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A Prospective Investigation of the Risks of Opioid Misuse, Abuse, and Addiction Among Patients Treated With Extended-release/Long Acting (ER/LA) Opioids for the Treatment of Chronic Pain

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ClinicalTrials.gov Identifier: NCT02751762
Recruitment Status : Recruiting
First Posted : April 26, 2016
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
Member Companies of the Opioid PMR Consortium

Brief Summary:
The purpose of this study is to quantify the serious risks of misuse, abuse, and addiction associated with long-term use of opioid analgesics for management of chronic pain, among patients prescribed ER/LA opioid products.

Condition or disease Intervention/treatment
Opioid-Related Disorders Opiate Addiction Narcotic Abuse Drug Abuse Other: Prescription Opioid Misuse and Abuse Questionnaire (POMAQ). Other: Psychiatric Research Interview for Substance and Mental Disorders, adapted for assessing addiction to opioid analgesics (PRISM-5-Op). Other: Events in Medical Records

Detailed Description:
The Food and Drug Administration (FDA) has asked the companies that are New Drug Application (NDA) holders of extended-release/long-acting (ER/LA) opioids to conduct one or more studies to provide quantitative estimates of the serious risks of misuse, abuse, addiction, overdose, and death associated with long-term use of opioid analgesics for management of chronic pain, among patients prescribed ER/LA opioid products. Although abuse and misuse of prescription opioids have increased over the past decade, there is debate about the magnitude of misuse, abuse, and addiction among patients who are treated with opioids for chronic pain. Further, although there appears to be comorbidity of opioid use disorders with other substance use and psychiatric disorders, there is insufficient data to estimate how the risk of these outcomes varies by the presence of risk factors among patients treated with opioids long-term. This study seeks to fill that gap. The primary objective is to quantify the serious risks of misuse, abuse, and addiction associated with long-term use of opioid analgesics for management of chronic pain among patients prescribed ER/LA opioid products. Patients will be recruited from six Health Care System Research Network (HCSRN) sites; one U.S. Department of Veterans Affairs (VA) site, and clinics participating in 2 Primary Care Practice-Based Research Network sites. The data sources for the proposed study will be: 1) patient reported outcomes through in-person interviews (or phone if unavailable to participate in-person), web-based assessments (or phone if unable to complete via web), and electronic medical record and claims data. The study design includes 2 components: 1) A prospective longitudinal study of patients who have recently initiated at least 30 days of ER/LA opioid therapy, and 2) A cross-sectional study of patients who have been treated with opioids (including at least one ER/LA opioid) for greater than 1 year.

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Study Type : Observational
Estimated Enrollment : 2530 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Investigation of the Risks of Opioid Misuse, Abuse, and Addiction Among Patients Treated With Extended-release/Long Acting (ER/LA) Opioids for the Treatment of Chronic Pain
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Group/Cohort Intervention/treatment
Prospective Longitudinal Cohort
Patients who have recently initiated at least 30 days of ER/LA opioid therapy
Other: Prescription Opioid Misuse and Abuse Questionnaire (POMAQ).
Not required

Other: Psychiatric Research Interview for Substance and Mental Disorders, adapted for assessing addiction to opioid analgesics (PRISM-5-Op).
Not required

Other: Events in Medical Records
Not required

Cross-sectional Cohort
Patients who have been treated with opioids (including at least one ER/LA opioid) for greater than 1 year
Other: Prescription Opioid Misuse and Abuse Questionnaire (POMAQ).
Not required

Other: Psychiatric Research Interview for Substance and Mental Disorders, adapted for assessing addiction to opioid analgesics (PRISM-5-Op).
Not required

Other: Events in Medical Records
Not required




Primary Outcome Measures :
  1. Prospective Longitudinal study: Prescription Opioid Misuse and Abuse Questionnaire (POMAQ) [ Time Frame: Change from baseline at up to one year ]
    Estimation of the incidence of misuse, abuse and addiction associated with long-term use of ER/LA opioids for chronic pain.

  2. Prospective Longitudinal study: Psychiatric Research Interview for Substance and Mental Disorders, adapted for assessing addiction to opioid analgesics (PRISM5Op) [ Time Frame: Change from baseline at one year ]
    Estimation of the incidence of misuse, abuse and addiction associated with long-term use of ER/LA opioids for chronic pain.

  3. Cross sectional Study: Prescription Opioid Misuse and Abuse Questionnaire (POMAQ) [ Time Frame: Day 1 Assessment ]
    Estimation of the prevalence of misuse, abuse, and addiction associated with long term use of opioids.

  4. Cross sectional Study: Psychiatric Research Interview for Substance and Mental Disorders, adapted for assessing addiction to opioid analgesics (PRISM5Op) [ Time Frame: Day 1 Assessment ]
    Estimation of the prevalence of misuse, abuse, and addiction associated with long term use of opioids.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Of the 2300 eligible subjects in the prospective study, 1900 will be from the HCSRN sites, 200 from the VA, and 200 from the PBRN. Sampling and recruitment strategies for the cross-sectional study will parallel those used to identify the prospective sample.
Criteria

Inclusion Criteria:

  1. Has had 30 days of new ER/LA opioid use
  2. Enrolled with medical and drug benefit for at least 12 months prior to incident use of opioids (HCSRN and VA only as enrollment is N/A to PBRNs) and 2+ visits to participating clinic during 12 months prior to incident use of opioids (PBRN, HCSRN, and VA)
  3. Additional prescription/ order for an ER/LA opioid following at least 30 days of new use
  4. Ability to complete interview/self-administered questionnaires in English
  5. Willing to provide informed consent

Exclusion Criteria:

  1. Not using an ER/LA opioid at the time of recruitment (self-report)
  2. Cognitive impairment that interferes with the ability to consent or participate in the interview, unavailable for 12 months of follow-up, or receiving hospice care as determined at the time of recruitment
  3. Diagnosis of a terminal illness in the prior 12 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751762


Contacts
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Contact: Angela DeVeaugh-Geiss, PhD angela.deveaugh-geiss@pharma.com

Locations
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United States, Oregon
Center for Health Research Recruiting
Portland, Oregon, United States, 97210
Contact: Shannon Janoff, MOH    503-335-6788    shannon.l.janoff@kpchr.org   
Sponsors and Collaborators
Member Companies of the Opioid PMR Consortium
Investigators
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Study Chair: Angela DeVeaugh-Geiss, PhD Purdue Pharma LP

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Responsible Party: Member Companies of the Opioid PMR Consortium
ClinicalTrials.gov Identifier: NCT02751762     History of Changes
Other Study ID Numbers: Observational Study 2065-1A
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
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Chronic Pain
Substance-Related Disorders
Opioid-Related Disorders
Behavior, Addictive
Pain
Neurologic Manifestations
Signs and Symptoms
Compulsive Behavior
Impulsive Behavior
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Analgesics
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents