Depot Buprenorphine Trial
Opioid dependence is a serious, chronic, relapsing condition that can affect all aspects of a person’s life. Medication-assisted treatment is widely recognised as the most effective treatment for opioid dependence. In Australia, three medications are approved for medication-assisted treatment for opioid dependence: methadone, sublingual buprenorphine and sublingual buprenorphine/naloxone.
The DEBUT study aimed to investigate a new medication to treat opioid dependence called CAM2038 (Buvidal). CAM2038 (Buvidal) contains the active ingredient buprenorphine and is administered as a subcutaneous injection. The DEBUT studied aimed to determine participants treatment satisfaction with CAM2038 (Buvidal) weekly/monthly injections in comparison to taking daily sublingual buprenorphine to treat opioid dependence.
The study was a prospective, randomised, open-label, active-controlled, multi-centre trial comparing the treatment effects of CAM2038 (Buvidal) with buprenorphine standard of care in adult outpatients with opioid dependence. Participants were randomised to either treatment with the study drug CAM2038 (Buvidal) or to treatment as usual (ie. Buprenorphine/Naloxone as per local standard practice). The participants were assessed over a treatment duration of 24 weeks in relation to treatment satisfaction, quality of life, as well as general wellbeing. The DEBUT study recruited 120 participants across six specialist services in NSW, VIC and SA. The study completed recruitment at Turning Point in late 2019.
A qualitative study was also conducted to explore patients’ views about: (i) being prescribed Buvidal and care; (ii) the social effects that Buvidal had on their lives; and, (iii) how future care and patient information could be improved. This involved conducting in-depth, semi-structured interviews with participants in Australia (n=30) who were in the DEBUT study or who had been prescribed Buvidal at a study site.
CAM2038 (Buvidal) was approved by the Therapeutic Goods Administration in 2019 and is now available for prescribing in for opioid dependence in Australia.
The trial is registered by the Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12618001759280.
Turning Point team
Professor Dan Lubman, Dr Shalini Arunogiri, Dr Vicky Phan, Dr Noel Plumley, Dr Keri Alexander, Professor Mathew Frei, Dr Behrooz Maylie, Ms Michelle Sharkey, Ms Temika Mu, Ms Davinia Rizzo, Dr Michael Savic, Dr Anthony Barnett, and Mr Ramez Bathish.
Professor Nicholas Lintzeris (The Langton Centre - South East Sydney Local Health District, NSW), Professor Paul Haber (The Royal Prince Alfred Hospital NSW), Professor Adrian Dunlop (Hunter New England Local Health District Drug and Alcohol Clinical Services NSW), Dr Robert Graham (Western Sydney Local Health District, NSW), and Associate Professor Mike McDonough (Drug and Alcohol Services SA).