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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

Tracking Information
First Submitted Date April 6, 2016
First Posted Date April 26, 2016
Last Update Posted Date November 30, 2017
Actual Study Start Date November 1, 2017
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 21, 2016)
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02751762 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief 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
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
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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Opioid-Related Disorders
  • Opiate Addiction
  • Narcotic Abuse
  • Drug Abuse
Intervention
  • 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
Study Groups/Cohorts
  • Prospective Longitudinal Cohort
    Patients who have recently initiated at least 30 days of ER/LA opioid therapy
    Interventions:
    • 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
  • Cross-sectional Cohort
    Patients who have been treated with opioids (including at least one ER/LA opioid) for greater than 1 year
    Interventions:
    • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 21, 2016)
2530
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Angela DeVeaugh-Geiss, PhD angela.deveaugh-geiss@pharma.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02751762
Other Study ID Numbers Observational Study 2065-1A
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Member Companies of the Opioid PMR Consortium
Study Sponsor Member Companies of the Opioid PMR Consortium
Collaborators Not Provided
Investigators
Study Chair: Angela DeVeaugh-Geiss, PhD Purdue Pharma LP
PRS Account Member Companies of the Opioid PMR Consortium
Verification Date November 2017