Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to formulate definitions of doctor/pharmacy shopping and evaluate its association with abuse/addiction


Clinical Trial 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, abuse and/or addiction.

Study #2065-4 consists of three sub-studies, Study 4A, Study 4B, and Study 4C. In the current study (#2065 sub-study, Study 4A), the IMS® LRx database, a longitudinal pharmacy database that captures both third-party and self-pay transactions, will be linked to the PharMetrics Plus™ database, which contains provider, facility and pharmacy claims. From these databases, patients with shopping behavior will be identified and evaluated against an algorithm for abuse/addiction that will be developed and validated in PMR Study #2065-3B. Study #2065-3B will review the literature for health information suggestive of abuse/addiction in medical charts and medical claims. Then, through iterative processes that involve experts reviewing claims profiles and medical charts, text searches of medical records using natural language processing and supervised machine learning will identify and create a compilation of codes and health information with the best specificity and sensitivity to identify patients with opioid abuse/addiction. The compilation of codes and health information will be used to develop the algorithm that Study 4A will apply to define abuse/addiction. Restricting the validation of shopping behavior to only patients with diagnoses related to abuse would ignore the population with undiagnosed abuse. By supplementing ICD-9 codes with other information available on claims (e.g., addiction treatments, emergency visits) to define abuse/addiction, the measurement bias will be decreased and the estimates of the association of shopping behavior with abuse/addiction will be more valid. Categories of doctor shopping will be derived from the population distributions of the multiple variables analyzed for opioid users. The 4 categories will range from no shopping behavior (lowest level) to extensive shopping behavior (most extreme). The specifics of how the categories will be defined will be driven by the data. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02668549
Study type Observational
Source Member Companies of the Opioid PMR Consortium
Contact
Status Completed
Phase
Start date February 5, 2015
Completion date August 9, 2017

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03950492 - Feasibility of Deep Brain Stimulation as a Novel Treatment for Refractory Opioid Use Disorder N/A
Completed NCT00000335 - Activity Monitoring Assessment of Opiate Withdrawal - 4 Phase 2
Active, not recruiting NCT03949764 - The Kentucky Viral Hepatitis Treatment Study Phase 4
Enrolling by invitation NCT06084221 - Fatal Overdose Review Teams - Research to Enhance Surveillance Systems N/A
Completed NCT02978417 - Feasibility Study of Extended-release Naltrexone (Vivitrol) in Drug Court Settings Phase 4
Withdrawn NCT03137030 - A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of Different Amounts of Tablets of a New and a Marketed Tablet Formulation in Healthy Adults Phase 1
Withdrawn NCT03137017 - A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of a New and a Marketed Tablet Formulation Under Fasted and Fed Conditions in Healthy Adults Phase 1
Completed NCT02282306 - Phone Interview to Prevent Recurring Opioid Overdoses N/A
Completed NCT00710385 - Abuse Liability of Suboxone Versus Subutex Phase 3
Completed NCT00142935 - Effectiveness of Opiate Replacement Therapy Administered Prior to Release From a Correctional Facility - 1 N/A
Completed NCT00218309 - Effects of Pre-Session Supplemental Hydromorphone on Drug Seeking Behavior in Opioid Dependent Individuals Phase 2
Terminated NCT00000243 - Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals Who Are Maintained on Methadone N/A
Completed NCT00067184 - Fetal Neurobehavioral Development in Methadone Maintained Pregnancies
Completed NCT00000264 - Subjective/Psychomotor/ Effects of Combined Alcohol & Nitrous Oxide - 16 N/A
Completed NCT00000257 - Effects of Alcohol History on Effects of Nitrous Oxide - 9 N/A
Completed NCT00000306 - Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3 Phase 2
Completed NCT00000279 - Novel Medications for Opiate Detoxification - 4 Phase 2
Completed NCT00000249 - Effects of Subanesthetic Concentrations of Nitrous Oxide - 1 Phase 2
Recruiting NCT04933084 - Pre-operative Education Modalities to Decrease Opioid Use N/A
Recruiting NCT03610672 - Mobile Intervention for Young Opioid Users N/A