Safety & Prevention Outcomes Study
Completed · Not applicable
Conditions studied: Drug Overdose, Opioid-Related Disorders
In brief
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.
Key facts
- Study ID
- NCT01894087
- Run by
- University of Michigan
- People needed
- 204
- Starts
- 2013-04-01
- Expected to finish
- 2015-01-01
- Last updated by the study team
- 2018-01-19
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- patients 18-60 presenting to the ED for medical care
- ability to provide informed consent
- Additional criteria for intervention: past extramedical opioid use
You may not qualify if…
- patients who do not understand English
- prisoners
- patients classified by medical staff as a "Level 1" trauma (e.g., in need of immediate lifesaving procedures)
- patients deemed unable to provide informed consent
- patients treated in the ED for suicide attempt or sexual assault
Where it is running
- University of Michigan Health System Emergency Department — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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