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NCT06130501 · ClinicalTrials.gov registry record · NA
tAN for PTSD and OUD in Buprenorphine Therapy
A NA study of Opioid Use Disorder and Posttraumatic Stress Disorder, sponsored by University of Cincinnati.
- Active
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06130501 is a NA study of Opioid Use Disorder and Posttraumatic Stress Disorder that is active but no longer recruiting, run by University of Cincinnati. The registered enrollment target is 20 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.
The verdict
NCT06130501, a NA study of Opioid Use Disorder and Posttraumatic Stress Disorder, is active but no longer recruiting, sponsored by University of Cincinnati.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this research study supported by the HEAL Initiative (https://heal.nih.gov) is to investigate the effects transcutaneous auricular neurostimulation (tAN), as delivered through the Sparrow Ascent device, on helping people with co-occurring posttraumatic stress disorder (PTSD) and opioid use disorder (OUD) start and continue buprenorphine treatment. The main questions it aims to answer are: * Does the tAN help participants with OUD and PTSD remain in buprenorphine therapy for three months after starting use of the device (i.e., randomization to treatment condition)? * Do participants find the Sparrow Ascent device to be acceptable and use it? * Do participants find the Sparrow Ascent device to be tolerable and comfortable to use? * Do participants find the Sparrow Ascent device to be easy to use with their buprenorphine therapy? * Do participants follow the minimum recommended dose schedule for the Sparrow Ascent device most of the time? Participants will complete a baseline assessment to make sure that they are eligible to participate in the study. The assessment captures information about demographics, substance use and treatment history, opioid withdrawal symptoms and craving, difficult life experiences and PTSD symptoms, mental health and treatment history, quality of life, and recovery resources. After the assessment is complete and the participant has been inducted on buprenorphine as part of standard care, they are randomized to one of two treatment conditions: active tAN and placebo. Participants are trained on how to use the device and return for 12 weekly research visits to check on recent substance use and craving, PTSD symptoms, and their experience using the device. After 12 weeks of using the device, participants will complete a post-active treatment assessment that is nearly identical to the baseline assessment to see if there have been changes in these areas. Researchers will access the medical record to determine whether there is a curre
Conditions Studied
Interventions
- DEVICE Sparrow Ascent tAN
- DEVICE Sparrow Ascent Active Sham
Study Locations (1)
Missouri
- Gibson Center for Behavioral Change - Cape Girardeau
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-07-01 |
| Est. Completion | 2026-06-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06130501
The ClinicalTrials.gov registry entry for NCT06130501 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 20 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 (100% lower). The listed sponsor is University of Cincinnati, which has 245 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 2 interventions - of which Sparrow Ascent tAN is the first listed.
NCT06130501 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT06130501 about?
NCT06130501 is a clinical study titled "tAN for PTSD and OUD in Buprenorphine Therapy". The goal of this research study supported by the HEAL Initiative (https://heal.nih.gov) is to investigate the effects transcutaneous auricular neurostimulation (tAN), as delivered through the Sparrow Ascent device, on helping people with co-occurring posttraumatic stress disorder (PTSD) and opioid u...
What is the current status of trial NCT06130501?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2024-07-01. Estimated completion is 2026-06-30.
What conditions does trial NCT06130501 study?
This clinical trial studies the following conditions: Opioid Use Disorder, Posttraumatic Stress Disorder.
What interventions are being tested in trial NCT06130501?
The interventions under investigation include: Sparrow Ascent tAN (DEVICE), Sparrow Ascent Active Sham (DEVICE).
Who is sponsoring clinical trial NCT06130501?
This trial is sponsored by University of Cincinnati, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06130501 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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