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

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.

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