52 completed, 2 terminated, 2 unknown. 13 Phase 1, 12 Phase 2, 12 Phase 4, 6 Phase 3, 3 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 13 | Completed 13 |
| Phase 2 | 12 | Completed 12 |
| Phase 4 | 12 | Completed 11, Terminated 1 |
| Phase 3 | 6 | Completed 6 |
| Not applicable | 3 | Completed 2, Unknown 1 |
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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 |
|---|---|---|---|---|---|---|
| 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 |
| Proof of Concept and Dose-ranging Study of INDV-2000 in Individuals With Moderate to Severe Opioid Use Disorder INDV-2000, Placebo - Opioid Use Disorder | Phase 2 | Completed | Indivior Inc. | 300 | 2024-06-10 | 2025-12-16 |
| Evaluating the SUBLOCADE Treatment Exit Strategy Opioid Use Disorder | Completed | Indivior Inc. | 12 | 2023-11-24 | 2026-01-22 | |
| SUBLOCADE Long-term Outcomes Opioid Use Disorder | Completed | Indivior Inc. | 480 | 2023-08-31 | 2025-10-16 | |
| Single Dose Study of [14C]-IDV184001AN ([14C]-IDV184001) in Healthy Adult Male Participants [14C]IDV184001AN - Opioid Use Disorder | Phase 1 | Completed | Indivior Inc. | 7 | 2023-07-10 | 2025-02-13 |
| Study of Potential CYP3A4 Induction by INDV-2000 in Healthy Adults INDV-2000, Midazolam - Healthy | Phase 1 | Completed | Indivior Inc. | 20 | 2023-03-16 | 2024-05-28 |
| 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 |
| Extended-release Injectable Buprenorphine for Individuals at High Risk of Overdose Opioid-Use Disorder, Opioid Overdose | Unknown | BC Centre on Substance Use | 40 | 2022-10-17 | 2022-11-17 | |
| Study to Assess Repeated Doses of INDV-2000 in Healthy Volunteers and in Treatment Seeking Individuals With Opioid Use Disorder INDV-2000, Placebo, SUBOXONE® sublingual film - Healthy Volunteer, Opioid-use Disorder | Phase 1 | Completed | Indivior Inc. | 64 | 2022-08-17 | 2024-08-21 |
| 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 |
| An Observational Study of Environmental and Socioeconomic Factors in Opioid Recovery - Long Term Online survey only - Opioid Use Disorder | Terminated | Indivior Inc. | 216 | 2020-09-20 | 2022-10-07 | |
| INDV-2000 First in Human INDV-2000, Placebo - Opioid Dependence | Phase 1 | Completed | Indivior Inc. | 73 | 2020-07-06 | 2024-05-16 |
| 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 |
| Safety, Tolerability, Pharmacokinetics and Efficacy of 180 mg Subcutaneous Risperidone From 6 mg Oral Risperidone PERSERIS, Risperidone - Schizophrenia | Phase 4 | Completed | Indivior Inc. | 69 | 2019-06-28 | 2021-07-07 |
| Evaluation of Long-term Buprenorphine Plasma Exposure Blood sample collection, Urine sample collection - Opioid-use Disorder | Completed | Indivior Inc. | 53 | 2019-02-19 | 2020-08-21 | |
| Buprenorphine-Fentanyl Interaction Study Buprenorphine Injectable Solution - Part A, Placebo - Parts A + B, Fentanyl - Part A - Healthy, Opioid Use | Phase 1 | Completed | Indivior Inc. | 22 | 2018-03-22 | 2025-03-13 |
| Study of a Novel Subcutaneous Depot Formulation of Buprenorphine INDV-6200, Placebo, SL Buprenorphine - Opioid-use Disorder | Phase 1 | Completed | Indivior Inc. | 12 | 2017-09-20 | 2019-03-04 |
| A Phase 1 Bioavailability Study of Arbaclofen Placarbil Modified Release Formulations in Healthy Volunteers Arbaclofen Placarbil SR, Arbaclofen Placarbil MR Prototype A, Arbaclofen Placarbil MR Prototype B - Healthy Volunteers | Phase 1 | Completed | Indivior Inc. | 40 | 2017-01-24 | 2018-01-17 |
| Open-Label Treatment Extension Study RBP-6000 - Opioid Use Disorder, Opioid-related Disorders | Phase 3 | Completed | Indivior Inc. | 208 | 2016-08-17 | 2018-11-29 |
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Opioid-Related Disorders (34) · Schizophrenia (7) · Substance-Related Disorders (7) · Heroin Dependence (2) · Opiate Overdose (2) · Pain (2) · Agnosia (1) · Alcohol-Induced Disorders (1) · Alcoholic Intoxication (1) · Alcoholism (1) · Behavior, Addictive (1) · Cocaine-Related Disorders (1) · Gastroesophageal Reflux (1) · Hepatitis C (1) · Hepatitis C, Chronic (1)
Buprenorphine (21) · Buprenorphine, Naloxone Drug Combination (15) · Naloxone (6) · Risperidone (6) · Sublocade (5) · Sugars (2) · Cocaine (1) · Drugs, Generic (1) · Eudragit RS (1) · Hydrocodone (1) · Hydromorphone (1) · Methadone (1) · Midazolam (1) · Morphine (1) · Naltrexone (1)
United States (41) · Canada (4) · Austria (2) · Sweden (2) · United Kingdom (2) · Australia (1) · Czechia (1) · France (1) · Germany (1) · Netherlands (1) · Taiwan (1)
Bradley D Vince, DO (2) · Ashley Huston, PMP (1) · Bernd Weber, Dr. (1) · Chaim Jellinek (1) · Charlotte Rechenmacher, Dr (1) · Claus Schubert, Dr (1) · Danielle Armas, MD (1) · David Walling (1) · Donald R. Jasinski, MD (1) · Edith Issler, Dr. (1)
PMID 35287034, PMID 37657559, PMID 36467036, PMID 37936553, PMID 25603822, PMID 26650971, PMID 30792007, PMID 32187112, PMID 32920647, PMID 34551218, PMID 34551219, PMID 34551220, PMID 34794061, PMID 35085249, PMID 35709575, PMID 36001871, PMID 37267169, PMID 38042801, PMID 38388986, PMID 39543001, PMID 41085986, PMID 41405885
UG3DA050308 (3), 2016 (1), 2017 (1), R01DA035207 (1)