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NCT06130501 · ClinicalTrials.gov registry record · NA
tAN for PTSD and OUD in Buprenorphine Therapy
A NA study of Post Traumatic Stress Disorder and Opioid Use Disorder, sponsored by University of Cincinnati.
- Active
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06130501: Active NA study of Post Traumatic Stress Disorder and Opioid Use Disorder, sponsored by University of Cincinnati.
NCT06130501 is a NA study of Post Traumatic Stress Disorder and Opioid Use Disorder that is active but no longer recruiting, run by University of Cincinnati. The registered enrollment target is 20 participants, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06130501, a NA study of Post Traumatic Stress Disorder and Opioid Use 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
Primary Outcome
3-month BUP retention, operationalized as a current BUP prescription at the time of data extraction (retained/not retained), will be examined by observing the proportion of participants who are retained in BUP therapy at 3 months post-randomization.
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 |
What the registry record for NCT06130501 still lists
NCT06130501 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 2 interventions - of which Sparrow Ascent tAN is the first listed.
NCT06130501 reports a single indexed study location in 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: Post Traumatic Stress Disorder, Opioid Use 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.
Learn More About Clinical Trials
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Where NCT06130501's enrollment target sits among peer trials
20 231st of 262 higher than 22 of 262 other Post Traumatic Stress Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Post Traumatic Stress 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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