Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 12:21 AM
NCT ID:
NCT02667158
Brief Summary:
To evaluate the reasons patients go to more than one prescriber or more than one pharmacy to obtain prescriptions opioids and assess whether the percentage of patients reporting misuse, abuse and/or diversion increases across defined categories of doctor/pharmacy shopping as defined in Study 4A.
Detailed Description:
Based on a review of the literature, the Food and Drug Administration (FDA) concluded that more data are needed regarding the serious risks of misuse, abuse, addiction, overdose, and death associated with the long-term use of extended release/long acting (ER/LA) opioid analgesics. Thus, the FDA is requiring that ER/LA opioid analgesic drug sponsors conduct post-marketing studies to assess these risks. The four observational post-marketing requirement (PMR) studies are labeled Study #2065-1, Study #2065-2, Study #2065-3, and Study #2065-4.
The objective of PMR Study #2065-4 is to define and validate doctor/pharmacy shopping as outcomes suggestive of misuse, diversion, abuse and/or addiction.
Study #2065-4 consists of three sub-studies, Study 4A, Study 4B, and Study 4C. In the current study (#2065-4 sub-study, Study 4B), the association between doctor/pharmacy shopping behavior and misuse, diversion and abuse will be assessed by surveying patients within the a priori defined four categories of shopping behaviors. The four categories of shopping behaviors identified and defined in Study 4A will be applied to Study 4B. Asking patients directly about their behaviors related to misuse and abuse will provide us with the patient's perspective that is unavailable in Study 4A. Surveying patients regarding misuse and abuse requires the use of an instrument that has undergone a validation process to ensure that misuse and abuse are being measured. Study 4B will utilize the Prescription Opioid Misuse and Abuse Questionnaire (POMAQ) that will be validated in PMR Study #2065-2A. An administrative claims database will be used to identify the eligible patient population using their pharmacy claims for immediate release (IR) or ER/LA opioid analgesics to determine the number of prescribers and number of pharmacies they visit. Consenting patients will be asked to complete an online survey that includes the POMAQ to self-report their behaviors of misuse, abuse and/or diversion. It is hypothesized that as the likelihood of doctor/pharmacy shopping behavior increases the risk of misuse, abuse and/or diversion.
Study:
NCT02667158
Study Brief:
Protocol Section:
NCT02667158