Opioid Use After Traumatic Injury in Adolescents

Opioid Use Clinical Trial

Official title:

A Prospective Survey of Opioid Use After Traumatic Injury in Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03628846
• Other study ID #: 1706176501
• Status: Completed
• Start date: July 1, 2018
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: April 30, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Behavior
• Opioid Use
• Substance Abuse Disorder
• Substance-Related Disorders
• Traumatic Injury
• Wounds and Injuries

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prospectively determine drivers of sustained opioid use and prescription opioid misuse.		2 years
Secondary	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
Secondary	Assess behavioral, social, and clinical predictors of prescription opioid misuse and nonmedical opioid use by longitudinally surveying injured adolescents.		2 years
Secondary	Qualitatively determine patients' motives for continued opioid therapy, prescription opioid misuse, and nonmedical opioid use by interviewing injured adolescents.		2 years
Secondary	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