Community Studies of Long Acting Buprenorphine (CoLAB)

NCT03809143 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: CoLAB1801
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Opioid Dependence

Outcome Measures

Primary Outcomes (1)

• Participant retention

  To examine treatment retention at 48 weeks following initiation of monthly depot RBP-6000 buprenorphine injections in patients with opioid dependence transferred from a stable dose of sublingual buprenorphine.

  Retention in dosing schedule at 48 weeks

Secondary Outcomes (10)

• BUP-XR treatment retention and engagement in ongoing clinical care

  48 weeks

• Changes in opioid withdrawal

  48 weeks

• Changes in client-reported opioid craving

  48 weeks

• Changes in client-reported drug use

  48 weeks

• BUP-XR dosing schedule adherence

  48 weeks

Study Arms (1)

Depot buprenorphine arm

EXPERIMENTAL

All participants will receive monthly injections of depot buprenorphine (RBP-6000, Sublocade)

Drug: RBP-6000

Interventions

RBP-6000 DRUG

All study participants are scheduled to receive monthly subcutaneous injections of depot BPN, RBP-6000. RBP-6000 (BPN in the ATRIGEL® Delivery System) contains buprenorphine (200mg/mL) in the ATRIGEL® Delivery System, which provides sustained plasma level of BPN over a minimum of 28 days.

Also known as: Sublocade

Depot buprenorphine arm

Eligibility Criteria

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

You may qualify if:

• Voluntarily signed the informed consent form
• Aged 18 to 65 years
• Opioid-dependent (ICD-10) currently receiving treatment
• Has been receiving 8-32mg sublingual buprenorphine +/- naloxone tablets/film for at least 7 days
• Negative pregnancy test at screening and baseline in females of childbearing potential (please refer to Section 5.7 for long acting reversible contraceptive methods with efficacy considered to reasonably eliminate pregnancy potential)

You may not qualify if:

• Currently lactating or pregnant, or of childbearing potential and not willing to avoid becoming pregnant during the study
• History or presence of allergic or adverse response (including rash or anaphylaxis) to buprenorphine or the ATRIGEL® Delivery System
• Significant, medical or psychiatric conditions (other than opioid dependence), or other circumstances which, in the opinion of the Investigator, would compromise compliance with the protocol and/or patient safety. Specific conditions of interest include severe hepatic disease (Child-Pugh Class B), severe renal or respiratory disease, or severe cognitive impairment or psychiatric condition that impairs the ability to provide informed consent (e.g. psychosis, delirium, hypomania, severe depression or suicidal ideation)
• Subjects who are currently participating in any other clinical study involving investigational medication(s)
• Inability or unwillingness to provide informed consent or abide by the requirements of the study

Sponsors & Collaborators

• The University of New South Wales: lead

Study Sites (6)

Drug and Alcohol Services, Hunter New England Local Health District

Newcastle, New South Wales, 2300, Australia

Location

Drug and Alcohol Services, North Sydney Local Health District

Saint Leonards, New South Wales, 2065, Australia

Location

Drug and Alcohol Services, South Australia (DASSA)

Morphett Vale, South Australia, 5162, Australia

Location

Western Health Drug Services, Footscray Hospital

Footscray, Victoria, 3011, Australia

Location

Frankston Healthcare

Frankston, Victoria, 3199, Australia

Location

Rankin Court Treatment Centre, St Vincent's Hospital Sydney

Darlinghurst, 2010, Australia

Location

Related Publications (2)

• Farrell M, Shahbazi J, Byrne M, Grebely J, Lintzeris N, Chambers M, Larance B, Ali R, Nielsen S, Dunlop A, Dore GJ, McDonough M, Montebello M, Nicholas T, Weiss R, Rodgers C, Cook J, Degenhardt L; CoLAB study team. Outcomes of a single-arm implementation trial of extended-release subcutaneous buprenorphine depot injections in people with opioid dependence. Int J Drug Policy. 2022 Feb;100:103492. doi: 10.1016/j.drugpo.2021.103492. Epub 2021 Nov 1.

  PMID: 34736130 DERIVED

• Larance B, Byrne M, Lintzeris N, Nielsen S, Grebely J, Degenhardt L, Shahbazi J, Shanahan M, Lancaster K, Dore G, Ali R, Farrell M; CoLAB study team. Open-label, multicentre, single-arm trial of monthly injections of depot buprenorphine in people with opioid dependence: protocol for the CoLAB study. BMJ Open. 2020 Jul 31;10(7):e034389. doi: 10.1136/bmjopen-2019-034389.

  PMID: 32737087 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Sublocade

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Michael Farrell

  National Drug and Alcohol Centre, University of New South Wales

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Trials Manager, National Drug and Alcohol Research Centre

Study Record Dates

• First Submitted: January 16, 2019
• First Posted: January 18, 2019
• Study Start: May 22, 2019
• Primary Completion: November 1, 2020
• Study Completion: March 30, 2021
• Last Updated: March 5, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (6)