Naloxone to TReatment Entry in the Emergency Setting

Not Applicable

Withdrawn

• Conditions: Opioid Intoxication; Substance Use Disorders; Opioid Dependence
• Interventions: Behavioral: Control; Behavioral: Active treatment referral of opioid overdose survivors to long-term treatment

• Registration Number: NCT03368794
• Lead Sponsor: Anders C Håkansson

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.

Study Timeline

• Study First Submitted: 2017-07-25
• Study Start: 2017-09-15
• Study First Submitted QC: 2017-12-08
• Study First Posted: 2017-12-11
• Status Verified: 2021-03
• Primary Completion: 2021-03-12
• Study Completion: 2021-03-12
• Last Update Submitted: 2021-03-12
• Last Update Posted: 2021-03-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Information-only. Ambulance staff hand over written information to the individual about how to seek treatment for the substance use disorder.
Intervention	Active treatment referral of opioid overdose survivors to long-term treatment	Telephone alert signal from ambulance staff to out-patient substance use disorder treatment facility, for active outreach aiming to locate and include the patient in long-term evidence-based treatment for the substance use disorder.

Primary Outcome Measures

Name	Time	Method
Treatment entry	Two weeks	Entry into formal assessment for evidence-based treatment of opioid use disorder

Secondary Outcome Measures

Name	Time	Method
Treatment outcome (quality of life)	3, 6, 12, 24 and 36 months	Self-report, EQ-5D (European Quality of life - 5 Dimensions) and visual analogue scale
Treatment outcome (self-report)	3, 6, 12, 24 and 36 months	Drug-free status in treatment, described through self-report (AUDIT, DUDIT)
Treatment outcome (urinalysis)	3, 6, 12, 24 and 36 months	Drug-free status in treatment, as documented from hospital records of drug-free urines
Treatment retention	3, 6, 12, 24 and 36 months	Retention in opioid maintenance treatment or other relevant evidence-based treatment for the substance-related condition, as measured in treatment records, and including the analysis of predictors of retention
Treatment outcome (hair analysis)	3 months	Drug-free status in treatment, as documented by hair analysis

Trial Locations

Locations (1)

Malmö Addiction Center; 🇸🇪 Malmö, Sweden