Opioid-Related DisordersNCT02668549
Cross-Sectional Study to Define and Validate "Doctor/Pharmacy Shopping" as Outcomes Suggestive of Abuse and/or Addiction
An observational study of Opioid-Related Disorders and Opiate Addiction, run by Member Companies of the Opioid PMR Consortium.
Trial summary
The purpose of this study is to formulate definitions of doctor/pharmacy shopping and evaluate its association with abuse/addiction Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse
- What is being tested?
- DB review for Doctor/Pharmacy Shopping Behavior
- How many people
- 164,923 participants
- Where
- No sites listed yet
- Study dates
- 5 Feb 2015to 9 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients (18 years of age or older) with data in both IMS LRx and PharMetrics Plus, who also have a minimum of two dispensings for IR or ER/LA opioids or two or more diuretic dispensings. The first of these dispensings will have occurred in 2012 and an additional dispensing within 18 months after the first. Dispensings will be determined from the IMS LRx database.
Who may be able to join
- Age ≥ 18 years
- Minimum of two dispensings for IR or ER/LA opioids or two or more diuretic dispensings
Who cannot join
- N/A
About this study
The purpose of this study is to formulate definitions of doctor/pharmacy shopping and evaluate its association with abuse/addiction
Read the 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, 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.
- Conditions
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Being tested
- DB review for Doctor/Pharmacy Shopping Behavior
- Medical subject headings
- Opioid-Related Disorders, Narcotic-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DB review for Doctor/Pharmacy Shopping BehaviorOther
Database review to evaluate of doctor/pharmacy shopping behaviors
| Study group | Role | What they receive |
|---|---|---|
| Patients with Opioid dispensings | Patients receiving two or more opioid dispensings within 18 months Receives: Other: DB review for Doctor/Pharmacy Shopping Behavior | |
| Patients with Diuretic dispensings (neg control) | Patients receiving two or more Diuretics dispensings within 18 months will serve as negative control Receives: Other: DB review for Doctor/Pharmacy Shopping Behavior |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers and proportions of patients with shopping behavior
Measured: Retrospective review over 18 month period starting with first dispensing in 2012
Sensitivity and predictive value of different levels of shopping behavior in relation with Algorithmically Identified Abuse and Addiction (AIAA)
Measured: Retrospective review over 18 month period starting with first dispensing in 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study start5 Feb 2015
- Primary completion9 Aug 2017
- Study completion9 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 164,923 participants (actual)
Sponsor and investigators
- Lead sponsor
- Member Companies of the Opioid PMR Consortium
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- World Health Information Science Consultants, LLC, IMS Health
- Responsible party
- Sponsor
- Investigators
- Soledad Cepeda, MD, PhD, Study chair, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02668549
- Sponsor's protocol ID
- Observational Study 3033-8
- Other IDs
- 3033-8
- Status last verified
- Apr 2020
- First submitted
- 20 Jan 2016
- Last updated
- 15 Apr 2020
- Results posted
- No
Publications
Walker AM, Weatherby LB, Cepeda MS, Bradford DC. Information on doctor and pharmacy shopping for opioids adds little to the identification of presumptive opioid abuse disorders in health insurance claims data. Subst Abuse Rehabil. 2019 Aug 1;10:47-55. doi: 10.2147/SAR.S201725. eCollection 2019.
PubMed 31534380
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Sectional Study to Define and Validate "Doctor/Pharmacy Shopping" as Outcomes Suggestive of Abuse and/or Addiction
- ClinicalTrials.gov ID
- NCT02668549
- Acronym / sponsor ID
- Observational Study 3033-8
- Conditions
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164,923 participants (actual)
- Lead sponsor
- Member Companies of the Opioid PMR ConsortiumIndustry (pharma, biotech, devices)
- Collaborators
- World Health Information Science Consultants, LLC, IMS Health
- Study start
- 5 Feb 2015 (actual)
- Primary completion
- 9 Aug 2017 (actual)
- Study completion
- 9 Aug 2017 (actual)
- First posted
- 29 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to formulate definitions of doctor/pharmacy shopping and evaluate its association with abuse/addiction
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, 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Opioid dispensings | – | Other: DB review for Doctor/Pharmacy Shopping BehaviorPatients receiving two or more opioid dispensings within 18 months |
| Patients with Diuretic dispensings (neg control) | – | Other: DB review for Doctor/Pharmacy Shopping BehaviorPatients receiving two or more Diuretics dispensings within 18 months will serve as negative control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients (18 years of age or older) with data in both IMS LRx and PharMetrics Plus, who also have a minimum of two dispensings for IR or ER/LA opioids or two or more diuretic dispensings. The first of these dispensings will have occurred in 2012 and an additional dispensing within 18 months after the first. Dispensings will be determined from the IMS LRx database.
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Minimum of two dispensings for IR or ER/LA opioids or two or more diuretic dispensings
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DB review for Doctor/Pharmacy Shopping BehaviorDatabase review to evaluate of doctor/pharmacy shopping behaviors | Other | Patients with Diuretic dispensings (neg control), Patients with Opioid dispensings |
Primary outcome
Numbers and proportions of patients with shopping behavior
Time frame: Retrospective review over 18 month period starting with first dispensing in 2012
Sensitivity and predictive value of different levels of shopping behavior in relation with Algorithmically Identified Abuse and Addiction (AIAA)
Time frame: Retrospective review over 18 month period starting with first dispensing in 2012
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
- Derived from this study: PubMed 31534380Walker AM, Weatherby LB, Cepeda MS, Bradford DC. Information on doctor and pharmacy shopping for opioids adds little to the identification of presumptive opioid abuse disorders in health insurance claims data. Subst Abuse Rehabil. 2019 Aug 1;10:47-55. doi: 10.2147/SAR.S201725. eCollection 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soledad Cepeda, MD, PhD study chair
Janssen Research & Development, LLC
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid-Related Disorders and Opiate Addiction, run by Member Companies of the Opioid PMR Consortium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers and proportions of patients with shopping behavior (time frame: Retrospective review over 18 month period starting with first dispensing in 2012). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02668549, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2020.