NCT02662153

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

Incidence and Predictors of Opioid Overdose and Death Among Users of Opioid Analgesics as Measured by Diagnoses and Death Records - a Retrospective Database Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 808,455 (actual)
• Sponsor: Member Companies of the Opioid PMR Consortium · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Opioid Overdose

Interventions

Type	Name	Description
OTHER	Observation only	No intervention.

Timeline

• Start date: 2019-05-02
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2016-01-25
• Last updated: 2022-07-14

Locations

4 sites across 1 country: United States