Clinical Trials Directory

Trials / Completed

CompletedNCT02152397

Safety and Health Intervention Project

Developing a Prescription Opioid Overdose Prevention Intervention in Addictions Treatment

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

Summary

Use of opioid medications for treatment of pain has increased greatly in the U.S., with the average quantity of prescribed opioids increasing 700% in a decade, from \~100 morphine milligram equivalents (MME) per person to \~700 MME per person from 1997 to 2007. There have been concurrent increases in opioid-related adverse outcomes, such as extramedical use, opioid use disorders, and overdose. As a result, there were more unintentional poisoning deaths than deaths due to motor vehicle crashes among adults in 2010 (32,723 vs. 32,640). Additionally, the number of Americans seeking treatment for opioid use disorders has increased; in SAMHSA's Treatment Episode Data Set, prescription opioids were the primary substance of abuse for 142,782 individuals in 2009, compared to 22,637 in 1999, a 530% increase. The specific aims of this project are to: (1) Refine a motivational enhancement prevention intervention for prescription opioid overdose risk reduction and improved witnessed overdose response for at-risk patients in addictions treatment; (2) Conduct a pilot randomized controlled trial comparing the prescription opioid overdose prevention intervention to a supportive educational control condition for patients in addictions treatment in order to: (a) obtain information about the feasibility of randomized controlled procedures; and (b) determine the distribution and variability of the primary (overdose risk behaviors) and mediating/secondary (witnessed overdose response, self-efficacy to reduce overdose risk, knowledge of overdose risk factors and symptom recognition) outcomes; and (3) Determine the distribution and variability in changes in HIV risk behaviors (e.g., reductions in injection of prescription opioids) over follow-up.

Conditions

Interventions

TypeNameDescription
BEHAVIORALTherapist-led brief intervention (TBI)

Timeline

Start date
2014-10-01
Primary completion
2016-12-01
Completion
2016-12-01
First posted
2014-06-02
Last updated
2017-04-17

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02152397. Inclusion in this directory is not an endorsement.