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Opioid Partial Agonist

Buprenorphine + XR-Naltrexone for Opioid Use Disorder (COMBO Trial)

Phase 2 & 3

Recruiting

Led By Adam Bisaga, MD

Research Sponsored by New York State Psychiatric Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

In otherwise good health based on complete medical history, physical examination, vital signs measurement, ECG, and laboratory tests (hematology, blood chemistry, urinalysis) within normal ranges.

Meets current DSM-5 criteria for current opioid use disorder of at least six months duration supported by urine toxicology positive for opioids OR naloxone challenge if seeking detoxification and XR-NTX induction OR confirmed recent detoxification treatment for opioids.

Must not have

- Current severe alcohol, benzodiazepine, or other depressant or sedative hypnotic use likely to require a complicated medical detoxification (routine alcohol and sedative detoxifications may be included)

Maintenance on buprenorphine or frequent buprenorphine use in the week prior to XR-NTX induction (must be using no more than 8 mg of buprenorphine per day and no more than 3 days per week). If consenting after initial XR-NTX injection, any use of buprenorphine since XR-NTX induction is exclusionary

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 20 weeks

Awards & highlights

Summary

This trial will compare the effectiveness of a new drug combination to treating opioid addiction with extended release naltrexone alone. It is a double-blind, placebo-controlled study, meaning neither the participants nor the researchers will know who is receiving the new treatment or the placebo. The study will last 24 weeks, during which participants will receive six injections of either the new treatment or a placebo. The study's goal is to see if the new treatment can improve treatment retention, reduce opioid craving, and improve mood.

Who is the study for?

Adults aged 18-65 with opioid use disorder for at least six months, confirmed by tests or recent detox treatment, and in good health based on medical exams. They must understand the difference between agonist and antagonist treatments and be interested in antagonist-based relapse prevention without severe alcohol or sedative use, significant liver issues, suicidal tendencies, pregnancy, or certain medication allergies.

What is being tested?

The trial is testing if combining buprenorphine-naloxone with extended-release naltrexone (XR-naltrexone) improves treatment retention and mood over 24 weeks compared to a placebo. Participants will receive XR-naltrexone injections every four weeks for a total of six doses in this double-blind study.

What are the potential side effects?

Possible side effects include allergic reactions to the medications used, potential liver enzyme elevations indicating liver stress or damage, gastrointestinal discomfort like nausea or vomiting, mood swings including depression or anxiety symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My overall health is good, as confirmed by recent medical exams and tests.

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I have been diagnosed with opioid addiction for at least 6 months.

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My overall health is good, with no significant issues found in recent medical tests.

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I am between 18 and 65 years old and interested in relapse prevention treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have a severe addiction to alcohol or sedatives that would complicate medical detox.

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I use no more than 8 mg of buprenorphine up to 3 days a week, and haven't used it since starting XR-NTX.

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I am allergic to buprenorphine, naltrexone, naloxone, clonidine, or clonazepam.

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I need opioids for a painful condition or upcoming surgery.

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I do not have a severe illness like advanced heart or liver disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 20 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~20 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Proportion of participants receiving XR-naltrexone injections

Side effects data

From 2010 Phase 4 trial • 1269 Patients • NCT00315341

48%

infections and infestations

41%

investigations

33%

gastrointestinal disorders

24%

injury, poisoning, and procedural complications

23%

nasopharyngitis

20%

nervous system disorders

19%

musculoskeletal and connective tissue disorders

17%

psychiatric disorders

16%

general disorders and administration site conditions

14%

skin and subcutaneous tissue disorders

13%

alanine aminotransferase increased

12%

aspartate aminotransferase increased

12%

respiratory, thoracic, and mediastinal disorders

11%

gamma glutamyltransferase increased

11%

toothache

10%

headache

hospitalization

constipation

hyperhidrosis

back pain

influenza

vomiting

upper respiratory tract infection

weight increased

life-threatening

disability

100%

80%

60%

40%

20%

Study treatment Arm

Methadone

Buprenorphine/Nx

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Buprenorphine-naloxoneExperimental Treatment1 Intervention

Buprenorphine/naloxone 5.7 mg /1.4 mg/day sub-lingual tablets

Group II: PlaceboPlacebo Group1 Intervention

placebo sub-lingual tablet

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Buprenorphine/naloxone

2010

Completed Phase 4

~2460

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

New York State Psychiatric InstituteLead Sponsor

477 Previous Clinical Trials

153,848 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,543 Previous Clinical Trials

3,249,196 Total Patients Enrolled

Adam Bisaga, MDPrincipal InvestigatorNew York State Psychiatric Institute

6 Previous Clinical Trials

437 Total Patients Enrolled

Media Library

Buprenorphine/naloxone (Opioid Partial Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05011266 — Phase 2 & 3

Opioid Use Disorder Research Study Groups: Placebo, Buprenorphine-naloxone

Opioid Use Disorder Clinical Trial 2023: Buprenorphine/naloxone Highlights & Side Effects. Trial Name: NCT05011266 — Phase 2 & 3

Buprenorphine/naloxone (Opioid Partial Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05011266 — Phase 2 & 3

~97 spots leftby Jun 2026

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