The National Opioid Medication ABuse Deterrence (NOMAD) study
A new oxycodone formulation (Reformulated OxyContin®) was released in Australia, early 2014. It was developed as a tamper-resistant (“abuse-deterrent”) formulation of the drug.
The National Opioid Medication Abuse Deterrence (NOMAD) study, will examine: 1) whether there is a reduction in extra-medical use (including via tampering) of OxyContin® following the introduction of Reformulated OxyContin®; 2) potential changes in extra-medical use of non-abuse-deterrent forms of oxycodone, other pharmaceutical opioids, and illicit drugs; 3) whether methods of tampering with Reformulated OxyContin® become widespread over time; 4) Reformulated OxyContin®’s attractiveness on the illicit market; 5) sales, prescriptions and harms related to OxyContin® and other drugs.
There are three major components. First, analyses of existing routine data sources such as: pharmaceutical sales; prescribing data; data on drug overdose deaths; survey data on drug use in the general population and among people who inject drugs. Second, specific data on OxyContin® collected through Illicit Drug Reporting System. Third, a prospective cohort of n=606 people who regularly misuse or tamper with pharmaceutical opioids was formed prior to the introduction of Reformulated OxyContin®, followed up twice post-release to examine potential changes after Reformulated OxyContin®’s introduction.
Discussion: The study’s strengths lie in varied data collections; interrupted time series analysis; and prospective cohort. To our knowledge, this is one of the most comprehensive and transparently-conducted studies conducted to-date of the potential impact of an opioid medication upon use, tampering and diversion. Results have the potential to inform policymakers, clinicians, consumers and researchers alike.