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

Member Companies of the Opioid PMR Consortium808,455 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

808,455

Conditions

Opioid Overdose

Interventions

Observation onlyOTHER

No intervention.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

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

Locations (4)

HealthCore Inc

Wilmington, Delaware, United States

Optum

Boston, Massachusetts, United States

Kaiser Permanente Northwest

Portland, Oregon, United States

Vanderbilt University

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Opioid overdose - fatal and nonfatal

Opioid overdose as identified in insurance claims, electronic medical records and National Death Index records.

Time frame: Retrospective review over period from October 1, 2006 to December 31, 2017

Data from ClinicalTrials.gov

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