Naloxone to TReatment Entry in the Emergency Setting

NCT ID: NCT03368794

Last Updated: 2021-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-15

Study Completion Date

2021-03-12

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.

Conditions

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Opioid Dependence Opioid Intoxication Substance Use Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Active treatment referral of opioid overdose survivors to long-term treatment

Intervention Type BEHAVIORAL

Telephone alert and outreach for inclusion, assessment and intake into long-term evidence-based treatment of the substance use disorder.

Control

Information-only. Ambulance staff hand over written information to the individual about how to seek treatment for the substance use disorder.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Information-only

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anders C Håkansson

OTHER

Sponsor Role lead

Responsible Party

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Anders C Håkansson

MD, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Anders Håkansson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Lund University. Region Skåne.

Locations

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Malmö Addiction Center

Malmo, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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N-TREE

Identifier Type: -

Identifier Source: org_study_id

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