drugset / Trial / NCT01788306

Project OOPEN: Opioid Overdose Prevention, Education and Intervention

NCT01788306 ↗

RandomizedParallel-groupOpen-labelPrevention

Summary

This prospective, randomized emergency department trial will study the effectiveness of an intervention that combines opioid overdose prevention, education and intervention that includes take home naloxone with brief behavioral change counseling. The study will recruit both heroin users (n=500) and pharmaceutical opioid users at elevated risk for overdose (n=500). Outcomes of interest include subsequent opioid overdoses and overdose risk behaviors. Primary Aims The primary aims are to test whether those who receive the intervention compared to standard care have: 1) Lower rates of opioid non-fatal and fatal overdose; 2) Reduce drug use, inappropriate medication use, and other overdose risk behaviors. Secondary Aims The secondary aims are to test whether those who receive the intervention compared to standard care have: 3) More appropriate health care utilization (e.g. fewer emergency department visits and admissions to inpatient care); 4) Lower total health care costs; 5) Determine the prevalence of HIV risk behaviors among heroin and pharmaceutical opioid users at risk for overdose and whether the intervention impacts these behaviors.

Timeline

Start
2013-01
Primary completion
2018-10
Completion
2018-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator OOPEN+BBCC Unknown — —