NCT03628846

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 9, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

May 19, 2023

Status Verified

May 1, 2023

Enrollment Period

4.8 years

First QC Date

August 9, 2018

Last Update Submit

May 18, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prospectively determine drivers of sustained opioid use and prescription opioid misuse.

    2 years

Secondary Outcomes (4)

  • 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

Study Arms (2)

Traumatically Injured Adolescent

Not Traumatically Injured Adolescent

Eligibility Criteria

Age12 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva will be collected at baseline only for the purpose of analyzing genetic data on each participant.

MeSH Terms

Conditions

Wounds and InjuriesAdolescent BehaviorSubstance-Related Disorders

Condition Hierarchy (Ancestors)

BehaviorChemically-Induced DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Health Policy

Study Record Dates

First Submitted

August 9, 2018

First Posted

August 14, 2018

Study Start

July 1, 2018

Primary Completion

March 31, 2023

Study Completion

April 30, 2023

Last Updated

May 19, 2023

Record last verified: 2023-05

Locations