Opioid Use Clinical Trial
Official title:
A Prospective Survey of Opioid Use After Traumatic Injury in Adolescents
NCT number | NCT03628846 |
Other study ID # | 1706176501 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2018 |
Est. completion date | April 30, 2023 |
Verified date | May 2023 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Indiana University | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University |
United States,
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 |
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