E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Accidental, recreational heroin (and other opiate) overdose. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Too see if titrated dose naloxone improves the likelihood of the opiate overdosed patient of reaching the definitive care setting i.e. the emergency department |
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E.2.2 | Secondary objectives of the trial |
To see if titrated dose naloxone improves the likelihood of successful enrolment in the local substance misuse service and whether there is a longer term reduction in 999 calls for opiate overdose To compare the relative rates of opiate-related side effects (airway compromise, aspiration, respiratory failure, hypotension) in the pre- and post-implementation group To look at the impact that titrated dose naloxone has on the local ambulance service |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Inclusion criteria: • Known or suspected opiate OD AND • Age >18 AND • Weight >40 kg (estimated) AND • Respiratory rate <8 OR airway compromise OR hypoxia (<90%) OR GCS <9
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E.4 | Principal exclusion criteria |
Exclusion criteria: • Tracheal intubation already performed OR • Improving neurological status OR • Active seizure OR • Documented hypoglycaemia OR • Other obvious cause for decreased level of consciousness OR • Known allergy to naloxone
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary end point is follow up at the substance misuse service, the time frame for which depends on the date given for the appointment and starts from the date and time that the participant is enrolled |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Data will be taken before and after the implementation of the titrated naloxone protocol |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Standard dose naloxone (400mcg) |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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This occurs after the last patient enrolled has (or has not) followed up at their substance misuse appointment. This will be several weeks after the last patient is enrolled because of the delay between the initial presentation and the appointment date |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 9 |