NCT02667210

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
590

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2014

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 6, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2017

Completed
Last Updated

April 15, 2020

Status Verified

April 1, 2020

Enrollment Period

2.6 years

First QC Date

January 21, 2016

Last Update Submit

April 14, 2020

Conditions

Opioid-Related DisordersOpiate AddictionNarcotic AbuseDrug Abuse

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    Retrospective review over 24 month period starting 6 months prior to first dispensing in 2012 and 18 month follow-up

Study Arms (4)

No shopping behavior

Other: Medical Record Review

Minimal shopping behavior

Other: Medical Record Review

Marked shopping behavior

Other: Medical Record Review

Extensive shopping behavior

Other: Medical Record Review

Interventions

Medical Record ReviewOTHER

Medical Record Review of Behaviors Suggestive of Misuse, Diversion, Abuse and/or Addiction

Extensive shopping behaviorMarked shopping behaviorMinimal shopping behaviorNo shopping behavior

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients identified from the HealthCore Integrated Research Database

You may qualify if:

  • Patients 18 years or older on the date of first IR or ER/LA opioid dispensing in 2012
  • 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.
  • 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.
  • Patients with continuous enrollment during the follow-up period of 18 months

You may not qualify if:

  • Patients who cannot be classified into one of the four a priori defined doctor/pharmacy shopping categories
  • Patients for whom no medical records can be accessed
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Opioid-Related DisordersNarcotic-Related DisordersSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Soledad Cepeda, MD, PhD

    Janssen Research & Development, LLC

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2016

First Posted

January 28, 2016

Study Start

November 6, 2014

Primary Completion

June 21, 2017

Study Completion

June 21, 2017

Last Updated

April 15, 2020

Record last verified: 2020-04