Clinical trial NCT01894087: Safety & Prevention Outcomes Study
Official title: A Brief Prescription Opioid Overdose Intervention in an Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Overdose
Opioid-Related Disorders
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2013-07-09
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

* patients 18-60 presenting to the ED for medical care
* ability to provide informed consent
* Additional criteria for intervention: past extramedical opioid use

Exclusion Criteria:

* 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

Primary outcomes:
measure: Overdose Risk Behavior
timeFrame: 6 months post-baseline
measure: Overdose Knowledge
timeFrame: 6 months post-baseline
measure: Behavioral Intentions
timeFrame: 6 months post-baseline
Secondary outcomes:
measure: Substance Use - Current Opioid Misuse Measure
timeFrame: 6 months post-baseline
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System Emergency Department
state: Michigan
Study officials:
affiliation: University of Michigan
name: Amy Bohnert, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bohnert AS, Bonar EE, Cunningham R, Greenwald MK, Thomas L, Chermack S, Blow FC, Walton M. A pilot randomized clinical trial of an intervention to reduce overdose risk behaviors among emergency department patients at risk for prescription opioid overdose. Drug Alcohol Depend. 2016 Jun 1;163:40-7. doi: 10.1016/j.drugalcdep.2016.03.018. Epub 2016 Mar 26.