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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 weeks
Awards & highlights

COMBO Trial 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.Check my eligibility
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.See study design
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.

COMBO Trial 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.

COMBO Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants receiving XR-naltrexone injections

Side effects data

From 2010 Phase 4 trial • 1269 Patients • NCT00315341
39%
infections and infestations
30%
investigations
27%
gastrointestinal disorders
21%
nervous system disorders
19%
musculoskeletal and connective tissue disorders
18%
injury, poisoning, and procedural complications
16%
psychiatric disorders
16%
nasopharyngitis
14%
headache
11%
general disorders and administration site conditions
11%
respiratory, thoracic, and mediastinal disorders
11%
alanine aminotransferase increased
10%
skin and subcutaneous tissue disorders
10%
aspartate aminotransferase increased
7%
constipation
7%
toothache
7%
back pain
6%
gamma glutamyltransferase increased
5%
influenza
5%
hospitalization
4%
upper respiratory tract infection
4%
vomiting
2%
hyperhidrosis
1%
weight increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Buprenorphine/Nx
Methadone

COMBO 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?

New York State Psychiatric InstituteLead Sponsor
475 Previous Clinical Trials
153,727 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,465 Previous Clinical Trials
2,618,453 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers are needed for this research project?

"That is correct, the trial indicated on clinicaltrials.gov is looking for new patients to enroll. The date range listed shows that this study was posted on 8/1/2022 and last updated on 8/11/2022. They are seeking a total of 180 participants from 1 site."

Answered by AI

Is this clinical trial open to people who are not yet 40 years old?

"This clinical trial is only eligible for people aged 18 to 65. Out of the 1,341 total trials, 344 are for individuals below 18 years old and 997 are for senior citizens."

Answered by AI

Who would be an eligible candidate for this clinical research?

"The prerequisites for participants of this clinical trial include active opioid use disorder and being between 18-65 years old. Currently, the team is looking to enroll 180 individuals."

Answered by AI

Are there any open slots in this research project for new participants?

"The clinicaltrials.gov website confirms that this study is open for recruitment. This trial was first announced on August 1st, 2022 and the most recent update was on August 11th, 2022. Currently, 180 people are needed to take part in this study at a single location."

Answered by AI

What is Buprenorphine/naloxone's most popular therapeutic application?

"Buprenorphine/naloxone is used as an intervention for opioids most frequently, but it has also been taken to manage pruritus, pain, and septic shock."

Answered by AI

Could you please provide some context for this Buprenorphine/naloxone clinical trial in relation to others like it?

"Currently, there are 60 ongoing studies investigating the efficacy of buprenorphine/naloxone. Of those active studies, 14 are in Phase 3. The majority of clinical trials for this medication are taking place in White River Junction, Vermont; however, 243 different locations across the globe are running trials for this treatment."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Efficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder
Adam Bisaga 2022. "Efficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05011266.
All > Probuphine
~98 spots leftby Jun 2026
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