Intranasal naloxone for the reversal of opioid overdose

INTERVENTION: 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. CONDITION: Mental Health ‐ Addiction Opioid overdose; ; Opioid overdose Public Health ‐ Health service research PRIMARY OUTCOME: Participant response to naloxone, defined as response without the requirement for a rescue dose of naloxone 10 minutes after administration of naloxone[Medical record assessing whether the rescue dose was given 10 mins post naloxone administration 10 mins post naloxone administration] 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. SECONDARY OUTCOME: Drug residues detected in drug paraphernalia (typically needles/syringes but may also include mixing spoons) used at the overdose event. ; Drugs screened for include opioids (e.g. morphine), stimulants (e.g. methamphetamine), benzodiazepines (e.g. alprazolam), and other drugs identified through ongoing surveillance.[Ultra‐high‐performance liquid chromatography–mass spectrometry (UHPLC‐MS) analysis of discarded drug paraphernalia to identify and quantify drug residues. Once weekly throughout the 24‐month study period.] General wellbeing[The EQ‐5D, a widely accepted measure of health‐related quality of life, will be used. 24 hours (recorded within 1‐7 days) post administration of naloxone] Opioid withdrawal[Opioid withdrawal symptoms will be assessed using the Subjective Opioid Withdrawal Scale (SOWS) and the Objective Opioid Withdrawal Scale (OOWS), which are widely accepted measures of opioid withdrawal. 15 minutes, 30 minutes and 24 hours (recorded within 1‐7 days) post administration of naloxone] Post‐rescuscitaion use of alcohol or other drugs (composite outcome)[Drug or alcohol use in the 24 hours following overdose will be assessed using the standard questionnaire previously used in the MIX/SuperMI Xstudy (Horyniak et al., 2013). 24 hours (recorded within 1‐7 days) post administration of naloxone] Time from study drug administration to adequate oxygen saturation (SpO2) of greater than or equal to 95% ; ; [Medical record ; Continuously assessed from study drug administration until the participant achieves an oxygen saturation (SpO2) of greater than or equal to 95%] Time from study drug administration to adequate respiration of greater than or equal to 8 breaths per minute[Medical records Continuously assessed from study drug administration until adequate respiration of greater than or equal to 8 breaths per minute is achieved.] Time from study drug administration to return to alertness defined as achieving “Alert” on the AVPU (Alert, Verbal, Pain, Unresponsive) scale.[Medical record Continuously assessed from study drug administration until the participant achieves an AVPU score of Alert.]