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

Completed

• Conditions: Opioid Overdose
• Interventions: Other: Observation only

• Registration Number: NCT02662153
• Lead Sponsor: Member Companies of the Opioid PMR Consortium

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 Timeline

• Study First Submitted: 2016-01-20
• Study First Submitted QC: 2016-01-22
• Study First Posted: 2016-01-25
• Study Start: 2019-05-02
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-12
• Last Update Posted: 2022-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 808455

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IR/SA to IR/SA Switchers	Observation only	Persons who have switched to or added on a new IR/SA opioid after stable use of a different IR/SA opioid regimen.
IR/SA to ER/LA Switchers	Observation only	Persons who have switched to or added on an ER/LA product after stable use of an IR/SA opioid regimen.
Long-term opioid-use cohort	Observation only	Persons who have received 70 or more days of Schedule II opioid dispensed in a 90-day period, after at least 183 days with no opioid dispensing.

Primary Outcome Measures

Name	Time	Method
Opioid overdose - fatal and nonfatal	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.

Trial Locations

Locations (4)

Optum; 🇺🇸 Boston, Massachusetts, United States

Kaiser Permanente Northwest; 🇺🇸 Portland, Oregon, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States

HealthCore Inc; 🇺🇸 Wilmington, Delaware, United States