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Opioid Use After Traumatic Injury in Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03628846
Recruitment Status : Active, not recruiting
First Posted : August 14, 2018
Last Update Posted : August 25, 2021
Sponsor:
Information provided by (Responsible Party):
Olena Mazurenko, Indiana University

Study Description
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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.

Condition or disease
Opioid Use Traumatic Injury Adolescent Behavior Substance Abuse Disorder

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 Design
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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Survey of Opioid Use After Traumatic Injury in Adolescents
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Traumatically Injured Adolescent
Not Traumatically Injured Adolescent


Outcome Measures
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Primary Outcome Measures :
  1. Prospectively determine drivers of sustained opioid use and prescription opioid misuse. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Identify patient-reported factors for sustained prescription opioid use, including chronic pain and mental health conditions such as PTSD, depression, anxiety, and sleep disorders. [ Time Frame: 2 years ]
  2. Assess behavioral, social, and clinical predictors of prescription opioid misuse and nonmedical opioid use by longitudinally surveying injured adolescents. [ Time Frame: 2 years ]
  3. Qualitatively determine patients' motives for continued opioid therapy, prescription opioid misuse, and nonmedical opioid use by interviewing injured adolescents. [ Time Frame: 2 years ]
  4. 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. [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
Saliva will be collected at baseline only for the purpose of analyzing genetic data on each participant.

Eligibility Criteria
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Ages Eligible for Study:   12 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03628846


Locations
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United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
More Information
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Responsible Party: Olena Mazurenko, Associate Professor of Health Policy, Indiana University
ClinicalTrials.gov Identifier: NCT03628846    
Other Study ID Numbers: 1706176501
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: August 25, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Substance-Related Disorders
Wounds and Injuries
Chemically-Induced Disorders
Mental Disorders