Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study, sponsored by University of Michigan.
NCT02152397 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 139 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Overdose risk behavior will be measured for change over time using the Current Opioid Misuse Measure (COMM), Overdose Experience, Self and Witnessed (OESW), Overdose Risk Behavior (ORB) and Timeline Follow-Back (TLFB). The COMM is an 8 item scale assessing prescription pain medication use in the past months. It has a good test-retest reliability and an α=.93 in our prior studies. The OESW is an 11 item scale assessing experiences with overdoses in the past months (self and witnessed) which are r
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 |
What the finished NCT02152397 record still lists
NCT02152397 is an interventional study that assigns participants to a tested intervention. The registered 139 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which Therapist-led brief intervention (TBI) is the first listed.
NCT02152397 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02152397's enrollment target sits among peer trials
139 720th of 2000 higher than 1,281 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05645380 · 139 participants · Phase 2
Neoadjuvant TIL- and Response-Adapted Chemoimmunotherapy for TNBC
- NCT06239272 · 139 participants · Phase 1
NRSTS2021, A Risk Adapted Study Evaluating Maintenance Pazopanib, Limited Margin, Dose-Escalated Radiation Therapy and Selinexor in Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)
- NCT06252220 · 139 participants · Phase 1
First in Human Study in Subjects With Obesity, But Otherwise Healthy
- NCT06537128 · 139 participants · NA
Internet-delivered Cognitive-Behavioral Therapy for Adolescents With Autism and Anxiety
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia