Community Studies of Long Acting Buprenorphine (CoLAB)
- Registration Number
- NCT03809143
- Lead Sponsor
- The University of New South Wales
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Depot buprenorphine arm RBP-6000 All participants will receive monthly injections of depot buprenorphine (RBP-6000, Sublocade)
- Primary Outcome Measures
Name Time Method Participant retention 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.
- Secondary Outcome Measures
Name Time Method Changes in opioid withdrawal 48 weeks Change in opioid withdrawal assessed by clinical opioid withdrawal scale (COWS) and subjective opioid withdrawal scale (SOWS)
Changes in client-reported opioid craving 48 weeks Change in client-reported opioid craving assessed by opioid craving scale
BUP-XR safety and tolerability 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
BUP-XR treatment retention and engagement in ongoing clinical care 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.
Client treatment satisfaction score 48 weeks Client-reported treatment satisfaction assessed by the Treatment Questionnaire for Medication Satisfaction (TQSM)
Changes in client-reported drug use 48 weeks Change in client-reported use of opioids and other drugs, assessed by the Australian Treatment Outcomes Profile (ATOP) instrument
BUP-XR dosing schedule adherence 48 weeks To evaluate client utilisation of buprenorphine medication during the study, including BUP-XR dose variation, adherence with dosing schedule, and dose supplementation
Demographic factors associated with treatment retention 48 weeks To evaluate demographic factors (gender, age, education) associated with treatment retention, assessed by demographic questionnaire
Changes in client-report pain and enjoyment 48 weeks To describe client-reported changes to pain and enjoyment of life, assessed by the Pain, Enjoyment, General Activity (PEG) scale
BUP-XR treatment costs 48 weeks Costs to services delivering BUP-XR assessed by site-reported expenses and time and motion study
Trial Locations
- Locations (6)
Western Health Drug Services, Footscray Hospital
🇦🇺Footscray, Victoria, Australia
Drug and Alcohol Services, South Australia (DASSA)
🇦🇺Morphett Vale, South Australia, Australia
Frankston Healthcare
🇦🇺Frankston, Victoria, Australia
Drug and Alcohol Services, Hunter New England Local Health District
🇦🇺Newcastle, New South Wales, Australia
Drug and Alcohol Services, North Sydney Local Health District
🇦🇺Saint Leonards, New South Wales, Australia
Rankin Court Treatment Centre, St Vincent's Hospital Sydney
🇦🇺Darlinghurst, Australia