Buprenorphine and XR-Naltrexone for Opioid Use Disorder
This study is looking at a new way to treat Opioid Use Disorder (OUD) by combining two medicines: buprenorphine/naloxone and extended-release naltrexone (XR-naltrexone). Researchers want to see if adding buprenorphine/naloxone to XR-naltrexone treatment can help people stay in treatment longer, reduce cravings for opioids, and improve their mood. You might be able to join if you are between 18 and 65 years old, have OUD, and are interested in this type of treatment. The main goal is to see how many participants receive all their XR-naltrexone injections over 20 weeks. The current status of this study is unclear.
- Study design
- This is a double-blind study, meaning neither you nor your doctor will know if you are receiving buprenorphine/naloxone or a placebo (an inactive substance). It aims to include 180 participants and compares two groups of people.
- What's involved
- You would receive XR-naltrexone injections every four weeks for a total of six injections, along with weekly medication management, over 24 weeks. The study may also provide detoxification and a first XR-naltrexone injection if needed.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main outcome is measured at 20 weeks, which suggests follow-up during and potentially shortly after this period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05011266
Efficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder
Recruiting
PHASE2Ages 18–65InterventionalTreatmentNew York State Psychiatric InstituteInvestigator-initiated
~180 participants
Updated 2026-05-19 on ClinicalTrials.gov
What's tested:Buprenorphine/naloxonePlacebo
At a glance
Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants receiving XR-naltrexone injections
Measured over 20 weeks
Conditions
Where it's being run
2 sites across 2 statesMaryland1
New York1
Study leadership
- Adam Bisaga, MD · PRINCIPAL_INVESTIGATOR · New York State Psychiatric Institute
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Individuals between the ages of 18-65 (inclusive) interested in antagonist-based relapse prevention treatment
Meets current DSM-5 criteria for current opioid use disorder of at least six months duration supported by urine toxicology positive for opioids OR positive naloxone challenge (defined by 3-point increase in COWS) if seeking detoxification and XR-NTX induction OR confirmed recent detoxification treatment for opioids.
In otherwise good health based on complete medical history, physical examination, vital signs measurement, ECG, and laboratory tests (hematology, blood chemistry, urinalysis) with no clinically significant abnormalities
Participants who completed detoxification and received XR-NTX are eligible for the study. Participants may be enrolled up to 2 weeks following an initial XR-NTX injection given in any outside research or community-based treatment setting (inpatient, outpatient residential).
Seeking treatment for opioid use disorder, willing to accept treatment with XR-NTX and, in the judgment of the treating physician, is a good candidate for naltrexone-based treatment.
Voluntarily seeking treatment for opioid use disorder.
Able to give written informed consent to participate in the study and showing a thorough understanding of the difference between agonist and antagonist-based treatment.
Exclusion
Methadone maintenance within 2 weeks of XR-NTX induction or any use of methadone in the week prior to XR-NTX induction
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 for no more than 3 days per week). If consenting after initial XR-NTX injection, any use of buprenorphine since XR-NTX induction is exclusionary.
Serious medical, psychiatric or substance use disorder that, in the opinion of the study physician, would make a detoxification and naltrexone initiation, or maintenance treatment with XR-NTX in combination with buprenorphine, hazardous (relative contraindications) or requires a different level of care. Examples include:
AST/ALT \> 3x normal limit
Pregnancy, lactation, or a plan of becoming pregnant. Women need to have negative blood pregnancy test at screening and agree to practice dual contraceptives.
Physiological dependence on alcohol or sedative-hypnotics with impending withdrawal. Other substance use diagnoses are not exclusionary.
History of allergic or adverse reaction to buprenorphine, naltrexone, naloxone, clonidine, or clonazepam.
Painful medical condition that requires ongoing opioid analgesia or anticipated surgery necessitating opioid medications.
Individuals above 60 with possible early cognitive decline or other neurodegenerative conditions as evidenced by a score of less than 25 on a Mini Mental Status Exam screen.
Participants who had 30 or more opioid-free days prior to randomization will not be eligible.
Participants more than 2 weeks following an initial XR-NTX injection (given in any outside research or community-based treatment setting, for example inpatient, outpatient residential).
What this trial measures
- Proportion of participants receiving XR-naltrexone injections20 weeks
Proportion of patients successfully retained to receive six consecutive XR-naltrexone injection.