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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,085

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2014

Longer than P75 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 7, 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
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2018

Completed
Last Updated

April 15, 2020

Status Verified

April 1, 2020

Enrollment Period

4.1 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)

  • Self-reported reasons that patients go to more than one prescriber or more than one pharmacy, stratified by doctor/pharmacy shopping categories

    Day 1, based upon single patient survey completed online or via telephone

  • Responses suggestive of misuse and/or abuse on the POMAQ.

    Day 1, based upon single patient survey completed online or via telephone

Study Arms (4)

No shopping behavior

Patients will be grouped into one of the categories based on the most recent 18 months of data available at the time the patient sample is identified

Other: Survey to Eval Relation between Shopping and Misuse, Abuse

Minimal shopping behavior

Patients will be grouped into one of the categories based on the most recent 18 months of data available at the time the patient sample is identified

Other: Survey to Eval Relation between Shopping and Misuse, Abuse

Marked shopping behavior

Patients will be grouped into one of the categories based on the most recent 18 months of data available at the time the patient sample is identified

Other: Survey to Eval Relation between Shopping and Misuse, Abuse

Extensive shopping behavior

Patients will be grouped into one of the categories based on the most recent 18 months of data available at the time the patient sample is identified

Other: Survey to Eval Relation between Shopping and Misuse, Abuse

Interventions

Survey to Eval Relation between Shopping and Misuse, AbuseOTHER

A Survey Study to Evaluate the Relation Between Doctor/Pharmacy Shopping and Outcomes Suggestive of Misuse, Abuse and/or Diversion

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 (18 years of age or older) identified from the HealthCore Integrated Research Database (HIRD) with at least two pharmacy claims for any IR or ER/LA opioid analgesic in the most recent 18 months of claims data

You may qualify if:

  • At least two pharmacy claims for any IR or ER/LA opioid analgesic in the most recent 18 months of claims data.
  • Based on claims for the most recent 18 months of data, meet classification criteria for one of the four a priori defined doctor/pharmacy shopping categories.
  • Currently active, commercially-insured, survey eligible with medical and pharmacy benefits with a health plan included in the HealthCore Integrated Research Database (HIRD) at the time the sample list is extracted.
  • At least 18 years of age as of the date of the first IR or ER/LA opioid dispensing in the most recent 18 months of claims data.
  • A telephone number or address known to HealthCore.

You may not qualify if:

  • Patients who appear on the HealthCore "Do-not-call" list.
  • Patients with a known history of abuse
  • Patients who do not indicate that they have read about all pertinent aspects of the study and agree to participate.
  • Patients who fail to validate their name and/or date of birth
  • Patients who are unable to understand the survey questions as designed (e.g., non-English speaking, etc.).
  • Patients who fail other study-specific screening questions.

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 7, 2014

Primary Completion

December 19, 2018

Study Completion

December 19, 2018

Last Updated

April 15, 2020

Record last verified: 2020-04