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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 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.

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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.

Interventions

  • BEHAVIORAL TBI - Cohort 1
  • BEHAVIORAL TBI - Cohort 2

Study Locations (1)

Michigan

  • University of Michigan Health System Emergency Department - Ann Arbor

Trial Details

FieldValue
Enrollment Target 204 participants
Start Date 2013-04
Est. Completion 2015-01
Phase NA

Sponsor

University of Michigan

1,327 total trials

What the Registry Record Tells You About NCT01894087

The ClinicalTrials.gov registry entry for NCT01894087 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 204 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 343-participant average among 47 other Opioid-Related Disorders trials with a reported enrollment target (41% lower). The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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