Naloxone to TReatment Entry in the Emergency Setting

Study Overview
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Brief Summary
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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
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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.

Official Title
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Naloxone to TReatment Entry in the Emergency Setting

Conditions
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Opioid Dependence, Opioid Intoxication, Substance Use Disorders

Intervention / Treatment
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* Behavioral: Active treatment referral of opioid overdose survivors to long-term treatment
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Behavioral: Active treatment referral of opioid overdose survivors to long-term treatment<br>* Telephone alert and outreach for inclusion, assessment and intake into long-term evidence-based treatment of the substance use disorder.<br>|
| Active Comparator: Control<br>Information-only. Ambulance staff hand over written information to the individual about how to seek treatment for the substance use disorder. | Behavioral: Control<br>* Written information from ambulance staff to the patient about how to seek treatment. Patient is able to contact the research treatment facility through a specific phone number, making it possible to study treatment entry in the information-only control condition.<br>* Other names: Information-only;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment entry | Entry into formal assessment for evidence-based treatment of opioid use disorder | Two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment retention | 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 | 3, 6, 12, 24 and 36 months | 
| Treatment outcome (urinalysis) | Drug-free status in treatment, as documented from hospital records of drug-free urines | 3, 6, 12, 24 and 36 months | 
| Treatment outcome (hair analysis) | Drug-free status in treatment, as documented by hair analysis | 3 months | 
| Treatment outcome (self-report) | Drug-free status in treatment, described through self-report (AUDIT, DUDIT) | 3, 6, 12, 24 and 36 months | 
| Treatment outcome (quality of life) | Self-report, EQ-5D (European Quality of life - 5 Dimensions) and visual analogue scale | 3, 6, 12, 24 and 36 months |