10 completed, 6 withdrawn, 3 recruiting, 2 unknown. 13 Phase 4, 6 Phase 2, 4 Phase 3, 1 Phase 1.
Follow Sublocade: new trials by email Literature Review of Sublocade trials Research Report on Sublocade
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Comparing Outpatient Treatment Retention Among Individuals Using Fentanyl Randomized to Low-dose and Direct-to-inject Buprenorphine Initiation Injectable buprenorphine, Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets) - Opioid Use Disorder, Fentanyl | Phase 4 | Not yet recruiting | University of California, San Francisco | 50 | 2026-06-01 | 2026-03-13 |
| Symptom-Inhibited Naloxone Induction (SINI) for Buprenorphine Initiation: A Feasibility Trial Naloxone Hydrochloride 0.4 MG/ML, Buprenorphine hydrochloride and naloxone hydrochloride dihydrate sublingual tablet (2 mg/0.5 mg and 8 mg/2 mg), Buprenorphine extended-release injection (300 mg/1.5 mL) - Opioid Use Disorder | Phase 4 | Recruiting | Pouya Azar | 12 | 2026-04-29 | 2026-05-01 |
| Injectable Buprenorphine in Prison: A Preference Trial Brixadi (Injectable Buprenorphine), Sublocade - Opioid Use Disorder, Incarceration | Phase 4 | Recruiting | Lifespan | 60 | 2026-02-18 | 2026-05-15 |
| Assessing Optimal XRB Initiation Points in Jail Extended-Release Buprenorphine (XRB), Sublingual Buprenorphine (SLB) - Opioid Use Disorder | Phase 4 | Recruiting | NYU Langone Health | 50 | 2025-06-02 | 2026-08-07 |
| INDV-6001 Multiple-Dose Pharmacokinetic Study INDV-6001, Suboxone, Sublocade - Moderate to Severe Opioid Use Disorder | Phase 2 | Completed | Indivior Inc. | 123 | 2024-09-17 | 2026-03-16 |
| Assessing Optimal XR-Buprenorphine Initiation Points in Jail Extended-Release Buprenorphine Injection - Opioid Use Disorder | Phase 4 | Withdrawn | NYU Langone Health | 2023-11-01 | 2024-02-29 | |
| Evaluation of Buprenorphine Extended-Release Subcutaneous Injection at Alternative Injection Locations Buprenorphine Extended-Release Injection - Opioid Use Disorder | Phase 4 | Completed | Indivior Inc. | 132 | 2023-03-01 | 2025-01-07 |
| Monthly Versus Daily Buprenorphine Formulations for Treatment of Opiate Use Disorder Extended Release Subcutaneous Buprenorphine, Immediate Release Sublingual Buprenorphine - Moderate to Severe Opioid Use Disorder | Phase 4 | Unknown | Royal Victoria Hospital, Canada | 90 | 2022-12-01 | 2022-10-26 |
| Long Acting Buprenorphine Injection Compared to Sublingual Buprenorphine/Naloxone Films Suboxone® SL, Sublocade® - Opioid Use | Phase 2 | Withdrawn | Wake Forest University Health Sciences | 2022-06-01 | 2022-06-06 | |
| Combined Injectable Treatment for HIV and OUD Combined LAI Treatment: Cabenuva and Sublocade - Human Immunodeficiency Virus, Opioid Use Disorder | Phase 2 | Withdrawn | Rhode Island Hospital | 2022-04-01 | 2026-02-18 | |
| Buprenorphine Extended-Release Subcutaneous Injection (RBP-6000) in High-risk Users Transmucosal Buprenorphine, Extended-release Buprenorphine - Moderate to Severe Opioid-use Disorder | Phase 4 | Completed | Indivior Inc. | 785 | 2021-10-26 | 2026-02-06 |
| Integrated Outpatient Treatment of Opioid Use Disorder and Severe Injection Related Infections Buprenorphine and Outpatient Parenteral Antibiotic Therapy, Buprenorphine and standard of care antibiotic treatment - Drug Use, Opioid-use Disorder | Phase 2 | Completed | Laura Fanucchi | 71 | 2021-03-16 | 2026-04-28 |
