A Prospective Investigation of the Risks of Opioid Misuse, Abuse, and Addiction Among Patients Treated With Opioids for the Treatment of Chronic Pain
CompletedNCT02751762
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official title
- A Prospective Investigation of the Risks of Opioid Misuse, Abuse, and Addiction Among Patients Treated With Opioids for the Treatment of Chronic Pain
- Conditions
- Opioid-Related Disorders
- Opiate Addiction
- Narcotic Abuse
- Drug Abuse
- Interventions
- Other: Observation Only
- Sponsor
- Member Companies of the Opioid PMR Consortium
- Collaborators
- Kaiser Permanente
- Start date
- 2017-11-01
- Primary completion
- 2021-10-01
- Sex
- All
- Age range
- from 18 Years to 79 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02751762