Opioid Dependence Clinical Trial
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.
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.
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