Extended Release Naltrexone vs Buprenorphine for Opioid Use Disorder

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 2 & 3

Waitlist Available

Sponsor: Friends Research Institute, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The proposed study is a Type 1 hybrid effectiveness-implementation trial. Individuals with opioid use disorder in county jails throughout the state of Maryland will be randomly assigned within gender within jail to one of two groups: Arm 1. XR-B (n=120). XR-B in jail followed by 6 monthly injections post-release at a community treatment program. Arm 2. XR-NTX (n=120). One injection of XR-NTX in jail, followed by 6 monthly injections post-release at a community treatment program.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot participate if you are currently on medications that prolong the QTc interval or if you are enrolled in jail-based MOUD pharmacotherapy like methadone, buprenorphine, or naltrexone.

Is extended-release naltrexone or buprenorphine safe for treating opioid use disorder?

Research shows that both extended-release naltrexone (XR-NTX) and buprenorphine-naloxone (BUP-NX) are generally safe for treating opioid use disorder, with no significant differences in safety outcomes between the two treatments.

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How does the drug XR-NTX differ from BUP-NX for opioid use disorder?

XR-NTX is a monthly injectable drug that blocks opioid effects, while BUP-NX is a daily sublingual drug that partially activates opioid receptors. XR-NTX requires detoxification before starting, making it harder to initiate compared to BUP-NX.

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Eligibility Criteria

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.

Inclusion Criteria

Planning to live in one of the 7 participating counties and/or surrounding counties

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

I am an inmate due for release within the next 4 months.

Exclusion Criteria

I do not have any severe illnesses that could make participating dangerous.

Breastfeeding (for women)

I am prescribed opioids for my chronic pain.

Participant Groups

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.

Group I: XR-B Experimental Treatment 1 Intervention

Extended-release buprenorphine

Group II: XR-NTX Active Control 1 Intervention

Extended-release naltrexone

XR-B is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Buprenorphine for:

• Opioid use disorder
• Pain management

🇪🇺 Approved in European Union as Buprenorphine for:

• Opioid dependence
• Chronic pain

🇨🇦 Approved in Canada as Buprenorphine for:

• Opioid use disorder
• Severe chronic pain

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Friends Research Institute Baltimore, MD

Who Is Running the Clinical Trial?

Friends Research Institute, Inc. Lead Sponsor

References

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

Patients' perspectives on initiating treatment with extended-release naltrexone (XR-NTX). [2022] The National Drug Abuse Treatment Clinical Trials Network (CTN) multisite comparative-effectiveness study ("X:BOT") by Lee et al. (2018) found that, once initiated, extended-release naltrexone (XR-NTX) is as similarly safe and effective as sublingual buprenorphine-naloxone (BUP-NX) for the treatment of opioid use disorder (OUD). However, the detoxification hurdle makes XR-NTX much more difficult to initiate than BUP-NX. This hurdle highlights the need to better understand how patients transition from active opioid use to XR-NTX treatment.

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

Cost-Effectiveness of Buprenorphine-Naloxone Versus Extended-Release Naltrexone to Prevent Opioid Relapse. [2020] Not enough evidence exists to compare buprenorphine-naloxone with extended-release naltrexone for treating opioid use disorder.

3. England pubmed.ncbi.nlm.nih.gov

Risk of Relapse Among Opioid-Dependent Patients Treated With Extended-Release Naltrexone or Buprenorphine-Naloxone: A Randomized Clinical Trial. [2021] Compare the risk of relapse to heroin and other illicit opioids among opioid-dependent patients receiving treatment with extended-release naltrexone (XR-NTX) or buprenorphine-naloxone (BP-NLX).

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

Buprenorphine Naloxone and Extended Release Injectable Naltrexone for the Treatment of Opioid Use Disorder Among a Veteran Patient Sample: A Retrospective Chart Review. [2021] Label="OBJECTIVE">Previous research has demonstrated the effectiveness of both extended-release injectable naltrexone (XR-NTX) and buprenorphine/naloxone (BUP-NX) in the treatment of opioid use disorder (OUD). However, studies using real-world samples with multiple medical and psychiatric comorbidities are lacking. The study's primary aims were to: (1) compare clinical presentations in an inclusive sample of OUD-diagnosed US military veterans receiving XR-NTX and BUP-NX, and (2) investigate differences in 90-day treatment outcomes between these two groups. Methods: The medical records of 79 patients receiving medications to treat OUD in a VA hospital's addiction outpatient treatment program were reviewed retrospectively. The analysis included all veterans who initiated medication treatment during the study period. Differences between medication groups on co-occurring diagnoses, treatment retention, and related outcomes were examined. Results: The two groups were similar in medical and psychiatric comorbidity, although the BUP-NX group were more likely to have a pain diagnosis. No statistically significant differences in retention or toxicology results were found between the two groups over the 90-day study period. The rate of positive urine screens for the BUP-NX group was 19.2% for opiates and 13.5% for other illicit substances, and 3.7% and 11.1% respectively for the XR- NTX group. Conclusion: There was no evidence that 90-days outcomes differed for veterans based on medication received, and there were more similarities than differences in clinical characteristics. Additional research is needed, including larger sample size and prospective randomized control trial to evaluate VA patients' treatment outcomes receiving BUP-NX or XR-NTX for OUD.

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

Extended-release injectable naltrexone for opioid use disorder: a systematic review. [2019] Label="AIMS">To review systematically the published literature on extended-release naltrexone (XR-NTX, Vivitrol® ), marketed as a once-per-month injection product to treat opioid use disorder. We addressed the following questions: (1) how successful is induction on XR-NTX; (2) what are adherence rates to XR-NTX; and (3) does XR-NTX decrease opioid use? Factors associated with these outcomes as well as overdose rates were examined.

6. England pubmed.ncbi.nlm.nih.gov

Is extended release naltrexone superior to buprenorphine-naloxone to reduce drinking among outpatients receiving treatment for opioid use disorder? A secondary analysis of the CTN X:BOT trial. [2023] The comparative effectiveness of extended-release naltrexone versus buprenorphine-naloxone for opioid relapse prevention (X:BOT) trial showed that following induction, treatment with the sublingual agonist (buprenorphine-naloxone, BUP-NX) or injected antagonist (extended release naltrexone, XR-NTX) produced similar reductions in opioid relapse in injection users with opioid use disorder (OUD). Because XR-NTX reduces drinking in alcohol use disorder (AUD), we conducted a secondary analysis of the X:BOT sample of patients successfully inducted onto treatment to determine whether XR-NTX (n = 204) was superior to BUP-NX (n = 270) in reducing drinking or heavy drinking in patients with OUD.

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

Does XR injectable naltrexone prevent relapse as effectively as daily sublingual buprenorphine-naloxone? [2021] YES. MONTHLY EXTENDED-RELEASE INJECTABLE NALTREXONE (XR-NTX) TREATS OPIOID USE DISORDER AS EFFECTIVELY AS DAILY SUBLINGUAL BUPRENORPHINE-NALOXONE (BUP-NX) WITHOUT CAUSING ANY INCREASE IN SERIOUS ADVERSE EVENTS OR FATAL OVERDOSES. (STRENGTH OF RECOMMENDATION: A, 2 GOOD-QUALITY RCTS).