Opioid Overdose Clinical Trial
Official title:
Incidence and Predictors of Opioid Overdose and Death Among Users of Opioid Analgesics as Measured by Diagnoses and Death Records - a Retrospective Database Study
Verified date | July 2022 |
Source | Member Companies of the Opioid PMR Consortium |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Retrospective study to assess incidence and predictors of opioid abuse overdose and death associated with opioid overdose among patients prescribed opioid products in long-term use.
Status | Completed |
Enrollment | 808455 |
Est. completion date | June 30, 2021 |
Est. primary completion date | June 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 79 Years |
Eligibility | Inclusion Criteria: - In the primary analysis, persons known to have had at least six months of no opioid dispensing who subsequently receive at least 70 days of Schedule II opioid dispensed within a 90-day period and who have not previously experienced an opioid overdose. - In a secondary analysis, persons who have been long-term users of IR/SA opioids and who switch to a different Schedule II IR/SA opioid product or to an ER/LA opioid - In another secondary analysis, persons with at least six months of presence in the health insurance data who have not received opioids in the preceding 30 days, and have not previously experienced an opioid overdose Exclusion Criteria: • Experience of opioid overdose in the six months preceding inclusion |
Country | Name | City | State |
---|---|---|---|
United States | Optum | Boston | Massachusetts |
United States | Vanderbilt University | Nashville | Tennessee |
United States | Kaiser Permanente Northwest | Portland | Oregon |
United States | HealthCore Inc | Wilmington | Delaware |
Lead Sponsor | Collaborator |
---|---|
Member Companies of the Opioid PMR Consortium | HealthCore, Inc., Kaiser Permanente, Optum, Inc., Vanderbilt University, World Health Information Science Consultants, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Opioid overdose - fatal and nonfatal | Opioid overdose as identified in insurance claims, electronic medical records and National Death Index records. | Retrospective review over period from October 1, 2006 to December 31, 2017 |
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