An Open-Label Pilot Study of Slow-Release Oral Morphine for Opioid Dependence

Investigators: Professor Suzanne Nielsen, Professor Sarah Larney, Dr Thileepan Naren,

Opioid agonist treatment (OAT) is the gold standard for managing opioid dependence in Australia, yet current pharmacotherapy options (methadone and buprenorphine) do not meet the needs of all individuals. Patients who experience suboptimal outcomes or discontinue treatment remain exposed to significant health risks without receiving the full benefits of OAT.

Slow-release oral morphine (SROM) is an established alternative OAT internationally, with evidence demonstrating comparable retention to methadone and potential advantages in reducing cravings, improving mental health outcomes, and offering better tolerability and treatment satisfaction. While international real-world data indicates that SROM has a safety profile similar to methadone, there is currently limited Australian experience with SROM, particularly within community pharmacy-based care delivery models.

The Slow-Release Oral Morphine Pilot (SROMP) study is an open-label, single-arm interventional study designed to build local implementation experience in real-world clinical settings while generating feasibility, safety, and preliminary outcome data. Prior to trial initiation, qualitative interviews will be conducted with consumers and clinicians to identify key barriers and facilitators to SROM implementation.

The primary objective of this study is to assess the feasibility and acceptability of prescribing and dispensing SROM within community pharmacies.

The secondary objectives are to:

  • Evaluate the safety and tolerability of SROM under routine clinical conditions.
  • Generate preliminary estimates of clinical retention, non-prescribed opioid use, craving reductions, and dosing requirements to support future scale-up.
  • Document implementation processes, barriers, and facilitators across prescriber and pharmacy settings to assist the translation of international guidelines to Australian healthcare conditions.

Findings from this pilot will inform the design, sample size, and implementation protocol for a planned fully powered implementation-efficacy trial.

Funder: National Health and Medical Research Council (NHMRC) Investigator Grant (#2025894)