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NCT03908437 · ClinicalTrials.gov registry record · Phase 4
Rapid Initiation of Drug Treatment Engagement
A Phase 4 study of Opioid Use Disorder and Overdose, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 4
- Development phase
- 104
- Enrollment target
- 1
- Study location
NCT03908437 is a Phase 4 study of Opioid Use Disorder and Overdose that has completed, run by University of Pennsylvania. The registered enrollment target is 104 participants, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03908437, a Phase 4 study of Opioid Use Disorder and Overdose, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 104 participants
- Enrollment target
- 1
- Study location
Study Summary
The proposed research will evaluate the ability of a mobile, rapid induction procedure to engage individuals in ongoing medication assisted treatment. A total of 250 untreated individuals meeting criteria for opioid use disorder and at high risk of opioid overdose will be enrolled in the study. Recruitment will take place in two targeted neighborhoods of Philadelphia (Kensington and South Philadelphia) with a high prevalence of fatal and non-fatal opioid overdose. A total of 250 participants will be engaged in the research. Following informed consent and determination of eligibility, 125 individuals will be enrolled as they engage with the mobile, rapid induction team and 125 individuals will be enrolled as they seek treatment from the CRC Episcopal Hospital (serving Kensington area) or BAC/CRC Hall Mercer Community Mental Health (serving South Philadelphia). The intervention group will receive four weeks of treatment with buprenorphine /naloxone and support for treatment engagement provided by a case manager and a peer recovery specialist. All participants will be assessed at baseline and then 1- and 6-month following enrollment. The primary endpoint for the study is continued enrollment in medication-assisted treatment at 6-month post-enrollment. The proposed research will evaluate the ability of a mobile, rapid induction procedure to engage individuals in ongoing medication assisted treatment. The specific aims are: * Aim 1: To evaluate the impact of the mobile, transitional MAT intervention on its ability to engage participants in targeted, existing MAT treatment slots at 1- and 6-month post-enrollment. * Aim 2: To evaluate the impact of the mobile intervention on subsequent drug use and overdoses at 6-month post-enrollment. * Aim 3: To assess the acceptability and costs of the intervention. The program and patient costs of delivering and participating in the intervention will be documented.
Conditions Studied
Interventions
- DRUG buprenorphine/naloxone
Study Locations (1)
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2019-07-15 |
| Est. Completion | 2023-06-30 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03908437
The ClinicalTrials.gov registry entry for NCT03908437 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (98% lower). The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Opioid Use Disorder appearing as the primary indexed condition, and to 1 intervention - of which buprenorphine/naloxone is the first listed.
NCT03908437 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03908437 about?
NCT03908437 is a clinical study titled "Rapid Initiation of Drug Treatment Engagement". The proposed research will evaluate the ability of a mobile, rapid induction procedure to engage individuals in ongoing medication assisted treatment. A total of 250 untreated individuals meeting criteria for opioid use disorder and at high risk of opioid overdose will be enrolled in the study. Recr...
What is the current status of trial NCT03908437?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 104 participants. The study started on 2019-07-15. Estimated completion is 2023-06-30.
What conditions does trial NCT03908437 study?
This clinical trial studies the following conditions: Opioid Use Disorder, Overdose.
What interventions are being tested in trial NCT03908437?
The interventions under investigation include: buprenorphine/naloxone (DRUG).
Who is sponsoring clinical trial NCT03908437?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03908437 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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