None listed
Conditions
Brief summary
Opioid overdose is a major public health issue, causing significant morbidity and mortality. Naloxone is a drug for reversal of opioid overdose and is typically administered through intravenous or intramuscular injection. Intranasal administration of naloxone has several advantages over injection, particularly ease of use and removal of the risk of needle stick injury. This study is a randomised controlled trial to test the hypothesis that naloxone administered intranasally will be non-inferior to naloxone administered intramuscularly in achieving an adequate response (no requirement for a rescue dose of intramuscular naloxone). There is limited quality evidence about intranasal naloxone efficacy. Previous trials used volumes greater than the now-recommended optimal delivery volume for intranasal drug administration, of equal to 0.2ml per nostril, or smaller doses than those typically used in the Australian context. Our trial will evaluate the efficacy of a concentrated naloxone spray (2mg/0.1ml) compared to the 800mcg intramuscular standard in reversing the effects of opioid overdose and the production of any naloxone-associated side-effects.
Interventions
Participants will be randomly assigned to receive either an intranasal spray (intervention arm) or an intramuscular injection (control arm). The trial will be conducted over a 24-month period.
Participants in the intervention arm will receive one dose of 2 mg of intranasal naloxone hydrochloride once. Commercially available intranasal spray- Nyxoid, in a pre-filled intranasal delivery device containing 2 mg of Naloxone hydrochloride in 0.1 ml of fluid will be used.
The intranasal delivery devi
Participants will be randomly assigned to receive either an intranasal spray (intervention arm) or an intramuscular injection (control arm). The trial will be conducted over a 24-month period. Participants in the intervention arm will receive one dose of 2 mg of intranasal naloxone hydrochloride once. Commercially available intranasal spray- Nyxoid, in a pre-filled intranasal delivery device containing 2 mg of Naloxone hydrochloride in 0.1 ml of fluid will be used. The intranasal delivery device will be inserted into one nostril and the plunger depressed, delivering the contents as a fine atomised spray.
Sponsors
Burnet Institute
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants will be clients of the Medically Supervised Injecting Room (MSIR) who experience suspected overdose according to MSIR protocols and who have not chosen to opt out of the study. Consistent with current MSIR protocols, only those who do not respond to five minutes of initial breathing support with 100% oxygen or bag-valve-mask (i.e. respiratory rate less than 8 breaths per minute, Glasgow Coma Scale score less than 13, and oxygen saturation less than or equal to 95%) will be eligible for inclusion. To use the MSIR potential participants must: • Indicate that they wish to inject drugs in the facility. • Be aged 18 years or over. • Not have any accompanying children. • Not be pregnant.
Exclusion criteria
The study will follow MSIR exclusion criteria. They are: • Pregnant women - If it is suspected by MSIR staff that a client may be pregnant, they are referred to a local alcohol or other drug program where they undergo a pregnancy test. The results are then returned to MSIR. • Under eighteen years of age - If it is suspected a potential client may be under eighteen years old, formal identification (ID) is requested of the potential client by MSIR staff. If the person is over eighteen, a copy of the ID is kept on file. If the person is under eighteen, they are referred to a local drug and alcohol service. • Anyone who presents as already intoxicated. • Anyone accompanied by a child. • Anyone who has not previously injected drugs. No additional study-specific exclusion criteria will be applied.
Outcome results
None listed