Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05011266 · ClinicalTrials.gov registry record · Phase 2
Efficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder
A Phase 2 study of Opioid Use Disorder, sponsored by New York State Psychiatric Institute.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 180
- Enrollment target
- 2
- Study locations
NCT05011266: Recruiting Phase 2 study of Opioid Use Disorder, sponsored by New York State Psychiatric Institute.
NCT05011266 is a Phase 2 study of Opioid Use Disorder that is actively recruiting participants, run by New York State Psychiatric Institute. The registered enrollment target is 180 participants, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05011266, a Phase 2 study of Opioid Use Disorder, is actively recruiting participants, sponsored by New York State Psychiatric Institute.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 180 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study will evaluate the effectiveness of a new pharmacological approach to increase efficacy of treatment with extended release naltrexone (XR-naltrexone) for individuals with opioid use disorder by combining it with buprenorphine-naloxone. This is a two arm, double-blind, placebo-controlled study to examine whether addition of buprenorphine-naloxone will improve treatment retention, reduce opioid craving, and improve mood over 24 weeks of treatment with extended release naltrexone (XR-naltrexone) administered every four weeks for a total of 6 injections. The NYSPI site, which provides study oversight (no direct participant involvement) is currently paused and has been paused since an institutional pause on human subjects research began in June, 2023. The U.S. Department of Health and Human Services (HHS) Office of Human Research Protections (OHRP) issued an FWA restriction on NYSPI research that also included a pause of human subjects research as of June 23, 2023.
Primary Outcome
Proportion of patients successfully retained to receive six consecutive XR-naltrexone injection.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Buprenorphine/naloxone
Study Locations (2)
Maryland
- Avery Road Treatment Center (ARTC) - Rockville
New York
- Stars/Nyspi - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2023-04-18 |
| Est. Completion | 2026-06-01 |
| Phase | Phase 2 |
What NCT05011266 shows while recruiting
NCT05011266 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Opioid Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05011266 reports a single indexed study location in Maryland, New York.
Frequently Asked Questions
What is clinical trial NCT05011266 about?
NCT05011266 is a clinical study titled "Efficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder". This study will evaluate the effectiveness of a new pharmacological approach to increase efficacy of treatment with extended release naltrexone (XR-naltrexone) for individuals with opioid use disorder by combining it with buprenorphine-naloxone. This is a two arm, double-blind, placebo-controlled st...
What is the current status of trial NCT05011266?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 2023-04-18. Estimated completion is 2026-06-01.
What conditions does trial NCT05011266 study?
This clinical trial studies the following conditions: Opioid Use Disorder.
What interventions are being tested in trial NCT05011266?
The interventions under investigation include: Placebo (DRUG), Buprenorphine/naloxone (DRUG).
Who is sponsoring clinical trial NCT05011266?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05011266 being conducted?
This trial has 2 study locations across Maryland, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Opioid Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05011266's enrollment target sits among peer trials
180 100th of 257 higher than 155 of 257 other Opioid Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders
RECRUITING · Phase 2
-
Remotely Observed Methadone Evaluation II
RECRUITING · Phase 2
-
Suvorexant as an Adjunct to Buprenorphine in Persons Who Use Fentanyl
RECRUITING · Phase 2
-
Identifying Optimal Buprenorphine Dosing for Opioid Use Disorder Treatment and Prevention of Overdose
RECRUITING · Phase 2
-
Ketamine for Opioid Use Disorder
RECRUITING · Phase 2
-
Brief Digitally-Enhanced Intervention for Reducing Alcohol Use During MOUD
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01558804 · 180 participants
GRoup A StrePtococcus
- NCT02932176 · 180 participants
Machine Learning for Handheld Vascular Studies
- NCT03384563 · 180 participants · Phase 4
Effect of Dexmedetomidine on the Minimum Alveolar Concentration of Sevoflurane
- NCT03423628 · 180 participants · Phase 1
A Study to Assess the Safety and Tolerability of AZD1390 Given With Radiation Therapy in Patients With Brain Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI