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NCT03526380 · ClinicalTrials.gov registry record · NA
The OPT-IN Project
A NA study, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 92
- Enrollment target
NCT03526380: Completed NA study, sponsored by University of Michigan.
NCT03526380 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 92 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03526380, a NA study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 92 participants
- Enrollment target
Study Summary
Prescription opioid overdose represents a public health crisis. A number of efforts have been implemented to address opioid prescribing and opioid risk mitigation strategies for prescribers, but relatively few efforts have sought to address this problem directly with individuals who use opioids. This gap likely fails to fully address the inherent reinforcing nature of the medications that make it challenging to reduce use. The specific aim of this study is to pilot test a toolkit that pairs an intervention with the distribution of naloxone. External facilitation (supervision check-ins) will aid translation to delivery by non-research staff. Firstly, data will be collected from participants over time as a control group, prior to training site staff. Next, non-research staff will be trained on the intervention. Staff at the site will use the online "toolkit" developed in the beginning of this project to deliver the interventions and naloxone to their clients/patients as part of usual care. After staff at the site(s) are trained, additional data will be collected from participants during the intervention period and after 3-months.
Primary Outcome
The ORB measures change over time for prescription opioid use, specific to type of opioid use, combination with other substances, route, and if they use alone. 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 32 in one assessment.
Interventions
- BEHAVIORAL Behavioral: the OPT-IN Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2018-10-11 |
| Est. Completion | 2020-06-30 |
| Phase | NA |
What the finished NCT03526380 record still lists
NCT03526380 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Behavioral: the OPT-IN Intervention is the first listed.
NCT03526380 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03526380 about?
NCT03526380 is a clinical study titled "The OPT-IN Project". Prescription opioid overdose represents a public health crisis. A number of efforts have been implemented to address opioid prescribing and opioid risk mitigation strategies for prescribers, but relatively few efforts have sought to address this problem directly with individuals who use opioids. Thi...
What is the current status of trial NCT03526380?
This trial is currently completed. It is a NA study. The enrollment target is 92 participants. The study started on 2018-10-11. Estimated completion is 2020-06-30.
What interventions are being tested in trial NCT03526380?
The interventions under investigation include: Behavioral: the OPT-IN Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT03526380?
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 NCT03526380's enrollment target sits among peer trials
92 937th of 2000 higher than 1,062 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
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