Clinical Trials Directory

Trials / Completed

CompletedNCT01894087

Safety & Prevention Outcomes Study

A Brief Prescription Opioid Overdose Intervention in an Emergency Department

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
204 (actual)
Sponsor
University of Michigan · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

Summary

Unintentional poisoning is a developing public health problem in the U.S. Unintentional poisoning (or "overdose") deaths increased 157% among adults between 1999 and 2008. There were \~700,000 emergency department (ED) visits due to overdoses in 2007. Medication-related overdoses, particularly prescription opioid overdoses, have accounted for much of this increase. There have been parallel increases in sales of opioids (with a 6 fold increase between 1997 and 2007), as well as both medical and non-medical use of prescription opioids. Prescription opioids are now among the most common of drugs used non-medically in the U.S. The specific aims of this project are to: 1) Develop an ED-based tailored brief prescription opioid overdose prevention intervention. We will examine therapeutic alliance, perceived satisfaction, and perceived utility of the intervention; 2) Examine intervention effects on precursors of overdose risk behavioral change immediately post-intervention. We will compare intervention and control participants on knowledge, self-efficacy, readiness to change, and behavioral intentions regarding overdose risk behavior; and 3) Examine intervention effects on overdose risk behaviors six months post-intervention. We will compare intervention and control participants on: 1) use of high dose/quantity of opioids; 2) using opioids in combinations with certain psychoactive substances (i.e., alcohol, heroin, cocaine, and sedatives); and, 3) route of administration.

Conditions

Interventions

TypeNameDescription
BEHAVIORALTBI - Cohort 1
BEHAVIORALTBI - Cohort 2

Timeline

Start date
2013-04-01
Primary completion
2015-01-01
Completion
2015-01-01
First posted
2013-07-09
Last updated
2018-01-19
Results posted
2018-01-19

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01894087. Inclusion in this directory is not an endorsement.