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NCT03368794 Clinical Trial

Naloxone to TReatment Entry in the Emergency Setting

Substance Use Disorders Clinical Trial

— N-TREE  

Official title:
Naloxone to TReatment Entry in the Emergency Setting

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03368794
Other study ID # N-TREE
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date September 15, 2017
Est. completion date March 12, 2021

Study information
Verified date March 2021
Source Region Skane
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date March 12, 2021
Est. primary completion date March 12, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.
• 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.

Locations
Country Name City State
Sweden Malmö Addiction Center Malmö

Sponsors (1)
Lead Sponsor Collaborator
Anders C Håkansson

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Treatment entry Entry into formal assessment for evidence-based treatment of opioid use disorder Two weeks
Secondary 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
Secondary Treatment outcome (urinalysis) Drug-free status in treatment, as documented from hospital records of drug-free urines 3, 6, 12, 24 and 36 months
Secondary Treatment outcome (hair analysis) Drug-free status in treatment, as documented by hair analysis 3 months
Secondary Treatment outcome (self-report) Drug-free status in treatment, described through self-report (AUDIT, DUDIT) 3, 6, 12, 24 and 36 months
Secondary 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
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