- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02751762
A Prospective Investigation of the Risks of Opioid Misuse, Abuse, and Addiction Among Patients Treated With Opioids for the Treatment of Chronic Pain
July 12, 2022 updated by: Member Companies of the Opioid PMR Consortium
The purpose of this study is to quantify the serious risks of prescription opioid misuse or abuse or opioid use disorder (OUD) associated with the long term use of opioid analgesics for management of chronic pain, among patients prescribed opioid products.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Detailed Description
The Food and Drug Administration (FDA) has asked the companies that are New Drug Application (NDA) holders of extended-release/long-acting (ER/LA) opioids to conduct one or more studies to provide quantitative estimates of the serious risks of prescription opioid misuse or abuse or opioid use disorder associated with long-term use of opioid analgesics for management of chronic pain, among patients prescribed opioid products.
Although abuse and misuse of prescription opioids have increased over the past decade, there is debate about the magnitude of misuse, abuse, and addiction among patients who are treated with prescription opioids for chronic pain.
Further, although there appears to be comorbidity of opioid use disorders with other substance use and psychiatric disorders, there is insufficient data to estimate how the risk of these outcomes varies by the presence of risk factors among patients treated with opioids long-term.
This study seeks to fill that gap.
The primary objective is to quantify the serious risks of prescription opioid misuse or abuse or OUD associated with long-term use of opioid analgesics for management of chronic pain among patients prescribed opioid products.
Patients will be recruited from seven Health Care System Research Network (HCSRN) sites; one U.S. Department of Veterans Affairs (VA) site; and clinics participating in two Primary Care Practice-Based Research Network sites.
The data sources for the proposed study will be: 1) patient reported outcomes through in-person interviews (or phone if unavailable to participate in-person), 2) web-based assessments (or phone if unable to complete via web), and 3) electronic medical record and claims data.
The study design includes two components: 1) a prospective longitudinal study of patients who have recently initiated long-term opioid therapy or initiated ER/LA opioid therapy, and 2) a cross-sectional study of patients who have been treated with opioids (including at least one ER/LA opioid) for at least one year.
Study Type
Observational
Enrollment (Anticipated)
3632
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Oregon
-
Portland, Oregon, United States, 97210
- Kaiser Permanente Northwest
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Washington
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Seattle, Washington, United States, 98112
- Kaiser Permanente Washington
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Of the approximately 2300 eligible subjects in the prospective study, approximately 2200 will be from the HCSRN sites, 25 from the VA, and a total of 100 from the PBRN sites.
Sampling and recruitment strategies for the cross-sectional study will parallel those used to identify the prospective sample.
Description
Eligibility Criteria for the Prospective Study
Inclusion Criteria:
- Initiation* of ER/LA opioid therapy that includes 28+ days of an ER/LA followed by a subsequent ER/LA prescription (ER/LA initiators) or initiation** of long-term opioid therapy (LtOT - 90+ days of use) with ER/LA and/or Schedule II IR/SA opioids (LtOT initiators).
- Age 18-79 years at incident prescription
- Enrolled in the health plan (HCSRN sites) or regularly receiving care in the health system (VA and PBRNs) for at least 12 months prior to incident use of opioids
- Ability to complete interview/self-administered questionnaires in English
Willing and able to provide informed consent
- Initiation or new use of ER/LA therapy defined as no ER/LA opioid use in the prior six-months ** Initiation or new LtOT use defined as no ER/LA or Schedule II IR/SA opioid use in the prior six-months
Exclusion Criteria:
- Not using an ER/LA or Schedule II IR/SA opioid at the time of recruitment or first interview (self-report)
- Cognitive impairment that interferes with the ability to consent or participate in the interview
- Unavailable for 12 months of follow-up (self-report)
- Receiving hospice care (EHR and recruitment screening)
- Diagnosis of a terminal illness in the prior 12 months per chart review or recruitment screening
- Existing opioid use disorder (ICD-9 and ICD-10 diagnosis codes)
- Medication assisted treatment with methadone or buprenorphine (self-report)
Eligibility Criteria - Cross Sectional Study:
Inclusion Criteria:
- Regular opioid use in the past year with at least 1 prescription for an ER/LA opioid. See Figure 4 for specifics on how these criteria are operationalized.
- Age 18-79 years at index prescription Enrolled in the health plan (HCSRN sites) or regularly receiving care in the health system (VA and PBRNs) for at least 12 months prior to index date.
- Ability to complete interview/self-administered questionnaires in English
- Willing and able to provide informed consent
Exclusion Criteria:
- Not using an opioid at the time of recruitment or first interview (self-report)
- Cognitive impairment that interferes with the ability to consent or participate in the interview
- Receiving hospice care (EHR and recruitment screening)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Prospective Longitudinal Cohort
Patients who have recently initiated long-term opioid therapy or initiated ER/LA opioid therapy
|
No Intervention
|
Cross-sectional Cohort
Patients who have been treated with opioids (including at least one ER/LA opioid) for greater than one year
|
No Intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prospective Longitudinal study: Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)
Time Frame: Change from baseline at up to one year
|
Estimation of the incidence of misuse and abuse associated with long-term use of opioids for chronic pain.
|
Change from baseline at up to one year
|
Prospective Longitudinal study: Psychiatric Research Interview for Substance and Mental Disorders, adapted for assessing addiction to opioid analgesics (PRISM-5-OP)
Time Frame: Change from baseline at one year
|
Estimation of the incidence of addiction associated with long-term use of opioids for chronic pain.
|
Change from baseline at one year
|
Cross sectional Study: Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)
Time Frame: Day 1 Assessment
|
Estimation of the prevalence of misuse and abuse associated with long term use of opioids for chronic pain.
|
Day 1 Assessment
|
Cross sectional Study: Psychiatric Research Interview for Substance and Mental Disorders, adapted for assessing addiction to opioid analgesics (PRISM-5-OP)
Time Frame: Day 1 Assessment
|
Estimation of the prevalence of addiction associated with long term use of opioids for chronic pain.
|
Day 1 Assessment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Kenneth R Petronis, Epi Ideas LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2017
Primary Completion (Actual)
October 1, 2021
Study Completion (Anticipated)
March 1, 2023
Study Registration Dates
First Submitted
April 6, 2016
First Submitted That Met QC Criteria
April 21, 2016
First Posted (Estimate)
April 26, 2016
Study Record Updates
Last Update Posted (Actual)
July 14, 2022
Last Update Submitted That Met QC Criteria
July 12, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Observational Study 3033-1
- Study 3033-1 (Other Identifier: Member Companies of the Opioid PMR Consortium)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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