| Virginia Opioid Treatment-Emergency Department SUBLOCADE - Opioid Use Disorder | Phase 3 | Withdrawn | Virginia Commonwealth University | 2021-01-01 | 2021-02-12 | |
| Extended-Release Buprenorphine vs. Sublingual Buprenorphine for the Treatment of Opioid Use Disorder extended-release buprenorphine (BXR), sublingual buprenorphine (BSL) - Opioid-use Disorder | Phase 2 | Completed | Frances R Levin | 33 | 2020-12-15 | 2026-08-27 |
| Long Acting Subcutaneous vs Short Acting Sublingual Buprenorphine in Pregnant and Lactating Women buprenorphine - Opioid Use Disorder | Phase 4 | Withdrawn | Ohio State University | 2020-02-21 | 2020-10-14 | |
| SUBLOCADE Rapid Initiation Extension Study Sublocade - Opioid Use Disorder, Severe, Opioid Use Disorder, Moderate | Phase 4 | Completed | Indivior Inc. | 17 | 2019-10-21 | 2025-03-25 |
| SUBLOCADE Rapid Initiation Study TM buprenorphine, SUBLOCADE - Opioid-use Disorder | Phase 4 | Completed | Indivior Inc. | 26 | 2019-08-29 | 2025-03-25 |
| Extended-release Pharmacotherapy for Opioid Use Disorder Buprenorphine Injectable Product, Methadone, Buprenorphine - Opiate Substitution Treatment | Phase 3 | Completed | King's College London | 342 | 2019-08-06 | 2024-01-19 |
| XRB vs. SLB in Jail and at Re-entry: Pilot, Proof of Concept Buprenorphine Extended Release, Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets) - Opioid Dependence | Phase 4 | Completed | NYU Langone Health | 52 | 2019-06-24 | 2022-01-11 |
| Community Studies of Long Acting Buprenorphine (CoLAB) RBP-6000 - Opioid Dependence | Phase 3 | Unknown | The University of New South Wales | 100 | 2019-05-22 | 2020-03-05 |
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Opioid-Related Disorders (18) · Acquired Immunodeficiency Syndrome (1) · Emergencies (1) · Endocarditis, Subacute Bacterial (1) · Infections (1) · Lymphoma, Follicular (1) · Substance-Related Disorders (1)
Indivior Inc. (5) · NYU Langone Health (3) · Virginia Commonwealth University (2) · Frances R Levin (1) · King's College London (1) · Laura Fanucchi (1) · Lifespan (1) · New York State Psychiatric Institute (1) · Ohio State University (1) · Pouya Azar (1) · Rhode Island Hospital (1) · Royal Victoria Hospital, Canada (1) · Stony Brook University (1) · The University of New South Wales (1) · University of California, San Francisco (1)
United States (16) · Canada (3) · Australia (1) · United Kingdom (1)
David Farabee, PhD (2) · Frederick G Moeller, MD (2) · David J Garry, DO (1) · Erin Barnes, MD (1) · Giulio DiDiodato, PhD (1) · Howard Hassman (1) · John Mariani, MD (1) · Joshua D Lee, MD, MSc (1) · Josiah D Rich, MD (1) · Kara Rood, MD (1) · Leslie W Suen, MD (1) · Michael Farrell (1) · Michael Hassman (1) · Mike Kelleher, Dr (1)
PMID 37936553, PMID 12738348, PMID 12954743, PMID 18559110, PMID 21270789, PMID 23531704, PMID 23617867, PMID 25022635, PMID 25569005, PMID 27687214, PMID 27799240, PMID 28669739, PMID 28742676, PMID 29226017, PMID 29473258, PMID 32737087, PMID 34495340, PMID 34736130, PMID 35093164, PMID 36001871, PMID 38045803, PMID 38382354, PMID 39543001, PMID 39957328, PMID 40645369, PMID 41085986, PMID 41240750, PMID 41405885, PMID 907
K23DA055695 (1), K23DA060329 (1), R01DA048892 (1), R21DA049037 (1)