Back to resultsNaloxone to TReatment Entry in the Emergency Setting (N-TREE)
Primary Purpose
Opioid Dependence, Opioid Intoxication, Substance Use Disorders
Status
Withdrawn
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Active treatment referral of opioid overdose survivors to long-term treatment
Control
Sponsored by
About this trial
This is an interventional treatment trial for Opioid Dependence
Eligibility Criteria
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
Sites / Locations
- Malmö Addiction Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Control
Arm Description
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.
Information-only. Ambulance staff hand over written information to the individual about how to seek treatment for the substance use disorder.
Outcomes
Primary Outcome Measures
Treatment entry
Entry into formal assessment for evidence-based treatment of opioid use disorder
Secondary Outcome Measures
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
Treatment outcome (urinalysis)
Drug-free status in treatment, as documented from hospital records of drug-free urines
Treatment outcome (hair analysis)
Drug-free status in treatment, as documented by hair analysis
Treatment outcome (self-report)
Drug-free status in treatment, described through self-report (AUDIT, DUDIT)
Treatment outcome (quality of life)
Self-report, EQ-5D (European Quality of life - 5 Dimensions) and visual analogue scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03368794
Brief Title
Naloxone to TReatment Entry in the Emergency Setting
Acronym
N-TREE
Official Title
Naloxone to TReatment Entry in the Emergency Setting
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Practical difficulties in starting active recruitment.
Study Start Date
September 15, 2017 (Actual)
Primary Completion Date
March 12, 2021 (Actual)
Study Completion Date
March 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anders C Håkansson
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Dependence, Opioid Intoxication, Substance Use Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Information-only. Ambulance staff hand over written information to the individual about how to seek treatment for the substance use disorder.
Intervention Type
Behavioral
Intervention Name(s)
Active treatment referral of opioid overdose survivors to long-term treatment
Intervention Description
Telephone alert and outreach for inclusion, assessment and intake into long-term evidence-based treatment of the substance use disorder.
Intervention Type
Behavioral
Intervention Name(s)
Control
Other Intervention Name(s)
Information-only
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment entry
Description
Entry into formal assessment for evidence-based treatment of opioid use disorder
Time Frame
Two weeks
Secondary Outcome Measure Information:
Title
Treatment retention
Description
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
Time Frame
3, 6, 12, 24 and 36 months
Title
Treatment outcome (urinalysis)
Description
Drug-free status in treatment, as documented from hospital records of drug-free urines
Time Frame
3, 6, 12, 24 and 36 months
Title
Treatment outcome (hair analysis)
Description
Drug-free status in treatment, as documented by hair analysis
Time Frame
3 months
Title
Treatment outcome (self-report)
Description
Drug-free status in treatment, described through self-report (AUDIT, DUDIT)
Time Frame
3, 6, 12, 24 and 36 months
Title
Treatment outcome (quality of life)
Description
Self-report, EQ-5D (European Quality of life - 5 Dimensions) and visual analogue scale
Time Frame
3, 6, 12, 24 and 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Håkansson, MD, PhD
Organizational Affiliation
Lund University. Region Skåne.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Malmö Addiction Center
City
Malmö
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Naloxone to TReatment Entry in the Emergency Setting
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