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Clinical Trials/NCT03368794
NCT03368794
Withdrawn
Not Applicable

Naloxone to TReatment Entry in the Emergency Setting

Anders C Håkansson1 site in 1 countrySeptember 15, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Opioid Dependence
Sponsor
Anders C Håkansson
Locations
1
Primary Endpoint
Treatment entry
Status
Withdrawn
Last Updated
5 years ago

Overview

Brief Summary

The study tests a structured referral process for opioid overdose survivors, from pre-hospital emergency care to long-term treatment of the individual's substance use-related disorder.

Detailed Description

Randomized controlled trial. Subjects are included if they are being treated by an ambulance in the Malmö uptake are for an opioid overdose requiring naloxone antidote administration, and if they sign informed written consent to the study. Subjects are randomized by ambulance staff to either an active intervention, or a control condition: Intervention: A telephone alert signal is sent from ambulance staff after successful naloxone reversal of an opioid overdose, leading to an active outreach effort from the staff of the addiction research facility, where staff locate the individual and offer her/him formal inclusion in the study. Control: No telephone alert signal is sent, and the active outreach procedure is not carried out. Ambulance staff hand over written information to the individual about how she/he can apply actively for treatment. Primary outcome is entry into formal assessment and treatment of the substance use disorder.

Registry
clinicaltrials.gov
Start Date
September 15, 2017
End Date
March 12, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Anders C Håkansson
Responsible Party
Sponsor Investigator
Principal Investigator

Anders C Håkansson

MD, PhD

Region Skane

Eligibility Criteria

Inclusion Criteria

  • survivor of opioid overdose requiring antidote naloxone administration by ambulance staff, and provision of written informed consent

Exclusion Criteria

  • patients unable to understand study information and to provide informed consent

Outcomes

Primary Outcomes

Treatment entry

Time Frame: Two weeks

Entry into formal assessment for evidence-based treatment of opioid use disorder

Secondary Outcomes

  • Treatment outcome (quality of life)(3, 6, 12, 24 and 36 months)
  • Treatment outcome (self-report)(3, 6, 12, 24 and 36 months)
  • Treatment outcome (urinalysis)(3, 6, 12, 24 and 36 months)
  • Treatment retention(3, 6, 12, 24 and 36 months)
  • Treatment outcome (hair analysis)(3 months)

Study Sites (1)

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