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NCT03113409

Buprenorphine as Adjunct to Outpatient Induction Onto Vivitrol

Terminated Phase 2, PHASE3 Results posted Last updated 2 March 2022
What this trial tests

Phase 2, PHASE3 trial testing Buprenorphine in Opioid-use Disorder in 10 participants. Terminated before completion.

Timeline
1 June 2017
Primary endpoint
1 December 2020
1 December 2020

Quick facts

Lead sponsorNew York State Psychiatric Institute
PhasePhase 2, PHASE3
StatusTerminated
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment10
Start date1 June 2017
Primary completion1 December 2020
Estimated completion1 December 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

New York State Psychiatric Institute

Who can join

Adults 18 to 60, any sex, with Opioid-use Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Patients Who Receive the Second Injection of XR-NTX. Primary · 4 weeks after 1st injection

Percentage of patient who initiated Procedure 1 and completed the study receiving the 2nd injection of XR-NTX

GroupValue95% CI
Procedure 16

Sponsor's own description

The study will enroll 30 opioid-dependent participants into an open-label pilot outpatient study of methods to facilitate induction and stabilization onto XR-NTX. There will be three different methods of XR-NTX induction using increasing doses of oral naltrexone and buprenophine.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Buprenorphine

Trials testing the same drug.

Other recruiting trials for Opioid-use Disorder

Currently open trials in the same condition.

Other New York State Psychiatric Institute trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03113409.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing