NCT02662153

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
808,455

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 25, 2016

Completed
3.3 years until next milestone

Study Start

First participant enrolled

May 2, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

July 14, 2022

Status Verified

July 1, 2022

Enrollment Period

2.2 years

First QC Date

January 20, 2016

Last Update Submit

July 12, 2022

Conditions

Opioid Overdose

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

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

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

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

Interventions

Observation onlyOTHER

No intervention.

IR/SA to ER/LA SwitchersIR/SA to IR/SA SwitchersLong-term opioid-use cohort

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

HealthCore Inc

Wilmington, Delaware, 19801, United States

Location

Optum

Boston, Massachusetts, 02215, United States

Location

Kaiser Permanente Northwest

Portland, Oregon, 97227, United States

Location

Vanderbilt University

Nashville, Tennessee, 37235, United States

Location

MeSH Terms

Conditions

Opiate Overdose

Condition Hierarchy (Ancestors)

Drug OverdosePrescription Drug MisuseDrug MisuseSubstance-Related DisordersChemically-Induced DisordersOpioid-Related DisordersNarcotic-Related DisordersMental Disorders

Study Officials

  • Kenneth R Petronis

    Epi Ideas LLC

    STUDY CHAIR

  • John D Seeger

    Optum, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2016

First Posted

January 25, 2016

Study Start

May 2, 2019

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

July 14, 2022

Record last verified: 2022-07

Locations

US(4)