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Completed

NCT Number: NCT02662153

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

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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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

HealthCore Inc, Wilmington, Delaware, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observation only

Other

No intervention.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Member Companies of the Opioid PMR Consortium

Industry

Collaborators

  • HealthCore, Inc.
  • Kaiser Permanente
  • Optum, Inc.
  • Vanderbilt University
  • World Health Information Science Consultants, LLC

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 25, 2016
Registry last updated
Jul 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.