Safety and Health Intervention Project

Completed · Not applicable

Conditions studied: Drug Overdose, Opioid Related Disorders

In brief

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.

Key facts

Study ID

NCT02152397

Run by

University of Michigan

People needed

139

Starts

2014-10-01

Expected to finish

2016-12-01

Last updated by the study team

2017-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients 18 and older in treatment at CPI
• able to provide informed consent.

You may not qualify if…

• acute suicidality
• psychiatric condition that precludes participation in the intervention
• inability to speak and understand English
• inability to give informed, voluntary, written consent for any reason

Where it is running

• Community Programs, Inc. — Waterford, Michigan, United States

Full record on ClinicalTrials.gov

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