N-TREE: Naloxone to TReatment Entry in the Emergency Setting
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention 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
Telephone alert and outreach for inclusion, assessment and intake into long-term evidence-based treatment of the substance use disorder.
|
| Active Comparator: Control Information-only. Ambulance staff hand over written information to the individual about how to seek treatment for the substance use disorder. |
Behavioral: Control
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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Treatment entry [Two weeks]
Entry into formal assessment for evidence-based treatment of opioid use disorder
Secondary Outcome Measures
- 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 (urinalysis) [3, 6, 12, 24 and 36 months]
Drug-free status in treatment, as documented from hospital records of drug-free urines
- Treatment outcome (hair analysis) [3 months]
Drug-free status in treatment, as documented by hair analysis
- Treatment outcome (self-report) [3, 6, 12, 24 and 36 months]
Drug-free status in treatment, described through self-report (AUDIT, DUDIT)
- 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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Malmö Addiction Center | Malmö | Sweden |
Sponsors and Collaborators
- Anders C Håkansson
Investigators
- Principal Investigator: Anders Håkansson, MD, PhD, Lund University. Region Skåne.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- N-TREE