Quantify the serious risks of misuse, abuse, and addiction associated with long-term use of opioid analgesics for management of chronic pain. | Final Protocol Submission: 11/2015 (completed) Study Completion: 10/2019 Final Report Submission: 03/2020 |
Measure the incidence and predictors of opioid overdose and death (OOD), as well as opioid abuse/addiction, using patient health records. | Final Protocol Submission: 11/2014 (completed) Study Completion: 04/2019 Final Report Submission: 09/2019 |
Assess the content validity and patient interpretation of the Prescription Opioid Misuse and Abuse Questionnaire (POMAQ). | Final Protocol Submission: 04/2015 (completed) Study Completion: 10/2015 (completed) Final Report Submission: 01/2016 (completed) |
Evaluate the validity and reproducibility of the Prescription Opioid Misuse and Abuse Questionnaire (POMAQ). | Final Protocol Submission: 04/2015 (completed) Study Completion: 10/2016 Final Report Submission: 02/2017 |
Validate measures of prescription opioid substance use disorder and addiction in patients who have received or are receiving opioid analgesics for chronic pain. | Final Protocol Submission: 04/2015 (completed) Study Completion: 12/2016 Final Report Submission: 05/2017 |
Develop and validate an algorithm using coded medical terminologies and other electronic health care data to identify opioid-related overdose and death. | Final Protocol Submission: 11/2014 (completed) Study Completion: 09/2016 Final Report Submission: 12/2016 |
Develop and validate an algorithm using coded medical terminologies to identify patients experiencing prescription opioid abuse or addiction, among patients receiving an ER/LA opioid analgesic. | Final Protocol Submission: 11/2014 (completed) Study Completion: 10/2016 Final Report Submission: 01/2017 |
Define and validate doctor and/or pharmacy shopping outcomes by examining their association with abuse and/or addiction, using coded medical terminologies and other electronic health care data. | Final Protocol Submission: 03/2015 (completed) Study Completion: 10/2017 Final Report Submission: 01/2018 |
Evaluate the association between doctor/pharmacy shopping outcomes and self-reported misuse and abuse using a validated patient survey. | Final Protocol Submission: 03/2015 (completed) Study Completion: 09/2018 Final Report Submission: 12/2018 |
Evaluate the association between doctor/pharmacy shopping outcomes and patient behaviors suggestive of misuse, abuse, and/or addiction using medical record review. | Final Protocol Submission: 03/2015 (completed) Study Completion: 03/2017 Final Report Submission: 06/2017 |
Conduct a clinical trial to estimate the serious risk for the development of hyperalgesia following the long-term use of high-dose ER/LA opioid analgesics for at least 1 year to treat chronic pain. Include an assessment of risk relative to efficacy. | Final Protocol Submission: 11/2014 (completed) Trial Completion: 02/2019 Final Report Submission: 08/2019 |