A Phase 3 interventional study of RBP-6000 in Opioid Dependence, sponsored by The University of New South Wales. Status unknown at 6 sites in Australia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-03-05.
Sponsored by The University of New South Wales · Phase 3, Interventional, and Health services research
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.
1,439 studies on the registry are indexed under Opioid-Related Disorders; 291 are open to participants now.
This study's enrollment of 100 is above the median of 62 across 1,145 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →The University of New South Wales is the lead sponsor of 66 studies on the registry; 6 are open to participants now.
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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:
Exclusion criteria
Participants who meet any of the exclusion criteria are not to be enrolled in this study:
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.
Also known as: Sublocade
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.
Time frame: Retention in dosing schedule at 48 weeks
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.
Time frame: 48 weeks
Changes in opioid withdrawal
Change in opioid withdrawal assessed by clinical opioid withdrawal scale (COWS) and subjective opioid withdrawal scale (SOWS)
Time frame: 48 weeks
Changes in client-reported opioid craving
Change in client-reported opioid craving assessed by opioid craving scale
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 48 weeks
Demographic factors associated with treatment retention
To evaluate demographic factors (gender, age, education) associated with treatment retention, assessed by demographic questionnaire
Time frame: 48 weeks
Client treatment satisfaction score
Client-reported treatment satisfaction assessed by the Treatment Questionnaire for Medication Satisfaction (TQSM)
Time frame: 48 weeks
BUP-XR treatment costs
Costs to services delivering BUP-XR assessed by site-reported expenses and time and motion study
Time frame: 48 weeks
Plan to share: No
Started May 2019 (actual). Primary completion is estimated for Nov 2020, 17 months after the start.
Of 31 phase 3 interventional studies under Opioid-Related Disorders, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 56. This study's planned 17 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Buprenorphine
The University of New South Wales