Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02662153
Recruitment Status : Active, not recruiting
First Posted : January 25, 2016
Last Update Posted : April 15, 2020
Sponsor:
Collaborators:
Kaiser Permanente
HealthCore, Inc.
Vanderbilt University
World Health Information Science Consultants, LLC
Optum, Inc.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Opioid Overdose Other: Observation only

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 800000 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : May 2, 2019
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Group/Cohort Intervention/treatment
Long-term opioid-use cohort
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.
Other: Observation only
No intervention.

IR/SA to ER/LA Switchers
Persons who have switched to or added on an ER/LA product after stable use of an IR/SA opioid regimen.
Other: Observation only
No intervention.

IR/SA to IR/SA Switchers
Persons who have switched to or added on a new IR/SA opioid after stable use of a different IR/SA opioid regimen.
Other: Observation only
No intervention.




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The source populations will be those members of the selected health plans and insurance programs identified for which full demographic, provider, facility and pharmacy data are available, and in which protected health information (PHI) can be linked to death certificate information.

The four large healthcare systems that have established electronic databases for studying coded terminology outcomes selected for this study are: Kaiser Permanente Northwest; HealthCore, Inc. with access to commercial insurance data; Optum with access to commercial insurance data; and Vanderbilt University with access to Medicaid data for the State of Tennessee.

Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02662153


Locations
Layout table for location information
United States, Delaware
HealthCore Inc
Wilmington, Delaware, United States, 19801
United States, Massachusetts
Optum
Boston, Massachusetts, United States, 02215
United States, Oregon
Kaiser Permanente Northwest
Portland, Oregon, United States, 97227
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37235
Sponsors and Collaborators
Member Companies of the Opioid PMR Consortium
Kaiser Permanente
HealthCore, Inc.
Vanderbilt University
World Health Information Science Consultants, LLC
Optum, Inc.
Investigators
Layout table for investigator information
Study Chair: David Kern Janssen Research & Development, LLC
Principal Investigator: Alexander Walker WHISCON, Scientific Steering Committee
Layout table for additonal information
Responsible Party: Member Companies of the Opioid PMR Consortium
ClinicalTrials.gov Identifier: NCT02662153    
Other Study ID Numbers: Observational Study 3033-2
Study 3033-2 ( Other Identifier: Member Companies of the Opioid PMR Consortium )
First Posted: January 25, 2016    Key Record Dates
Last Update Posted: April 15, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
Layout table for MeSH terms
Drug Overdose
Substance-Related Disorders
Chemically-Induced Disorders