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Standard vs reduced dose naloxone for the reversal of opiate overdose. Does dose modification increase the likelihood of reaching hospital and entering a substance misuse programme? - Standard vs reduced dose naloxone

Standard vs reduced dose naloxone for the reversal of opiate overdose. Does dose modification increase the likelihood of reaching hospital and entering a substance misuse programme? - Standard vs reduced dose naloxone

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-001384-30-GB
Enrollment
190
Registered
2006-06-11
Start date
2006-08-01
Completion date
Unknown
Last updated
2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Accidental, recreational heroin (and other opiate) overdose.

Interventions

Product Name: Naloxone hydrochloride Pharmaceutical Form: Injection* INN or Proposed INN: Naloxone hydrochloride CAS Number: 465-65-6 Cu

Sponsors

Brighton and Sussex Universities Hospitals Trust Research and Development Directorate
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria: • Known or suspected opiate OD AND • Age >18 AND • Weight >40 kg (estimated) AND • Respiratory rate =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Main Objective: 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; Secondary Objective: 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 ;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

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026