Opioid Use After Traumatic Injury in Adolescents | NCT03628846

Studies
Opioid Use After Traumatic Injury in Adolescents

NCT03628846

Sponsor

Indiana University

Status

Completed

Last Update Posted

May 19, 2023Actual

Enrollment

123Actual

Phase

Not provided

Conditions

Opioid Use
Traumatic Injury
Adolescent Behavior
Substance Abuse Disorder

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2018Actual

Primary Completion Date

Mar 31, 2023Actual

Completion Date

Apr 30, 2023Actual

First Submitted Date

Aug 9, 2018

First Submission Date that Met QC Criteria

Aug 9, 2018

First Posted Date

Aug 14, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 18, 2023

Last Update Posted Date

May 19, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Currently, 1 in 8 adolescents continue to receive prescription opioids a year or more after injury. By longitudinally surveying patients, we can identify risk factors and pathways to nonmedical opioid use. Furthermore, by assessing whether pain management and mental health treatment after injury moderates sustained opioid use and prescription opioid misuse, we can create targeted interventions to reduce future nonmedical opioid use in adolescents.

Detailed Description

This is a prospective cohort study that will follow participants for 2 years and administer surveys to adolescents both traumatically injured and uninjured on prescription opioid usage, substance use, utilization of pain management and mental health services, and mental and physical health condition conditions.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

123Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prospectively determine drivers of sustained opioid use and prescription opioid misuse.		2 years

Secondary Outcomes

Measure	Description	Time Frame
Identify patient-reported factors for sustained prescription opioid use, including chronic pain and mental health conditions such as PTSD, depression, anxiety, and sleep disorders.		2 years
Assess behavioral, social, and clinical predictors of prescription opioid misuse and nonmedical opioid use by longitudinally surveying injured adolescents.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient is 12-20 years of age
Adolescent admitted for trauma OR adolescent with no recent trauma
English speaking
Consent can be obtained from a parent or guardian

Exclusion Criteria:

- Patients with severe brain injuries or other injuries that prevent survey participation

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

20 Years

Standard Ages

ChildAdult

Study Population

Traumatically injured patients admitted to either Eskenazi Hospital or Riley Hospital, between the ages of 12 and 20.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Indiana University		Indianapolis	Indiana	46202	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014947	Wounds and Injuries
D000294	Adolescent Behavior
D019966	Substance-Related Disorders

Ancestor Terms

ID	Term
D001519	Behavior
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Traumatically Injured Adolescent
Not Traumatically Injured Adolescent