The intranasal administration of naloxone confers many advantages over other routes of administration, particularly in relation to take home naloxone (THN) as it avoids complications with the use of needles such as the risks of needle-stick injury and requires less training. As a consequence, many THN programs distribute naloxone for intranasal administration despite this route of administration being sub-optimal.
However, new pharmacokinetic data published by a member of our team suggests that comparable efficacy may be able to be achieved with larger intranasal doses than used in our trials. We will test this hypothesis in a non-inferiority controlled trial conducted in clinical practice at the Sydney Medically Supervised Injecting Centre (MSIC).
Our primary aim is to test whether 2mg naloxone administered intranasally is not inferior to 400mcg administered intramuscularly. Our primary outcome will be the requirement for a rescue dose of naloxone 10 minutes after naloxone administration. We will also explore two secondary analyses:
- Time to respiration >=10 breaths per minute, and
- Time to Glasgow Coma Score >=13
We will also follow up participants to learn of their experience in the two hours after overdose. This follow-up will underpin two secondary aims through which we will determine the nature and extent of any post-overdose:
- Precipitated withdrawal participants might have experienced, and
- Use of opioids and/or other drugs (including alcohol)