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

NCT02751762 | Completed

• 2 other identifiers: Observational Study 3033-1Study 3033-1
• Study Type: observational
• Target: 3,600
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to quantify the serious risks of prescription opioid misuse or abuse or opioid use disorder (OUD) associated with the long term use of opioid analgesics for management of chronic pain, among patients prescribed opioid products.

Conditions

Opioid-Related Disorders; Opiate Addiction; Narcotic Abuse; Drug Abuse

Outcome Measures

Primary Outcomes (4)

• Prospective Longitudinal study: Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)

  Estimation of the incidence of misuse and abuse associated with long-term use of opioids for chronic pain.

  Change from baseline at up to one year

• Prospective Longitudinal study: Psychiatric Research Interview for Substance and Mental Disorders, adapted for assessing addiction to opioid analgesics (PRISM-5-OP)

  Estimation of the incidence of addiction associated with long-term use of opioids for chronic pain.

  Change from baseline at one year

• Cross sectional Study: Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)

  Estimation of the prevalence of misuse and abuse associated with long term use of opioids for chronic pain.

  Day 1 Assessment

• Cross sectional Study: Psychiatric Research Interview for Substance and Mental Disorders, adapted for assessing addiction to opioid analgesics (PRISM-5-OP)

  Estimation of the prevalence of addiction associated with long term use of opioids for chronic pain.

  Day 1 Assessment

Study Arms (2)

Prospective Longitudinal Cohort

Patients who have recently initiated long-term opioid therapy or initiated ER/LA opioid therapy

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

Other: Observation Only

Interventions

Observation Only OTHER

No Intervention

Cross-sectional Cohort; Prospective Longitudinal Cohort

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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
• 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)

Sponsors & Collaborators

• Member Companies of the Opioid PMR Consortium: lead
• Kaiser Permanente: collaborator

Study Sites (2)

Kaiser Permanente Northwest

Portland, Oregon, 97210, United States

Location

Kaiser Permanente Washington

Seattle, Washington, 98112, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva samples collected from consented study participants

MeSH Terms

Conditions

Opioid-Related Disorders; Narcotic-Related Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Kenneth R Petronis

  Epi Ideas LLC

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: April 26, 2016
• Study Start: November 1, 2017
• Primary Completion: October 1, 2021
• Study Completion: January 31, 2023
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

US (2)