Community Studies of Long Acting Buprenorphine (CoLAB) (CoLAB)

March 2, 2020 updated by: Marianne Byrne, The University of New South Wales

An Open-label, Multicentre, Single-arm Trial of Monthly Injections of Depot Buprenorphine in People With Opioid Dependence

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Opioid agonist treatment (OAT) is effective for opioid dependence and newer extended-release buprenorphine (BUP-XR) injections represent a significant development. The Community Long-Acting Buprenorphine (CoLAB) study aims to evaluate client outcomes among people with opioid dependence receiving 48 weeks of BUP-XR treatment, and examines the implementation of BUP-XR in diverse community healthcare settings in Australia.

The CoLAB study is a prospective single-arm, multicentre, open-label trial of monthly BUP-XR injections in people with opioid dependence. Participants are being recruited from a network of general practitioner and specialist drug treatment services located in the states of New South Wales, Victoria and South Australia in Australia. Following a minimum 7 days on 8-32mg of sublingual buprenorphine (+/- naloxone), participants will receive monthly subcutaneous BUP-XR injections administered by a healthcare practitioner at intervals of 28 days (-2/+14 days). The primary endpoint is participant retention in treatment at 48 weeks after treatment initiation. Secondary endpoints will evaluate dosing schedule variations, craving, withdrawal, substance use, health and well-being, and client-reported treatment experience. Qualitative and costing sub-studies will examine implementation barriers and facilitators at the client and provider level.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Darlinghurst, Australia, 2010
        • Rankin Court Treatment Centre, St Vincent's Hospital Sydney
    • New South Wales
      • Newcastle, New South Wales, Australia, 2300
        • Drug and Alcohol Services, Hunter New England Local Health District
      • Saint Leonards, New South Wales, Australia, 2065
        • Drug and Alcohol Services, North Sydney Local Health District
    • South Australia
      • Morphett Vale, South Australia, Australia, 5162
        • Drug and Alcohol Services, South Australia (DASSA)
    • Victoria
      • Footscray, Victoria, Australia, 3011
        • Western Health Drug Services, Footscray Hospital
      • Frankston, Victoria, Australia, 3199
        • Frankston Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

The study population is individuals diagnosed with opioid dependence who are currently receiving sublingual buprenorphine treatment at participating drug and alcohol services, express interest in receiving depot buprenorphine injections and are deemed suitable for treatment with RBP-6000 by the Investigator.

Inclusion criteria

To be eligible for the study, participants must meet all of the following inclusion criteria:

  1. Voluntarily signed the informed consent form
  2. Aged 18 to 65 years
  3. Opioid-dependent (ICD-10) currently receiving treatment
  4. Has been receiving 8-32mg sublingual buprenorphine +/- naloxone tablets/film for at least 7 days
  5. 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)

Exclusion criteria

Participants who meet any of the exclusion criteria are not to be enrolled in this study:

  1. Currently lactating or pregnant, or of childbearing potential and not willing to avoid becoming pregnant during the study
  2. History or presence of allergic or adverse response (including rash or anaphylaxis) to buprenorphine or the ATRIGEL® Delivery System
  3. 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)
  4. Subjects who are currently participating in any other clinical study involving investigational medication(s)
  5. Inability or unwillingness to provide informed consent or abide by the requirements of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Depot buprenorphine arm
All participants will receive monthly injections of depot buprenorphine (RBP-6000, Sublocade)
Drug: RBP-6000
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.
Other Names:
  • Sublocade

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant retention
Time Frame: Retention in dosing schedule at 48 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
BUP-XR treatment retention and engagement in ongoing clinical care
Time Frame: 48 weeks
To examine BUP-XR treatment retention and engagement in ongoing clinical care at 48 weeks ortion of participants retained in treatment at 48 weeks following initiation of monthly depot buprenorphine injections and engaged in ongoing clinical care. Treatment retention is defined as remaining on active depot buprenorphine medication AND completing a clinical assessment at 48 weeks.
48 weeks
Changes in opioid withdrawal
Time Frame: 48 weeks
Change in opioid withdrawal assessed by clinical opioid withdrawal scale (COWS) and subjective opioid withdrawal scale (SOWS)
48 weeks
Changes in client-reported opioid craving
Time Frame: 48 weeks
Change in client-reported opioid craving assessed by opioid craving scale
48 weeks
Changes in client-reported drug use
Time Frame: 48 weeks
Change in client-reported use of opioids and other drugs, assessed by the Australian Treatment Outcomes Profile (ATOP) instrument
48 weeks
BUP-XR dosing schedule adherence
Time Frame: 48 weeks
To evaluate client utilisation of buprenorphine medication during the study, including BUP-XR dose variation, adherence with dosing schedule, and dose supplementation
48 weeks
BUP-XR safety and tolerability
Time Frame: 48 weeks
To evaluate treatment safety and tolerability by monitoring adverse events, and events of clinical interest such as drug-drug interactions and pain management in clients treated with BUP-XR
48 weeks
Changes in client-report pain and enjoyment
Time Frame: 48 weeks
To describe client-reported changes to pain and enjoyment of life, assessed by the Pain, Enjoyment, General Activity (PEG) scale
48 weeks
Demographic factors associated with treatment retention
Time Frame: 48 weeks
To evaluate demographic factors (gender, age, education) associated with treatment retention, assessed by demographic questionnaire
48 weeks
Client treatment satisfaction score
Time Frame: 48 weeks
Client-reported treatment satisfaction assessed by the Treatment Questionnaire for Medication Satisfaction (TQSM)
48 weeks
BUP-XR treatment costs
Time Frame: 48 weeks
Costs to services delivering BUP-XR assessed by site-reported expenses and time and motion study
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of New South Wales

Investigators

  • Principal Investigator: Michael Farrell, National Drug and Alcohol Centre, University of New South Wales

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2019

Primary Completion (Anticipated)

November 1, 2020

Study Completion (Anticipated)

March 30, 2021

Study Registration Dates

First Submitted

January 16, 2019

First Submitted That Met QC Criteria

January 16, 2019

First Posted (Actual)

January 18, 2019

Study Record Updates

Last Update Posted (Actual)

March 5, 2020

Last Update Submitted That Met QC Criteria

March 2, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CoLAB1801

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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