The majority of buprenorphine-naloxone (Suboxone®) dosing in Australia involves supervised dosing of sublingual tablets in order to enhance medication adherence and to minimise aberrant behaviours such as diversion and/or injecting. Supervision of buprenorphine-naloxone sublingual tablets is difficult in clinic and community pharmacy settings due to the time required (routinely between 3 and 10 minutes), increasing the cost of treatment delivery, patient inconvenience and confidentiality concerns. The introduction of buprenorphine-naloxone sublingual film may reduce the time required for supervised dosing thereby reducing the inconvenience and cost of treatment and related aberrant drug behaviours. Buprenorphine-naloxone sublingual film may also help reduce diversion by providing a dosage form that is difficult for the patient to remove from the sublingual mucosa once administered. This will provide assurance to the caregiver that the dose has actually been taken appropriately. However there is limited experience in the use of buprenorphine-naloxone sublingual film in routine clinical settings. Specifically, research is required that examines whether the film is acceptable to patients and clinicians without any diminution of clinical efficacy and safety.
A/Professor Nicholas Lintzeris (The Langton Centre and Central Clinical School, University of Sydney)
Associate Professor Robert Ali (Discipline of Pharmacology, The University of Adelaide)
Professor Paul Haber (Central Clinical School, University of Sydney)
Dr Adrian Dunlop (Drug and Alcohol Clinical Services, Hunter New England Area Health Service and School of Medicine and Public Health, University of Newcastle)
Stefanie Leung (The Langton Centre)
To assess patient and clinician acceptability of buprenorphine-naloxone sublingual film in patients transferring from buprenorphine-naloxone sublingual tablets. Primary objectives were:
- To assess patient and clinician preferences and ratings of ease of use
- To ascertain dose equivalence between film and tablet
- To monitor and record adverse events
Secondary objectives were:
- To assess impact of changes upon dispensing time and related cost of service delivery
- To assess ease by which the film can be removed following dosing
- To assess any impact upon clinical outcomes such as drug use, psycho-social health and functioning.
The trial recruited 92 opioid-dependent patients engaged in outpatient buprenorphine-naloxone treatment. The study was a double-blind, double-dummy, randomised parallel group design conducted in three phases over a 31-day period: (1) a baseline phase of supervised buprenorphine-naloxone tablet treatment (7 days) followed by randomly allocated treatment with either film or tablets in two stages: (2) a double-blind treatment phase (10 days); followed by (3) an open-label phase (14 days), using a 1:1 random allocation into either film or tablet groups. The study was conducted as a multisite trial across 5 sites.
There were no significant differences between buprenorphine-naloxone tablets and film with regard to subjective dose effects, trough plasma buprenorphine or norbuprenorphine levels, adverse events and treatment outcomes. Buprenorphine-naloxone film took significantly less time to dissolve than tablets.
Papers are currently being prepared.
The study demonstrated dose equivalence and comparable clinical outcomes between the buprenorphine-naloxone film and tablet preparations, while showing improved dispensing times and patient ratings of satisfaction with the film. These findings have important implications for OST policy and provision in Australia.