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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

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 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
9%
hospitalization
9%
constipation
7%
hyperhidrosis
7%
back pain
7%
influenza
6%
vomiting
5%
upper respiratory tract infection
5%
weight increased
1%
life-threatening
1%
disability
100%
80%
60%
40%
20%
0%
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

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA) (DA038095)UNKNOWN
1 Previous Clinical Trials
13 Total Patients Enrolled
New York State Psychiatric InstituteLead Sponsor
479 Previous Clinical Trials
153,650 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,606 Previous Clinical Trials
3,329,689 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
~83 spots leftby Jun 2026
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