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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03628846
Recruitment Status : Recruiting
First Posted : August 14, 2018
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Teresa Maria Bell, Indiana University

Brief Summary:
The purpose of this study is to prospectively follow a cohort of traumatically injured adolescents to 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 by longitudinally surveying injured adolescents; and 2) Assess clinical, behavioral, and social predictors of prescription opioid misuse and nonmedical opioid use.

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

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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





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 ]

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


Information from the National Library of Medicine

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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


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


Contacts
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Contact: Jodi Raymond, MPH, CSTR, CAISS 3179445434 jraymond3@iuhealth.org
Contact: Ashley Vetor, MPH, CCRP 3172747493 abozell@iu.edu

Locations
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United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Teresa M Bell, PhD    317-274-7435    terebell@iupui.edu   
Sponsors and Collaborators
Indiana University

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Responsible Party: Teresa Maria Bell, Assistant Professor of Surgery, Indiana University
ClinicalTrials.gov Identifier: NCT03628846     History of Changes
Other Study ID Numbers: 1706176501
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019

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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