Opioid OverdoseNCT02662153
Incidence and Predictors of Opioid Overdose and Death Among Long-Term Users of Opioid Analgesics
An observational study of Opioid Overdose, run by Member Companies of the Opioid PMR Consortium at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Opioid Overdose
- What is being tested?
- Observation only
- How many people
- 808,455 participants
- Where
- 4 sitesUnited States
- Study dates
- 2 May 2019to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Experience of opioid overdose in the six months preceding inclusion
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Optum
Boston, Massachusetts, 02215
Vanderbilt University
Nashville, Tennessee, 37235
Kaiser Permanente Northwest
Portland, Oregon, 97227
HealthCore Inc
Wilmington, Delaware, 19801
About this study
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
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.
Read the 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.
- Conditions
- Opioid Overdose
- Being tested
- Observation only
- Medical subject headings
- Opiate Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation onlyOther
No intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Observation only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid overdose - fatal and nonfatal
Opioid overdose as identified in insurance claims, electronic medical records and National Death Index records.
Measured: Retrospective review over period from October 1, 2006 to December 31, 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2016 (estimated)
- Study start2 May 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid OverdoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 808,455 participants (actual)
Sponsor and investigators
- Lead sponsor
- Member Companies of the Opioid PMR Consortium
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kaiser Permanente, HealthCore, Inc., Vanderbilt University, World Health Information Science Consultants, LLC, Optum, Inc.
- Responsible party
- Sponsor
- Investigators
- Kenneth R Petronis, Study chair, Epi Ideas LLCJohn D Seeger, Principal investigator, Optum, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662153
- Sponsor's protocol ID
- Observational Study 3033-2
- Other IDs
- Study 3033-2
- Status last verified
- Jul 2022
- First submitted
- 20 Jan 2016
- Last updated
- 14 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02662153
- Acronym / sponsor ID
- Observational Study 3033-2
- Conditions
- Opioid Overdose
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 808,455 participants (actual)
- Lead sponsor
- Member Companies of the Opioid PMR ConsortiumIndustry (pharma, biotech, devices)
- Collaborators
- Kaiser Permanente, HealthCore, Inc., Vanderbilt University, World Health Information Science Consultants, LLC, Optum, Inc.
- Study start
- 2 May 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 25 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Long-term opioid-use cohort | – | Other: Observation onlyPersons 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. |
| IR/SA to ER/LA Switchers | – | Other: Observation onlyPersons who have switched to or added on an ER/LA product after stable use of an IR/SA opioid regimen. |
| IR/SA to IR/SA Switchers | – | Other: Observation onlyPersons who have switched to or added on a new IR/SA opioid after stable use of a different IR/SA opioid regimen. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Experience of opioid overdose in the six months preceding inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation onlyNo intervention. | Other | IR/SA to ER/LA Switchers, IR/SA to IR/SA Switchers, Long-term opioid-use cohort |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth R Petronis study chair
Epi Ideas LLC
John D Seeger principal investigator
Optum, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Overdose, run by Member Companies of the Opioid PMR Consortium at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid overdose - fatal and nonfatal (time frame: Retrospective review over period from October 1, 2006 to December 31, 2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2022.