Safety & Prevention Outcomes Study

Opioid-Related Disorders Clinical Trial

— SPOS  

Official title:

A Brief Prescription Opioid Overdose Intervention in an Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01894087
• Other study ID #: R49CE002099
• Status: Completed
• Phase: N/A
• First received: July 2, 2013
• Last updated: May 31, 2017
• Start date: April 2013
• Est. completion date: January 2015

Study information

• Verified date: May 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Overdose
• Opioid-Related Disorders

Intervention

Behavioral:
• TBI - Cohort 1

• TBI - Cohort 2

Locations

Country	Name	City	State
United States	University of Michigan Health System Emergency Department	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overdose Risk Behavior	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.	6 months post-baseline
Primary	Overdose Knowledge	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.	6 months post-baseline
Primary	Behavioral Intentions	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.	6 months post-baseline
Secondary	Substance Use - Current Opioid Misuse Measure	This measure contained 8 items from the Current Opioid Misuse Measure. Items were assessed on a scale of "never (0)," "rarely (1)," "sometimes (3)," "often (4)," and "very often (5)." A sum score took a range of 0 to 40, with higher numbers indicating more non-medical opioid use. For group means reported here, change scores were calculated by subtracting the baseline level of this measure from the level at 6 months follow-up. This change score has a possible range of -40 to 40, with lower values indicating greater decreases in non-medical opioid use.	6 months post-baseline