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Opioid DependencePhase 3CoLABNCT03809143

Community Studies of Long Acting Buprenorphine (CoLAB)

A Phase 3 study testing RBP-6000 in people with Opioid Dependence, run by The University of New South Wales at 6 sites in Australia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Opioid Dependence
What is being tested?
RBP-6000
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
6 sitesAustralia
Study dates
22 May 2019to 30 Mar 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Australia6 sites

  • Rankin Court Treatment Centre, St Vincent's Hospital Sydney

    Darlinghurst, 2010

  • Western Health Drug Services, Footscray Hospital

    Footscray, Victoria, 3011

  • Frankston Healthcare

    Frankston, Victoria, 3199

  • Drug and Alcohol Services, South Australia (DASSA)

    Morphett Vale, South Australia, 5162

  • Drug and Alcohol Services, Hunter New England Local Health District

    Newcastle, New South Wales, 2300

  • Drug and Alcohol Services, North Sydney Local Health District

    Saint Leonards, New South Wales, 2065

Other trials in Australia

About this study

Official title: 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.

Read the 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.

Being tested
RBP-6000
Medical subject headings
Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RBP-6000Drug

    Also called Sublocade

    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.

Study groups in NCT03809143
Study groupRoleWhat they receive
Depot buprenorphine armExperimentalAll participants will receive monthly injections of depot buprenorphine (RBP-6000, Sublocade)
Receives: Drug: RBP-6000

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Retention in dosing schedule at 48 weeks

Secondary outcomes (10)

  1. BUP-XR treatment retention and engagement in ongoing clinical care

    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.

    Measured: 48 weeks

  2. Changes in opioid withdrawal

    Change in opioid withdrawal assessed by clinical opioid withdrawal scale (COWS) and subjective opioid withdrawal scale (SOWS)

    Measured: 48 weeks

  3. Changes in client-reported opioid craving

    Change in client-reported opioid craving assessed by opioid craving scale

    Measured: 48 weeks

  4. Changes in client-reported drug use

    Change in client-reported use of opioids and other drugs, assessed by the Australian Treatment Outcomes Profile (ATOP) instrument

    Measured: 48 weeks

  5. BUP-XR dosing schedule adherence

    To evaluate client utilisation of buprenorphine medication during the study, including BUP-XR dose variation, adherence with dosing schedule, and dose supplementation

    Measured: 48 weeks

  6. BUP-XR safety and tolerability

    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

    Measured: 48 weeks

  7. Changes in client-report pain and enjoyment

    To describe client-reported changes to pain and enjoyment of life, assessed by the Pain, Enjoyment, General Activity (PEG) scale

    Measured: 48 weeks

  8. Demographic factors associated with treatment retention

    To evaluate demographic factors (gender, age, education) associated with treatment retention, assessed by demographic questionnaire

    Measured: 48 weeks

  9. Client treatment satisfaction score

    Client-reported treatment satisfaction assessed by the Treatment Questionnaire for Medication Satisfaction (TQSM)

    Measured: 48 weeks

  10. BUP-XR treatment costs

    Costs to services delivering BUP-XR assessed by site-reported expenses and time and motion study

    Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2019
  2. Study start22 May 2019
  3. Primary completion1 Nov 2020 (estimated)
  4. Study completion30 Mar 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03809143
Sponsor's protocol ID
CoLAB1801
Acronym
CoLAB
Status last verified
Mar 2020
First submitted
16 Jan 2019
Last updated
5 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gendera S, Rhodes T, Treloar C. The 'knowing' body in the becoming of buprenorphine depot treatment: A qualitative study. Int J Drug Policy. 2025 Dec;146:105043. doi: 10.1016/j.drugpo.2025.105043. Epub 2025 Nov 14.

    PubMed 41240750

  • Gendera S, Lancaster K, Rhodes T, Treloar C. Making long-acting treatment work: Tracing connections with extended-release buprenorphine depot through time. Drug Alcohol Rev. 2025 Mar;44(3):829-841. doi: 10.1111/dar.14021. Epub 2025 Feb 17.

    PubMed 39957328

  • Lancaster K, Gendera S, Treloar C, Rhodes T, Shahbazi J, Byrne M, Nielsen S, Degenhardt L, Farrell M. Tinkering with care: Implementing extended-release buprenorphine depot treatment for opioid dependence. Int J Drug Policy. 2024 Apr;126:104359. doi: 10.1016/j.drugpo.2024.104359. Epub 2024 Feb 20.

    PubMed 38382354

  • 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.

    PubMed 34736130

  • 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.

    PubMed 32737087

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RBP-6000 in people with Opioid Dependence, run by The University of New South Wales at 6 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participant retention (time frame: Retention in dosing schedule at 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03809143, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2020.

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