Opioid-Related DisordersNCT02667158
A Survey to Eval the Relation Between Doctor/Pharmacy Shopping and Outcomes Suggestive of Misuse, Abuse and/or Diversion
An observational study of Opioid-Related Disorders and Opiate Addiction, run by Member Companies of the Opioid PMR Consortium.
Trial 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. 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?
- Survey to Eval Relation between Shopping and Misuse, Abuse
- How many people
- 1,085 participants
- Where
- No sites listed yet
- Study dates
- 7 Nov 2014to 19 Dec 2018
- 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: 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
Who may be able to join
- Patients must meet all of the following inclusion criteria:
- 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.
Who cannot join
- 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.
About this study
Official title: A Survey Study to Evaluate the Relation Between Doctor/Pharmacy Shopping and Outcomes Suggestive of Misuse, Abuse and/or Diversion
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.
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, 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 4B), the association between doctor/pharmacy shopping behavior and misuse, diversion and abuse will be assessed by surveying patients within the a priori defined four categories of shopping behaviors. The four categories of shopping behaviors identified and defined in Study 4A will be applied to Study 4B. Asking patients directly about their behaviors related to misuse and abuse will provide us with the patient's perspective that is unavailable in Study 4A. Surveying patients regarding misuse and abuse requires the use of an instrument that has undergone a validation process to ensure that misuse and abuse are being measured. Study 4B will utilize the Prescription Opioid Misuse and Abuse Questionnaire (POMAQ) that will be validated in PMR Study #2065-2A. An administrative claims database will be used to identify the eligible patient population using their pharmacy claims for immediate release (IR) or ER/LA opioid analgesics to determine the number of prescribers and number of pharmacies they visit. Consenting patients will be asked to complete an online survey that includes the POMAQ to self-report their behaviors of misuse, abuse and/or diversion. It is hypothesized that as the likelihood of doctor/pharmacy shopping behavior increases the risk of misuse, abuse and/or diversion.
- Conditions
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Being tested
- Survey to Eval Relation between Shopping and Misuse, Abuse
- 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.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: Survey to Eval Relation between Shopping and Misuse, Abuse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported reasons that patients go to more than one prescriber or more than one pharmacy, stratified by doctor/pharmacy shopping categories
Measured: Day 1, based upon single patient survey completed online or via telephone
Responses suggestive of misuse and/or abuse on the POMAQ.
Measured: Day 1, based upon single patient survey completed online or via telephone
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study start7 Nov 2014
- Primary completion19 Dec 2018
- Study completion19 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,085 participants (actual)
Sponsor and investigators
- Lead sponsor
- Member Companies of the Opioid PMR Consortium
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- HealthCore, Inc.
- Responsible party
- Sponsor
- Investigators
- Soledad Cepeda, MD, PhD, Study chair, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02667158
- Sponsor's protocol ID
- Observational Study 3033-9
- Other IDs
- 3033-9
- Status last verified
- Apr 2020
- First submitted
- 21 Jan 2016
- Last updated
- 15 Apr 2020
- Results posted
- No
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
- A Survey Study to Evaluate the Relation Between Doctor/Pharmacy Shopping and Outcomes Suggestive of Misuse, Abuse and/or Diversion
- ClinicalTrials.gov ID
- NCT02667158
- Acronym / sponsor ID
- Observational Study 3033-9
- Conditions
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,085 participants (actual)
- Lead sponsor
- Member Companies of the Opioid PMR ConsortiumIndustry (pharma, biotech, devices)
- Collaborators
- HealthCore, Inc.
- Study start
- 7 Nov 2014 (actual)
- Primary completion
- 19 Dec 2018 (actual)
- Study completion
- 19 Dec 2018 (actual)
- First posted
- 28 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.
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.
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, 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 4B), the association between doctor/pharmacy shopping behavior and misuse, diversion and abuse will be assessed by surveying patients within the a priori defined four categories of shopping behaviors. The four categories of shopping behaviors identified and defined in Study 4A will be applied to Study 4B. Asking patients directly about their behaviors related to misuse and abuse will provide us with the patient's perspective that is unavailable in Study 4A. Surveying patients regarding misuse and abuse requires the use of an instrument that has undergone a validation process to ensure that misuse and abuse are being measured. Study 4B will utilize the Prescription Opioid Misuse and Abuse Questionnaire (POMAQ) that will be validated in PMR Study #2065-2A. An administrative claims database will be used to identify the eligible patient population using their pharmacy claims for immediate release (IR) or ER/LA opioid analgesics to determine the number of prescribers and number of pharmacies they visit. Consenting patients will be asked to complete an online survey that includes the POMAQ to self-report their behaviors of misuse, abuse and/or diversion. It is hypothesized that as the likelihood of doctor/pharmacy shopping behavior increases the risk of misuse, abuse and/or diversion.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No shopping behavior | – | Other: Survey to Eval Relation between Shopping and Misuse, AbusePatients 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 |
| Minimal shopping behavior | – | Other: Survey to Eval Relation between Shopping and Misuse, AbusePatients 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 |
| Marked shopping behavior | – | Other: Survey to Eval Relation between Shopping and Misuse, AbusePatients 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 |
| Extensive shopping behavior | – | Other: Survey to Eval Relation between Shopping and Misuse, AbusePatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.).
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 |
|---|---|---|
| Survey to Eval Relation between Shopping and Misuse, AbuseA Survey Study to Evaluate the Relation Between Doctor/Pharmacy Shopping and Outcomes Suggestive of Misuse, Abuse and/or Diversion | Other | Extensive shopping behavior, Marked shopping behavior, Minimal shopping behavior, No shopping behavior |
Primary outcome
Self-reported reasons that patients go to more than one prescriber or more than one pharmacy, stratified by doctor/pharmacy shopping categories
Time frame: Day 1, based upon single patient survey completed online or via telephone
Responses suggestive of misuse and/or abuse on the POMAQ.
Time frame: Day 1, based upon single patient survey completed online or via telephone
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.
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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 6 inclusion and 6 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?
Self-reported reasons that patients go to more than one prescriber or more than one pharmacy, stratified by doctor/pharmacy shopping categories (time frame: Day 1, based upon single patient survey completed online or via telephone). 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?
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.