Naloxone Auto-injector as a Universal Precaution for Patients With Opioid Use Disorder

Between April 4, 2016, and May 16, 2017, 395 study participants voluntarily enrolled at the UNM ASAP for this prospective cohort study. The study closed 1 year after enrollment, on May 17, 2018. These study participants were current patients of the University of New Mexico's Addiction and Substance Abuse Program.

This study was approved by the University of New Mexico Human Research and Review Committee and was registered in the National Institutes of Health Clinical Trials (ClinicalTrials.gov Identifier NCT02669901). A certificate of confidentiality is on record at the National Institutes of Health for this study. Written informed consent was obtained from each individual study participant. This study follows the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline.

Each study participant completed the initial visit and at least 1 follow-up visit. Inclusion criteria included history of OUD treated with methadone, buprenorphine, or naltrexone and age 18 years or older. Exclusion criteria included allergy to naloxone and age younger than 18 years.

The UNM ASAP is a federally qualified opioid treatment program (OTP) that provides medication-assisted treatment and behavioral therapy for adults, including pregnant women, as well as adolescents. Approximately 65% of the UNM ASAP patients are women. Most (80%) of the patients had previously used heroin (compared with prescription opioids) as their drug of choice before beginning medication-assisted treatment.

Initial Visit Data Collection At the initial visit, study participants provided demographic data, social history, limited medical history, type of medication-assisted treatment, medication list, and history of illicit drug use.21 All 395 study participants enrolled were evaluated to determine whether they had received a naloxone prescription in the year before enrollment. First, each participant's electronic medical record was queried to see whether a prescription for naloxone was written in the year before study enrollment. Second, every study participant was personally asked by the research coordinator at the initial study visit whether they had directly received a naloxone prescription in the year before enrollment.