Opioid Use After Traumatic Injury in Adolescents

A Prospective Survey of Opioid Use After Traumatic Injury in Adolescents

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.

Study Overview

• Status: Completed
• Conditions: Opioid Use; Adolescent Behavior; Substance Abuse Disorder; Traumatic Injury

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.

• Study Type: Observational
• Enrollment (Actual): 123

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Traumatically Injured Adolescent
Not Traumatically Injured Adolescent

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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.	2 years
Qualitatively determine patients' motives for continued opioid therapy, prescription opioid misuse, and nonmedical opioid use by interviewing injured adolescents.	2 years
Analyze genetic information, obtained via saliva sample and the company 23andMe, from each participant to determine if some people are more likely to use more pain medication than others or respond better to certain pain medications.	2 years

Collaborators and Investigators

• Sponsor: Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: August 9, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 18, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Wounds and Injuries
• Other Study ID Numbers: 1706176501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No