CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 204 enrolled
Drug / intervention
TBI - Cohort 1 +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01894087
NCT01894087N/ACompleted

A Brief Prescription Opioid Overdose Intervention in an Emergency Department

University of Michigan·interventional·Posted Jul 9, 2013·Updated Jan 19, 2018

In Brief

A clinical study evaluating TBI - Cohort 1 and TBI - Cohort 2 for Drug Overdose and Opioid-Related Disorders. Completed, enrolled 204 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 9, 2013
Enrollment StartApr 1, 2013
Primary CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.0 years ago

Interventions

TBI - Cohort 1behavioral

TBI - Cohort 2behavioral