CompletedPhase 2ACTRN12611000852954

Randomised, double-blinded clinical trial comparing intranasal and intramuscular naloxone for suspected opioid overdose

Randomised, double-blinded clinical trial comparing intranasal and intramuscular naloxone for reversal of suspected opioid overdose in clients of the Sydney Medically Supervised Injecting Centre


Sponsor

Sydney Medically Supervised Injecting Centre

Enrollment

200 participants

Start Date

Jan 31, 2012

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This trial compares intranasal (nose spray) versus intramuscular (injection) naloxone for reversing suspected opioid overdoses. It enrolls adults aged 18+ who present with signs of opioid overdose including reduced consciousness, pinpoint pupils, and breathing difficulties. Pregnant individuals are excluded.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 req

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.


Locations(1)

NSW, Australia

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ACTRN12611000852954