Conducting clinical research with prescription opioid dependence: Defining the population.

Most treatment studies of opioid-dependent populations have focused predominantly on heroin users, despite a recent increase in those dependent upon prescription opioids. A key methodological challenge involved in studying the latter group involves defining the population. Specifically, researchers must decide whether to include 1) concurrent heroin users and 2) individuals with pain. The multi-site Prescription Opioid Addiction Treatment Study in the National Drug Abuse Treatment Clinical Trials Network (protocol CTN-0030) is examining treatments for this population.

This paper describes various inclusion criteria considered by the study team related to heroin use and pain. The goal was to recruit a distinct but generalizable population of individuals dependent upon prescription opioids. The recruitment methods used in the POATS study have demonstrated face validity and may be replicated in future studies seeking a distinct but generalizable subset of persons dependent upon prescription opioids. This would aid in cross-study comparisons of outcomes, as well as eventually developing successful evidence-based treatment approaches for these patients.

Related protocols: CTN-0030