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Clinical Trial Details — Status: Withdrawn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
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Emergencies
• Opioid Dependence
• Opioid Intoxication
• Opioid-Related Disorders
• Substance Use Disorders
• Substance-Related Disorders

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