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

Opioid Overdose Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02662153
• Other study ID #: Observational Study 3033-2
• Secondary ID: Study 3033-2
• Status: Completed
• Start date: May 2, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2022
• Source: Member Companies of the Opioid PMR Consortium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 808455
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Overdose
• Opiate Overdose
• Opioid Overdose

Intervention

Other:
• Observation only
No intervention.

Locations

Country	Name	City	State
United States	Optum	Boston	Massachusetts
United States	Vanderbilt University	Nashville	Tennessee
United States	Kaiser Permanente Northwest	Portland	Oregon
United States	HealthCore Inc	Wilmington	Delaware

Sponsors (6)

Lead Sponsor	Collaborator
Member Companies of the Opioid PMR Consortium	HealthCore, Inc., Kaiser Permanente, Optum, Inc., Vanderbilt University, World Health Information Science Consultants, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid overdose - fatal and nonfatal	Opioid overdose as identified in insurance claims, electronic medical records and National Death Index records.	Retrospective review over period from October 1, 2006 to December 31, 2017