Incidence and Predictors of Opioid Overdose and Death Among Users of Opioid Analgesics as Measured by Diagnoses and Death Records - a Retrospective Database Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 808,455
- Locations
- 4
- Primary Endpoint
- Opioid overdose - fatal and nonfatal
Study Overview
Brief Summary
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.
Detailed Description
The purpose of this study is to quantify risk, and predictors of risks for opioid overdose and for death associated with opioid overdose in persons who are or have been long-term recipients of prescriptions for Schedule II opioids. The study uses coded terms in large heath databases maintained by healthcare providers and health insurers, supplemented by overdose deaths identified from the National Death Index. The terms for overdose are combined following validated rules as developed in companion studies. The study is being conducted in parallel with a prospective questionnaire-based cohort study of the same risks.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Opioid overdose - fatal and nonfatal
Time Frame: Retrospective review over period from October 1, 2006 to December 31, 2017
Opioid overdose as identified in insurance claims, electronic medical records and National Death Index records.
Secondary Outcomes
No secondary outcomes reported