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NCT03769025 · ClinicalTrials.gov registry record · Phase 1
Remote Observed Dosing of Suboxone to Improve Clinical Practice
A Phase 1 study of Opioid Use Disorder and Opioid Dependence, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT03769025: Completed Phase 1 study of Opioid Use Disorder and Opioid Dependence, sponsored by University of Pennsylvania.
NCT03769025 is a Phase 1 study of Opioid Use Disorder and Opioid Dependence that has completed, run by University of Pennsylvania. The registered enrollment target is 16 participants, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03769025, a Phase 1 study of Opioid Use Disorder and Opioid Dependence, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a 15-week, outpatient study of remote observed dosing to improve suboxone compliance in opiate dependent subjects.The main purpose of this study is to see if watching patients take their medication will improve treatment of opiate dependence by prompting patients to take all prescribed doses of Suboxone. Suboxone is approved by the Food and Drug Administration (FDA) for the treatment of opiate dependence. All patients receive a smartphone and patients in the intervention (remote observed dosing) group will use the smartphone to take videos of themselves taking Suboxone.
Primary Outcome
compare the mean urinary buprenorphine level obtained over 12 weeks between the two groups
Conditions Studied
Interventions
- BEHAVIORAL Suboxone Remote Observed Dosing
- OTHER Suboxone Attention Control
Study Locations (1)
Pennsylvania
- University of Pennsylvania Treatment Research Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2019-04-01 |
| Est. Completion | 2022-07-01 |
| Phase | Phase 1 |
What the finished NCT03769025 record still lists
NCT03769025 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with Opioid Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Suboxone Remote Observed Dosing is the first listed.
NCT03769025 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03769025 about?
NCT03769025 is a clinical study titled "Remote Observed Dosing of Suboxone to Improve Clinical Practice". This is a 15-week, outpatient study of remote observed dosing to improve suboxone compliance in opiate dependent subjects.The main purpose of this study is to see if watching patients take their medication will improve treatment of opiate dependence by prompting patients to take all prescribed doses...
What is the current status of trial NCT03769025?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2019-04-01. Estimated completion is 2022-07-01.
What conditions does trial NCT03769025 study?
This clinical trial studies the following conditions: Opioid Use Disorder, Opioid Dependence, Opiate Dependence.
What interventions are being tested in trial NCT03769025?
The interventions under investigation include: Suboxone Remote Observed Dosing (BEHAVIORAL), Suboxone Attention Control (OTHER).
Who is sponsoring clinical trial NCT03769025?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03769025 being conducted?
This trial has 1 study location across Pennsylvania. 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 NCT03769025's enrollment target sits among peer trials
16 241st of 257 higher than 17 of 257 other Opioid Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Use Disorder 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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