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NCT02152397 · ClinicalTrials.gov registry record · NA
Safety and Health Intervention Project
A NA study, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 139
- Enrollment target
NCT02152397 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 139 participants.
The verdict
NCT02152397, a NA study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 139 participants
- Enrollment target
Study Summary
Use of opioid medications for treatment of pain has increased greatly in the U.S., with the average quantity of prescribed opioids increasing 700% in a decade, from \~100 morphine milligram equivalents (MME) per person to \~700 MME per person from 1997 to 2007. There have been concurrent increases in opioid-related adverse outcomes, such as extramedical use, opioid use disorders, and overdose. As a result, there were more unintentional poisoning deaths than deaths due to motor vehicle crashes among adults in 2010 (32,723 vs. 32,640). Additionally, the number of Americans seeking treatment for opioid use disorders has increased; in SAMHSA's Treatment Episode Data Set, prescription opioids were the primary substance of abuse for 142,782 individuals in 2009, compared to 22,637 in 1999, a 530% increase. The specific aims of this project are to: (1) Refine a motivational enhancement prevention intervention for prescription opioid overdose risk reduction and improved witnessed overdose response for at-risk patients in addictions treatment; (2) Conduct a pilot randomized controlled trial comparing the prescription opioid overdose prevention intervention to a supportive educational control condition for patients in addictions treatment in order to: (a) obtain information about the feasibility of randomized controlled procedures; and (b) determine the distribution and variability of the primary (overdose risk behaviors) and mediating/secondary (witnessed overdose response, self-efficacy to reduce overdose risk, knowledge of overdose risk factors and symptom recognition) outcomes; and (3) Determine the distribution and variability in changes in HIV risk behaviors (e.g., reductions in injection of prescription opioids) over follow-up.
Interventions
- BEHAVIORAL Therapist-led brief intervention (TBI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 139 participants |
| Start Date | 2014-10 |
| Est. Completion | 2016-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02152397
The ClinicalTrials.gov registry entry for NCT02152397 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 139 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Therapist-led brief intervention (TBI) is the first listed.
NCT02152397 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02152397 about?
NCT02152397 is a clinical study titled "Safety and Health Intervention Project". Use of opioid medications for treatment of pain has increased greatly in the U.S., with the average quantity of prescribed opioids increasing 700% in a decade, from \~100 morphine milligram equivalents (MME) per person to \~700 MME per person from 1997 to 2007. There have been concurrent increases i...
What is the current status of trial NCT02152397?
This trial is currently completed. It is a NA study. The enrollment target is 139 participants. The study started on 2014-10. Estimated completion is 2016-12.
What interventions are being tested in trial NCT02152397?
The interventions under investigation include: Therapist-led brief intervention (TBI) (BEHAVIORAL).
Who is sponsoring clinical trial NCT02152397?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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