Opioid DependenceN-TREENCT03368794
Naloxone to TReatment Entry in the Emergency Setting
A study testing Active treatment referral of opioid overdose survivors to long-term treatment in people with Opioid Dependence and Opioid Intoxication, run by Anders C Håkansson at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Dependence, Opioid Intoxication, Substance Use Disorders
- What is being tested?
- Active treatment referral of opioid overdose survivors to long-term treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- 15 Sep 2017to 12 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- survivor of opioid overdose requiring antidote naloxone administration by ambulance staff, and provision of written informed consent
Who cannot join
- patients unable to understand study information and to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Active treatment referral of opioid overdose survivors to long-term treatment, Control
- Medical subject headings
- Opioid-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active treatment referral of opioid overdose survivors to long-term treatmentBehavioural
Telephone alert and outreach for inclusion, assessment and intake into long-term evidence-based treatment of the substance use disorder.
ControlBehavioural
Also called Information-only
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment entry
Entry into formal assessment for evidence-based treatment of opioid use disorder
Measured: Two weeks
Secondary outcomes (5)
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
Measured: 3, 6, 12, 24 and 36 months
Treatment outcome (urinalysis)
Drug-free status in treatment, as documented from hospital records of drug-free urines
Measured: 3, 6, 12, 24 and 36 months
Treatment outcome (hair analysis)
Drug-free status in treatment, as documented by hair analysis
Measured: 3 months
Treatment outcome (self-report)
Drug-free status in treatment, described through self-report (AUDIT, DUDIT)
Measured: 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
Measured: 3, 6, 12, 24 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start15 Sep 2017
- Primary completion12 Mar 2021
- Study completion12 Mar 2021
Why it stopped: Practical difficulties in starting active recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anders C Håkansson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anders C Håkansson, Region Skane
- Investigators
- Anders Håkansson, MD, PhD, Principal investigator, Lund University. Region Skåne.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03368794
- Sponsor's protocol ID
- N-TREE
- Acronym
- N-TREE
- Status last verified
- Mar 2021
- First submitted
- 25 Jul 2017
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Naloxone to TReatment Entry in the Emergency Setting
- ClinicalTrials.gov ID
- NCT03368794
- Acronym / sponsor ID
- N-TREE / N-TREE
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Practical difficulties in starting active recruitment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Anders C HåkanssonUniversity, hospital or other
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 12 Mar 2021 (actual)
- Study completion
- 12 Mar 2021 (actual)
- First posted
- 11 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Active treatment referral of opioid overdose survivors to long-term treatmentTelephone 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. |
| Control | Active comparator | Behavioral: ControlInformation-only. Ambulance staff hand over written information to the individual about how to seek treatment for the substance use disorder. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- survivor of opioid overdose requiring antidote naloxone administration by ambulance staff, and provision of written informed consent
Key exclusion criteria (1 listed)
- patients unable to understand study information and to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active treatment referral of opioid overdose survivors to long-term treatmentTelephone alert and outreach for inclusion, assessment and intake into long-term evidence-based treatment of the substance use disorder. | Behavioural | Intervention |
| ControlAlso: Information-onlyWritten 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. | Behavioural | Control |
Primary outcome
Treatment entry
Time frame: Two weeks
Entry into formal assessment for evidence-based treatment of opioid use disorder
5 secondary outcomes
Treatment retention
Time frame: 3, 6, 12, 24 and 36 months
Treatment outcome (urinalysis)
Time frame: 3, 6, 12, 24 and 36 months
Treatment outcome (hair analysis)
Time frame: 3 months
Treatment outcome (self-report)
Time frame: 3, 6, 12, 24 and 36 months
Treatment outcome (quality of life)
Time frame: 3, 6, 12, 24 and 36 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Håkansson, MD, PhD principal investigator
Lund University. Region Skåne.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active treatment referral of opioid overdose survivors to long-term treatment in people with Opioid Dependence and Opioid Intoxication, run by Anders C Håkansson at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment entry (time frame: Two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.