N/A
N=204
Safety & Prevention Outcomes Study
Drug Overdose · Opioid-Related Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01894087 ↗Enrolled (actual)
204
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: Overdose Risk Behavior — -1.54; -0.51 Scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TBI - Cohort 1 (Behavioral); TBI - Cohort 2 (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overdose Risk Behavior |
-1.54; -0.51 | — |
| PRIMARY Overdose Knowledge |
0.12; -0.11 | — |
| PRIMARY Behavioral Intentions |
8.0; 8.4; 8.1; 7.0; 8.7; 8.6 | — |
| SECONDARY Substance Use - Current Opioid Misuse Measure |
-4.44; -3.54 | — |
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
Data sourced from ClinicalTrials.gov (NCT01894087). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.