Overview

This trial is active, not recruiting.

Conditions opioid-related disorders, opiate addiction, narcotic abuse, drug abuse
Treatment medical record review
Sponsor Member Companies of the Opioid PMR Consortium
Collaborator HealthCore, Inc.
End date June 2017
Trial size 590 participants
Trial identifier NCT02667210, 2065-4C, Observational Study 4C

Summary

To assess whether the percentage of patients with behaviors suggestive of misuse, diversion, abuse and/or addiction described in the medical record increases across pre-defined categories of increasing doctor/pharmacy shopping behavior.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective retrospective
Arm
medical record review
Medical Record Review of Behaviors Suggestive of Misuse, Diversion, Abuse and/or Addiction
medical record review
Medical Record Review of Behaviors Suggestive of Misuse, Diversion, Abuse and/or Addiction
medical record review
Medical Record Review of Behaviors Suggestive of Misuse, Diversion, Abuse and/or Addiction
medical record review
Medical Record Review of Behaviors Suggestive of Misuse, Diversion, Abuse and/or Addiction

Primary Outcomes

Measure
The percentages of patients in each category having at least one and up to 34 (all) of the prespecified list of behaviors suggestive of misuse, diversion, abuse and/or addiction in their medical records
time frame: Retrospective review over 24 month period starting 6 months prior to first dispensing in 2012 and 18 month follow-up
The correlation among the behaviors suggestive of misuse, diversion, abuse and/or addiction
time frame: Retrospective review over 24 month period starting 6 months prior to first dispensing in 2012 and 18 month follow-up

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Patients 18 years or older on the date of first IR or ER/LA opioid dispensing in 2012 2. Patients with at least two dispensings of any IR or ER/LA opioid. The first of these dispensings will have occurred in 2012 and an additional dispensing within 18 months after the first. 3. Continuous, fully insured enrollment with medical and pharmacy eligibility in a health plan included in the HealthCore Integrated Research Database (HIRD) for at least six months prior to the start of the follow-up period. 4. Patients with continuous enrollment during the follow-up period of 18 months Exclusion Criteria: 1. Patients who cannot be classified into one of the four a priori defined doctor/pharmacy shopping categories 2. Patients for whom no medical records can be accessed 3. Patients with a known history of abuse identified through the administrative claims data will be excluded because HealthCore is not permitted to request their medical records.

Additional Information

Official title Retrospective Cohort Study to Evaluate the Relation Between Doctor/Pharmacy Shopping and Outcomes Suggestive of Misuse, Diversion, Abuse and/or Addiction by Medical Record Review
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 4C), the association of doctor/pharmacy shopping behavior with misuse, diversion, abuse and/or addiction will be assessed by reviewing medical charts in a sample of patients within specific categories of a priori defined doctor/pharmacy shopping. The four categories of doctor/pharmacy shopping behaviors identified and defined in Study 4A and will be applied to Study 4C. The medical chart is a rich source of information about the patient's medical conditions and behaviors suggestive of misuse and abuse. Medical record review for behaviors suggestive of misuse and abuse in patients with chronic pain discriminates between patients with and without opioid use disorders. Therefore, Study 4C was designed to utilize an insurance/health plan database (HealthCore Integrated Research Database [HIRD]) with access to medical records, to evaluate the association of a priori defined categories of doctor/pharmacy shopping and behaviors suggestive of misuse, diversion, abuse and/or addiction.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Member Companies of the Opioid PMR Consortium.