SUBLOCADE Rapid Initiation Extension Study

NCT04060654 | Completed Phase 4 Results FDA Drug

• 1 other identifier: INDV-6000-404
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

A single center, open-label SUBLOCADE treatment extension study in which up to 25 participants diagnosed with moderate to severe opioid use disorder (OUD) could be enrolled.

Conditions

Opioid Use Disorder, Severe; Opioid Use Disorder, Moderate

Outcome Measures

Primary Outcomes (1)

• Treatment Emergent Adverse Event (TEAE) Occurrence

  Study will report the number of participants with the occurrence of any TEAE during the treatment period.

  From time of informed consent at Day 1 until EOT, assessed up until Day 141

Study Arms (1)

SUBLOCADE

EXPERIMENTAL

All subjects will receive SUBLOCADE 300mg on Day 1, followed by injections every 4 weeks at a dose determined by the Investigator (either 100 mg or 300 mg) for up to 5 total injections

Drug: Sublocade

Interventions

Sublocade DRUG

SUBLOCADE to be administered approximately every 4 weeks per local standard of care

Also known as: Extended release buprenorphine

SUBLOCADE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed the informed consent form (ICF) and have the ability to comply with the requirements and restrictions listed therein.
• Completed the EOT Visit for the INDV-6000-403 Study.
• Is an appropriate candidate in the opinion of the Investigator or medically qualified sub-Investigator.

You may not qualify if:

• Subject compliance issues during participation in the INDV-6000-403 study which, in the opinion of the Investigator, could potentially compromise subject safety.
• Subjects who are unable, in the opinion of the Investigator or Indivior, to comply fully with the study requirements including those who are currently incarcerated or pending incarceration legal action.

Sponsors & Collaborators

• Indivior Inc.: lead

Study Sites (1)

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

Related Publications (1)

• Mariani JJ, Dobbins RL, Heath A, Gray F, Hassman H. Open-label investigation of rapid initiation of extended-release buprenorphine in patients using fentanyl and fentanyl analogs. Am J Addict. 2024 Jan;33(1):8-14. doi: 10.1111/ajad.13484. Epub 2023 Nov 8.

  PMID: 37936553 RESULT

MeSH Terms

Conditions

Opioid-Related Disorders; Lymphoma, Follicular

Interventions

Sublocade

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Limitations and Caveats

The goal of the study was to assess the longer term safety of an abbreviated initiation protocol of SUBLOCADE and to provide treatment to these individuals while they seek longer term care arrangements. The COVID-19 pandemic, which began during the study period, potentially affected participant's ability to attend clinic visits.

Results Point of Contact

• Title: Sunita Shinde
• Organization: Indivior Inc

sunita.shinde@indivior.com

804 379-1090

Study Officials

• Michael Hassman

  Hassman Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: After an initial injection of 300mg SUBLOCADE, all subjects will receive SUBLOCADE doses of 100mg or 300mg based on the medical judgement of the Investigator

Study Record Dates

• First Submitted: August 15, 2019
• First Posted: August 19, 2019
• Study Start: October 21, 2019
• Primary Completion: May 15, 2020
• Study Completion: May 15, 2020
• Last Updated: March 25, 2025
• Results First Posted: January 25, 2021

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)