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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02662153
Other study ID # Observational Study 3033-2
Secondary ID Study 3033-2
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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