Incidence and Predictors of Opioid Overdose and Death Among Long-Term Users of Opioid Analgesics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

808455 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-02

Study Completion Date

2021-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Opioid Overdose

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

* 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