Synopsis
This is a single-site, uncontrolled, open-label feasibility study. Adults who are treatment-resistant injecting opioid dependent will be offered up to 24 months of twice daily supervised parenteral hydromorphone plus oral long-acting opioid treatment followed by 3 months oral methadone treatment. Dosage range 50-400 mg/day (maximum 200 mg/dose). This is followed by transition to Opioid Agonist Therapy (OAT) as per standard of care. The study will be conducted over 182 weeks, 104 of which are study treatment duration. The target sample size is 30 participants, with a minimum of 20 participants.
The study will investigate the feasibility, safety, and cost of time-limited injectable hydromorphone treatment. Feasibility will be assessed by recruitment, stabilisation on treatment, and (within 24 months) the outcome of transfer of people with treatment-resistant opioid use disorder to standard OAT.
The combination of accessible, sustainable treatment means this approach to Supervised Injectable Opioid Treatment (SIOT) has the potential to enhance the effectiveness of OAT as a public health measure.
Investigators
A/Prof James Bell
UNSW / Social Policy Research Centre
Prof Alison Ritter AO
UNSW / Drug Policy Modelling Program
Prof Carla Treloar
UNSW / Centre for Social Research in Health
Prof Nadine Ezard
SVHS/UNSW/National Centre for Clinical Research on Emerging Drugs
Dr Darren Roberts
SVHA / UNSW
Dr Krista Siefried
UNSW/National Centre for Clinical Research on Emerging Drugs
Dr Vendula Belackova
Medically Supervised Injecting Centre
Prof Adrian Dunlop
Hunter New England LHD/Drug and Alcohol Clinical Services
Dr Marianne Jauncey
Medically Supervised Injecting Centre
Prof Nicholas Lintzeris
South East Sydney LHD/Drug and Alcohol Services
Dr Eugenia Oviedo-Joekes
University of British Columbia
Dr Marian Shanahan
UNSW/NDARC
Prof John Strang
Kings College London
Prof Wim van den Brink
University of Amsterdam