Naloxone to TReatment Entry in the Emergency Setting

NCT03368794 | Withdrawn

• 1 other identifier: N-TREE
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Dependence; Opioid Intoxication; Substance Use Disorders

Outcome Measures

Primary Outcomes (1)

• Treatment entry

  Entry into formal assessment for evidence-based treatment of opioid use disorder

  Two weeks

Secondary Outcomes (5)

• Treatment retention

  3, 6, 12, 24 and 36 months

• Treatment outcome (urinalysis)

  3, 6, 12, 24 and 36 months

• Treatment outcome (hair analysis)

  3 months

• Treatment outcome (self-report)

  3, 6, 12, 24 and 36 months

• Treatment outcome (quality of life)

  3, 6, 12, 24 and 36 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Behavioral: Control

Interventions

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

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

Intervention

Control 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.

Also known as: Information-only

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• survivor of opioid overdose requiring antidote naloxone administration by ambulance staff, and provision of written informed consent

You may not qualify if:

• patients unable to understand study information and to provide informed consent

Sponsors & Collaborators

• Anders C Håkansson: lead

Study Sites (1)

Malmö Addiction Center

Malmo, Sweden

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Anders Håkansson, MD, PhD

  Lund University. Region Skåne.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: December 11, 2017
• Study Start: September 15, 2017
• Primary Completion: March 12, 2021
• Study Completion: March 12, 2021
• Last Updated: March 16, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)