Substance Use Disorders Clinical Trial
— N-TREEOfficial title:
Naloxone to TReatment Entry in the Emergency Setting
Verified date | March 2021 |
Source | Region Skane |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Malmö Addiction Center | Malmö |
Lead Sponsor | Collaborator |
---|---|
Anders C Håkansson |
Sweden,
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 |
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