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Naloxone to TReatment Entry in the Emergency Setting

Naloxone to TReatment Entry in the Emergency Setting

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03368794
Acronym
N-TREE
Enrollment
0
Registered
2017-12-11
Start date
2017-09-15
Completion date
2021-03-12
Last updated
2021-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Dependence, Opioid Intoxication, Substance Use Disorders

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.

Interventions

BEHAVIORALActive 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.

BEHAVIORALControl

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.

Sponsors

Anders C Håkansson
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Treatment entryTwo weeksEntry into formal assessment for evidence-based treatment of opioid use disorder

Secondary

MeasureTime frameDescription
Treatment outcome (self-report)3, 6, 12, 24 and 36 monthsDrug-free status in treatment, described through self-report (AUDIT, DUDIT)
Treatment outcome (hair analysis)3 monthsDrug-free status in treatment, as documented by hair analysis
Treatment retention3, 6, 12, 24 and 36 monthsRetention 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 monthsDrug-free status in treatment, as documented from hospital records of drug-free urines
Treatment outcome (quality of life)3, 6, 12, 24 and 36 monthsSelf-report, EQ-5D (European Quality of life - 5 Dimensions) and visual analogue scale

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026