Skip to main content
Clinical Trials/NCT01894087
NCT01894087
Completed
Not Applicable

A Brief Prescription Opioid Overdose Intervention in an Emergency Department

University of Michigan1 site in 1 country204 target enrollmentApril 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Drug Overdose
Sponsor
University of Michigan
Enrollment
204
Locations
1
Primary Endpoint
Overdose Risk Behavior
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2013
End Date
January 2015
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amy S.B. Bohnert

Assistant Professor

University of Michigan

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

Outcomes

Primary Outcomes

Overdose Risk Behavior

Time Frame: 6 months post-baseline

This scale is a total sum of 9 items assessing participant's self-report of engaging in behavior that increases risk for overdose. Higher scores indicate greater risk for overdose. The range for this measure is 0 to 28 in one assessment. Results reported here as group means are for the change in sum score between baseline and follow-up, which had a possible range of -28 to 28, with lower values indicating greater decreases in overdose risk behavior.

Overdose Knowledge

Time Frame: 6 months post-baseline

Overdose symptom knowledge was assessed using an inventory of 5 true symptoms and 2 false symptoms of overdose, and the total score created as the sum of correct answers, with a range of 0 to 7. Due to the skewed distribution, this total score was standardized by subtracting the observed responses from the overall sample mean, and then dividing by the standard deviation. This resulted in a range of -5.4 to 2.6 in this sample at the 6 month follow-up, with higher numbers indicating greater overdose symptom knowledge. Also reported here are change scores generated by subtracting the standardized sum score at 6 months from the baseline standardized sum score, which had a range of -3.0 to 6.4 in this sample. Thus, higher numbers in this "change" variable indicated greater improvements in overdose symptom knowledge. Negative numbers would represent a decrease in symptom knowledge.

Behavioral Intentions

Time Frame: 6 months post-baseline

Behavioral intentions were assessed with three items that measured participant's intention to use overdose risk reduction strategies. The three strategies were (1) using opioids as prescribed, (2) reducing or avoiding use of alcohol, drugs, or non-prescribed medications, and (3) avoiding combining substances. Each item was assessed on a scale of 1 to 10, with higher numbers indicating greater intention to avoid overdose risk.

Secondary Outcomes

  • Substance Use - Current Opioid Misuse Measure(6 months post-baseline)

Study Sites (1)

Loading locations...

Similar Trials