CLINICAL TRIALS PROFILE FOR SUBLOCADE
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All Clinical Trials for SUBLOCADE
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT03604159 ↗ | XRB vs. SLB in Jail and at Re-entry: Pilot, Proof of Concept | Completed | NYC Health + Hospitals | Phase 4 | 2019-06-24 | This is a pilot proof-of-concept randomized controlled trial, open-label and unblinded, examining the feasibility and acceptability of Buprenorphine extended-release vs. daily sublingual buprenorphine-naloxone for the treatment of opioid use disorder in jail and at community re-entry. |
| NCT03604159 ↗ | XRB vs. SLB in Jail and at Re-entry: Pilot, Proof of Concept | Completed | New York University School of Medicine | Phase 4 | 2019-06-24 | This is a pilot proof-of-concept randomized controlled trial, open-label and unblinded, examining the feasibility and acceptability of Buprenorphine extended-release vs. daily sublingual buprenorphine-naloxone for the treatment of opioid use disorder in jail and at community re-entry. |
| NCT03604159 ↗ | XRB vs. SLB in Jail and at Re-entry: Pilot, Proof of Concept | Completed | NYU Langone Health | Phase 4 | 2019-06-24 | This is a pilot proof-of-concept randomized controlled trial, open-label and unblinded, examining the feasibility and acceptability of Buprenorphine extended-release vs. daily sublingual buprenorphine-naloxone for the treatment of opioid use disorder in jail and at community re-entry. |
| NCT03744663 ↗ | Long Acting Buprenorphine Injection Compared to Sublingual Buprenorphine/Naloxone Films | Suspended | Wake Forest University Health Sciences | Phase 2 | 2022-06-01 | While substance use disorders have been found to have relapse rates on part with other chronic illnesses such as hypertension and asthma long term abstinence remains elusive for many. The FDA has recently approve a long acting subcutaneous injectable formulation of buprenorphine. This study aims to determine the feasibility of enrolling and randomizing patients seeking treatment at an outpatient substance abuse clinic to buprenorphine/naloxone films which dissolve under the tongue vs. long acting buprenorphine injection with all other treatment aspects held constant. The study also aims to determine the effectiveness of monthly injections of Sublocade® compared to daily oral Suboxone® SL therapy in the treatment of moderate to severe opioid use disorder after twenty-four weeks of treatment. |
| NCT03809143 ↗ | Community Studies of Long Acting Buprenorphine (CoLAB) | Active, not recruiting | The University of New South Wales | Phase 3 | 2019-05-22 | Despite research demonstrating the efficacy of buprenorphine (BPN), effectiveness in real-world settings has been limited by shorter retention than for methadone, and the need for daily or near-daily dosing (frequently supervised in Australia). Newly developed sustained-release BPN formulations could provide rapid onset and sustained release of BPN. Current formulations include six-monthly implants, and once-weekly or once-monthly injections, removing the need for frequent clinic or pharmacy attendance. Improved medication adherence may result in improved patient outcomes and fewer unintended consequences such as diversion, but more data are needed in real-world settings. These innovations have the potential to dramatically change the treatment settings and options for people who are opioid dependent. The study aims to evaluate the patient outcomes following the implementation of a monthly BPN depot injection for the treatment of opioid dependence in community-based treatment settings with a focus on opioid and other illicit drug use, adherence and retention, and participants' experiences of the implementation. |
| NCT03818399 ↗ | Virginia Opioid Overdose Treatment InitiatVE | Terminated | Indivior Inc. | Phase 3 | 2019-01-04 | This is a Phase 3b, open-label study in patients that present to the ED for an opioid OD and receive treatment with an opioid antagonist. The study is designed to determine effect of SUBLOCADE on repeat overdose and death compared to historical control data. The study will assess subjects that receive acute administration of SUBOXONE sublingual film in the Emergency Department (ED) followed by SUBLOCADE administration in the ED and referral to an affiliated outpatient treatment clinic, compared to historical control data from electronic health records. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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