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NCT01894087 · ClinicalTrials.gov registry record · NA
Safety & Prevention Outcomes Study
A NA study of Opioid-Related Disorders and Drug Overdose, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 204
- Enrollment target
- 1
- Study location
NCT01894087: Completed NA study of Opioid-Related Disorders and Drug Overdose, sponsored by University of Michigan.
NCT01894087 is a NA study of Opioid-Related Disorders and Drug Overdose that has completed, run by University of Michigan. The registered enrollment target is 204 participants, below the 343-participant average among 47 other Opioid-Related Disorders trials with a reported enrollment target (41% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01894087, a NA study of Opioid-Related Disorders and Drug Overdose, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 204 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- BEHAVIORAL TBI - Cohort 1
- BEHAVIORAL TBI - Cohort 2
Study Locations (1)
Michigan
- University of Michigan Health System Emergency Department - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 204 participants |
| Start Date | 2013-04 |
| Est. Completion | 2015-01 |
| Phase | NA |
What the finished NCT01894087 record still lists
NCT01894087 is an interventional study that assigns participants to a tested intervention. The registered 204 participants enrollment target is mid-sized for trials with a published cap, below the 343-participant average among 47 other Opioid-Related Disorders trials with a reported enrollment target (41% lower).
The record links to 2 conditions, with Opioid-Related Disorders appearing as the primary indexed condition, and to 2 interventions - of which TBI - Cohort 1 is the first listed.
NCT01894087 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT01894087 about?
NCT01894087 is a clinical study titled "Safety & Prevention Outcomes Study". 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 presc...
What is the current status of trial NCT01894087?
This trial is currently completed. It is a NA study. The enrollment target is 204 participants. The study started on 2013-04. Estimated completion is 2015-01.
What conditions does trial NCT01894087 study?
This clinical trial studies the following conditions: Opioid-Related Disorders, Drug Overdose.
What interventions are being tested in trial NCT01894087?
The interventions under investigation include: TBI - Cohort 1 (BEHAVIORAL), TBI - Cohort 2 (BEHAVIORAL).
Who is sponsoring clinical trial NCT01894087?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01894087 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01894087's enrollment target sits among peer trials
204 19th of 47 higher than 29 of 47 other Opioid-Related Disorders trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid-Related Disorders trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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