

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Executive Officer since 2003

MD from National Autonomous University of Mexico

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Medical Officer since 2003

MD from National Autonomous University of Mexico

Findings from Research

In an open-label study of 20 individuals with opioid addiction, a safe and effective outpatient transition to extended release injectable naltrexone (XR-NTX) was achieved using a combination of very low dose naltrexone and decreasing doses of buprenorphine over a 7-day period.

The results showed significant reductions in withdrawal symptoms, cravings, and drug use during the induction phase and after XR-NTX administration, with no serious adverse events reported, indicating a promising approach for outpatient treatment of opioid addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended release naltrexone injection is performed in the majority of opioid dependent patients receiving outpatient induction: a very low dose naltrexone and buprenorphine open label trial. Mannelli, P., Wu, LT., Peindl, KS., et al.[2021]

Extended-release naltrexone (XR-NTX) is being tested as a monthly injectable treatment for opioid use disorders, specifically targeting individuals involved with the criminal justice system, in a 24-week open-label randomized controlled trial.

The study aims to determine if XR-NTX can effectively reduce opioid relapse rates compared to standard treatment options, with assessments occurring every two weeks and follow-ups at 12 and 18 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended-release naltrexone to prevent relapse among opioid dependent, criminal justice system involved adults: rationale and design of a randomized controlled effectiveness trial. Lee, JD., Friedmann, PD., Boney, TY., et al.[2018]

In a 1-year open-label extension study involving 114 patients, injectable extended-release naltrexone (XR-NTX) demonstrated long-term efficacy, with 50.9% of participants remaining abstinent from opioids throughout the study.

The treatment was generally safe, with only 21.1% of patients reporting adverse events and no severe adverse events noted, although 16.7% experienced elevated liver function tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Injectable extended-release naltrexone for opioid dependence: an open label study of long-term safety and efficacy]. Krupitsky, EM., Nunes, EV., Ling, W., et al.[2016]

Extended-release naltrexone (XR-NTX) has been shown to significantly increase both initial and 6-month abstinence in alcohol-dependent adults, particularly those who have achieved at least 4 days of initial abstinence.

In opioid dependence, XR-NTX effectively maintains abstinence, reduces cravings, and prevents relapse after detoxification, demonstrating its potential as a valuable treatment option in both primary care and public health systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intramuscular extended-release naltrexone: current evidence. Gastfriend, DR.[2022]

Induction success for extended-release naltrexone (XR-NTX) is significantly lower in individuals requiring opioid detoxification (62.6%) compared to those already detoxified (85.0%), indicating that detoxification status is crucial for treatment initiation.

Adherence to XR-NTX is relatively low, with only 44.2% of individuals completing all scheduled injections, and adherence rates are notably higher in controlled research settings compared to routine care, which limits the overall effectiveness of XR-NTX in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended-release injectable naltrexone for opioid use disorder: a systematic review. Jarvis, BP., Holtyn, AF., Subramaniam, S., et al.[2019]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Extended release naltrexone injection is performed in the majority of opioid dependent patients receiving outpatient induction: a very low dose naltrexone and buprenorphine open label trial. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Extended-release naltrexone to prevent relapse among opioid dependent, criminal justice system involved adults: rationale and design of a randomized controlled effectiveness trial. [2018]

3. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Injectable extended-release naltrexone for opioid dependence: an open label study of long-term safety and efficacy]. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Intramuscular extended-release naltrexone: current evidence. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Extended-release injectable naltrexone for opioid use disorder: a systematic review. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Extended-release vs. oral naltrexone for alcohol dependence treatment in primary care (XON). [2020]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Extended-release intramuscular naltrexone (VIVITROL®): a review of its use in the prevention of relapse to opioid dependence in detoxified patients. [2021]