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Extended-release Pharmacotherapy for Opioid Use Disorder

NCT05164549 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 342

Last updated 2024-01-19

No results posted yet for this study

Summary

The primary objective is a clinical superiority effectiveness contrast to standard of care. Reported following SPIRIT and CONSORT standards, the study will determine whether extended-release injectable depot Buprenorphine (XR-Bup) maintenance therapy for OUD over six months is clinically superior to standard-of-care, oral medication (sublingual Buprenorphine \[SL-Bup\] or oral methadone \[Met\]; together: Bup/Met)

Conditions

  • Opiate Substitution Treatment

Interventions

DRUG

Buprenorphine Injectable Product

Investigational Medicinal Product

DRUG

Methadone

Standard of Care

DRUG

Buprenorphine

Standard of Care

Sponsors & Collaborators

  • South London and Maudsley NHS Foundation Trust

    collaborator OTHER

  • Greater Manchester Mental Health NHS Foundation Trust

    collaborator OTHER

  • Northumberland, Tyne and Wear NHS Foundation Trust

    collaborator OTHER

  • Birmingham and Solihull Mental Health NHS Foundation Trust

    collaborator OTHER

  • NHS Tayside

    collaborator OTHER_GOV

  • Bangor University

    collaborator OTHER

  • King's College London

    lead OTHER

Principal Investigators

  • Mike Kelleher, Dr · South London and Maudsley NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-06
Primary Completion
2022-04-29
Completion
2023-03-01
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05164549 on ClinicalTrials.gov