None listed
Conditions
Brief summary
The aim of this study is to determine whether naloxone, an opioid reversal agent, is as effective for the treatment of acute opioid overdose when administered via the intranasal (IN) route compared with the intramuscular route. The term 'opioid' refers to a class of drugs that includes heroin, and the prescription medications oxycontin and morphine. Injection of naloxone into a muscle is currently the standard method of emergency treatment for an opioid overdose on site at the Sydney Medically Supervised Injecting Centre. However, Naloxone can be administered as an intranasal (IN) spray using a 'mucosal atomisation device’. Evidence suggests that IN naloxone may be an effective and practical alternative. The significant benefits of IN administration include removing the risk of needlestick injury (and thus any blood borne virus transmission risk) to treating personnel. This is particularly relevant to ambulance officers and paramedics, as well as other emergency health care workers, such as in the hospital emergency department setting. Additionally, given the ease of administration and reduced issues regarding disposal of used needles, the availability of IN naloxone may potentially be extended. This may include non health care workers who regularly deal with opioid overdose in community settings, and drug users’ peers, who are likely to be present in the event of an overdose. The Sydney Medically Supervised Injecting Centre (MSIC) provides the ideal setting for this study.
Interventions
800mcg/mL active naloxone intranasally and intramuscular placebo, or 800mcg/mL active naloxone intramuscularly and intranasal placebo. This will be a 'once off' intervention. If a second dose is required, this will be by the standard procedure of 800mcg/2mL intramuscularly.
Contents of the vial for IN administration will be drawn into one syringe. Staff will attach the syringe to a MAD, and administer 0.5mL (400mcg) into each nostril, depressing the syringe rapidly to achieve adequate atomi
800mcg/mL active naloxone intranasally and intramuscular placebo, or 800mcg/mL active naloxone intramuscularly and intranasal placebo. This will be a 'once off' intervention. If a second dose is required, this will be by the standard procedure of 800mcg/2mL intramuscularly. Contents of the vial for IN administration will be drawn into one syringe. Staff will attach the syringe to a MAD, and administer 0.5mL (400mcg) into each nostril, depressing the syringe rapidly to achieve adequate atomisation. In this way, each study participants will receive 0.5mL of fluid in each nostril. Supportive care/oxygenation will be administered simultaneously, in accordance with existing MSIC clinical protocols Administration of the IM injection will be by standard practice of drawing the full 1ml into a single 5ml syringe and administering to the deltoid muscle via a 21g needle.
Sponsors
Sydney Medically Supervised Injecting Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
All clients with symptoms/signs of an opioid overdose requiring Naloxone administration will be eligible for entry. This is based on existing and approved MSIC protocols and clinical criteria for overdose (reduced level of consciousness as measured by the Glasgow Coma Score, pinpoint pupils, respiratory depression and/or reduced oxygen saturations as measured by pulse oximetry).
Exclusion criteria
Less than 18 years of age Pregnant or suspected of being pregnant
Outcome results
None listed