Community Studies of Long Acting Buprenorphine (CoLAB)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Opioid Dependence

Intervention / Treatment
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* Drug: RBP-6000


Participation Criteria
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Eligibility Criteria
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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: 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) Exclusion criteria 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Depot buprenorphine arm<br>All participants will receive monthly injections of depot buprenorphine (RBP-6000, Sublocade) | Drug: RBP-6000<br>* 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.<br>* Other names: Sublocade;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 48 weeks | 
| Changes in opioid withdrawal | 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 | Change in client-reported opioid craving assessed by opioid craving scale | 48 weeks | 
| 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 | 48 weeks | 
| 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 | 48 weeks | 
| 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 | 48 weeks | 
| 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 | 48 weeks | 
| Demographic factors associated with treatment retention | To evaluate demographic factors (gender, age, education) associated with treatment retention, assessed by demographic questionnaire | 48 weeks | 
| Client treatment satisfaction score | Client-reported treatment satisfaction assessed by the Treatment Questionnaire for Medication Satisfaction (TQSM) | 48 weeks | 
| BUP-XR treatment costs | Costs to services delivering BUP-XR assessed by site-reported expenses and time and motion study | 48 weeks |