Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Prospective Investigation of the Risks of Opioid Misuse, Abuse, and Addiction Among Patients Treated With Opioids for the Treatment of Chronic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02751762
Recruitment Status : Recruiting
First Posted : April 26, 2016
Last Update Posted : April 15, 2020
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 April 15, 2020
Actual Study Start Date November 1, 2017
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 14, 2020)
  • 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 and abuse associated with long-term use of 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 addiction associated with long-term use of 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 and abuse associated with long term use of opioids for chronic pain.
  • 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 addiction associated with long term use of opioids for chronic pain.
Original 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.
Change History
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 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 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 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, and addiction associated with long-term use of opioid analgesics for management of chronic pain, among patients prescribed 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 opioid products. Patients will be recruited from seven Health Care System Research Network (HCSRN) sites; one U.S. Department of Veterans Affairs (VA) site; and clinics participating in two 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), 2) web-based assessments (or phone if unable to complete via web), and 3) electronic medical record and claims data. The study design includes two components: 1) a prospective longitudinal study of patients who have recently initiated long-term opioid therapy or initiated 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 at least one year.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Saliva samples collected from consented study participants
Sampling Method Non-Probability Sample
Study Population Of the approximately 2300 eligible subjects in the prospective study, approximately 2200 will be from the HCSRN sites, 25 from the VA, and a total of 100 from the PBRN sites. 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: Observation Only
No Intervention
Study Groups/Cohorts
  • Prospective Longitudinal Cohort
    Patients who have recently initiated long-term opioid therapy or initiated ER/LA opioid therapy
    Intervention: Other: Observation Only
  • Cross-sectional Cohort
    Patients who have been treated with opioids (including at least one ER/LA opioid) for greater than one year
    Intervention: Other: Observation Only
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 14, 2020)
3632
Original Estimated Enrollment
 (submitted: April 21, 2016)
2530
Estimated Study Completion Date October 2022
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Eligibility Criteria for the Prospective Study

Inclusion Criteria:

  • Initiation* of ER/LA opioid therapy that includes 28+ days of an ER/LA followed by a subsequent ER/LA prescription (ER/LA initiators) or initiation** of long-term opioid therapy (LtOT - 90+ days of use) with ER/LA and/or Schedule II IR/SA opioids (LtOT initiators).
  • Age 18-79 years at incident prescription
  • Enrolled in the health plan (HCSRN sites) or regularly receiving care in the health system (VA and PBRNs) for at least 12 months prior to incident use of opioids
  • Ability to complete interview/self-administered questionnaires in English
  • Willing and able to provide informed consent

    • Initiation or new use of ER/LA therapy defined as no ER/LA opioid use in the prior six-months ** Initiation or new LtOT use defined as no ER/LA or Schedule II IR/SA opioid use in the prior six-months

Exclusion Criteria:

  • Not using an ER/LA or Schedule II IR/SA opioid at the time of recruitment or first interview (self-report)
  • Cognitive impairment that interferes with the ability to consent or participate in the interview
  • Unavailable for 12 months of follow-up (self-report)
  • Receiving hospice care (EHR and recruitment screening)
  • Diagnosis of a terminal illness in the prior 12 months per chart review or recruitment screening
  • Existing opioid use disorder (ICD-9 and ICD-10 diagnosis codes)
  • Medication assisted treatment with methadone or buprenorphine (self-report)

Eligibility Criteria - Cross Sectional Study:

Inclusion Criteria:

  • Regular opioid use in the past year with at least 1 prescription for an ER/LA opioid. See Figure 4 for specifics on how these criteria are operationalized.
  • Age 18-79 years at index prescription Enrolled in the health plan (HCSRN sites) or regularly receiving care in the health system (VA and PBRNs) for at least 12 months prior to index date.
  • Ability to complete interview/self-administered questionnaires in English
  • Willing and able to provide informed consent

Exclusion Criteria:

  • Not using an opioid at the time of recruitment or first interview (self-report)
  • Cognitive impairment that interferes with the ability to consent or participate in the interview
  • Receiving hospice care (EHR and recruitment screening)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Kenneth Petronis 212-733-0555 Kenneth.R.Petronis@pfizer.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02751762
Other Study ID Numbers Observational Study 3033-1
Study 3033-1 ( Other Identifier: Member Companies of the Opioid PMR Consortium )
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: Kenneth Petronis Pfizer
PRS Account Member Companies of the Opioid PMR Consortium
Verification Date April 2020