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Two world first studies of depot buprenorphine completed

Two world first studies of depot buprenorphine have recently been completed. Both studies are great achievements at the forefront of international research efforts in this field and have salience as part of the response to COVID-19.

The DEBUT Study  
Professor Nicholas Lintzeris, Director, Drug and Alcohol Services, South Eastern Sydney Local Health District, NSW Health, recently led and completed a randomised controlled trial (RCT) of depot buprenorphine versus routine care using sublingual buprenorphine with 120 participants, across six study sites in NSW, Victoria and South Australia. 

This is the first open-label RCT in the world comparing the new depot buprenorphine formulation, and provides the first head to head comparison that allows genuine comparison on patient experience measures and cost effectiveness – which were not able to be examined in earlier blinded RCTs. A qualitative study examining patient experiences has also been completed. 

The study was instrumental in providing clinical experience in the use of these medications, and led to the development of NSW Health clinical guidelines for the use of depot buprenorphine formulations (which have in turn informed guidelines across Australia, the UK and Europe), and training programs for health providers, which have been rolled out across NSW alcohol and other drug services.

The UNLOC-T Study
Prof Lintzeris is also a Chief Investigator on another world first trial examining the use of depot buprenorphine in prison settings, conducted with services in NSW Justice Health, and colleagues at Sydney Local Health District (SLHD), Hunter New England Local Health District (HNELHD), The University of Sydney and The University of Newcastle. This study has led to the widespread uptake of depot buprenorphine treatment in NSW prison settings and is at the forefront of international developments in this field. 

Whilst both studies are in the process of final analysis and submission for publication, they highlight the translational capacity of clinical research to drive changes in clinical research. These studies, along with an open-label single arm study of another depot buprenorphine formulation led by researchers from the National Drug and Alcohol Research Centre (NDARC) at UNSW Sydney, have fast-tracked the uptake of these new treatment approaches – and just in time. 

Depot buprenorphine medications are seen as a significant response to the COVID-19 pandemic, enabling more effective social distancing and isolation of clients as they only have to attend once a month for dosing – as opposed to attending a clinic or pharmacy daily or several times a week. In many services in NSW, depot buprenorphine treatment accounts for 20-30% of all opioid agonist treatment – a remarkable uptake as the medications have been licensed in this country for only six months.    
Professor Nicholas Lintzeris is an Executive Committee Member of the UNSW Medicine Neuroscience, Mental Health and Addiction Theme and Maridulu Budyari Gumal – SPHERE Clinical Academic Group.