Incidence of opioid use disorder among patients prescribed long-term opioid therapy: An observational study

There are no estimates of incident opioid use disorder (OUD), using current diagnostic criteria, among patients prescribed long-term opioid therapy (LtOT). The U.S. Food and Drug Administration issued a postmarketing requirement to estimate the 12-month incidence of OUD among patients receiving LtOT.

Study 3033-1 was a prospective, observational cohort study conducted in 10 health systems with one year of follow up. Data were collected August 2017 to October 2021, analyses were completed December 2025. The primary outcome was pain-adjusted, moderate to severe DSM-5 OUD involving prescription opioids measured using the Psychiatric Research Interview for Substance and Mental Disorders, adapted for assessing OUD among patients treated with opioids (PRISM-5-OP). Secondary outcomes included moderate to severe DSM-5 OUD without pain adjustment and any OUD involving prescription opioids with and without pain adjustment. Overall and stratified incidence were calculated.

1952 participants were included; 76% were aged 50 + ; 58% were female, 80% were White. The 12-month incidence of the primary outcome was 1.54%, the outcome without pain adjustment resulted in an incidence of 4.46%. Incidence of any DSM-5 OUD involving prescription opioids was 6.92% with pain adjustment and 18.14% without pain adjustment. Incidence estimates were similar across age, sex, and Medicaid status. Some estimates were higher among those with past-year or prior to past-year substance use or major depressive disorders.

At one year, the incidence of at least moderate OUD ranged from 1.54% to 4.46%. These findings can inform clinician and patient shared decision-making and evaluations of OUD prevention efforts.

NCT02751762.