Naloxone to TReatment Entry in the Emergency Setting (N-TREE)

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.

Study Overview

• Status: Withdrawn
• Conditions: Substance Use Disorders; Opioid Dependence; Opioid Intoxication
• Intervention / Treatment: Behavioral: Active treatment referral of opioid overdose survivors to long-term treatment; Behavioral: Control

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Malmö, Sweden
    • Malmö Addiction Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: Information-only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment entry	Entry into formal assessment for evidence-based treatment of opioid use disorder	Two weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Treatment outcome (urinalysis)	Drug-free status in treatment, as documented from hospital records of drug-free urines	3, 6, 12, 24 and 36 months
Treatment outcome (hair analysis)	Drug-free status in treatment, as documented by hair analysis	3 months
Treatment outcome (self-report)	Drug-free status in treatment, described through self-report (AUDIT, DUDIT)	3, 6, 12, 24 and 36 months
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

Collaborators and Investigators

• Sponsor: Anders C Håkansson
• Investigators: Principal Investigator: Anders Håkansson, MD, PhD, Lund University. Region Skåne.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2017
• Primary Completion (Actual): March 12, 2021
• Study Completion (Actual): March 12, 2021

Study Registration Dates

• First Submitted: July 25, 2017
• First Submitted That Met QC Criteria: December 8, 2017
• First Posted (Actual): December 11, 2017

Study Record Updates

• Last Update Posted (Actual): March 16, 2021
• Last Update Submitted That Met QC Criteria: March 12, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Disease Attributes; Narcotic-Related Disorders; Substance-Related Disorders; Emergencies; Opioid-Related Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: N-TREE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No