Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06130501
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-10-26
Brief Title:
tAN for PTSD and OUD in Buprenorphine Therapy
Sponsor:
University of Cincinnati
Organization:
University of Cincinnati
Study Overview
Official Title:
IMBUE RETAIN Transcutaneous Auricular Neurostimulation tAN for Patients With Co-occurring Posttraumatic Stress Disorder PTSD and Opioid Use Disorder Starting Buprenorphine Therapy
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this research study supported by the HEAL Initiative httpshealnihgov 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 ie 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 in the clinic 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 current prescription for buprenorphine at three months and six months after randomization
Does the tAN help participants with OUD and PTSD remain in buprenorphine therapy for three months after starting use of the device ie 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 in the clinic 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 current prescription for buprenorphine at three months and six months after randomization
Detailed Description:
Supported by the HEAL Initiative httpshealnihgov the overall UG3UH3 phased project will test transcutaneous auricular neurostimulation tAN to the trigeminal and vagus nerves via the Sparrow Ascent device as an adjunct intervention to improve retention in buprenorphine treatment BUP for patients with co-occurring opioid use disorder and posttraumatic stress disorder The specific objectives of the UG3 project are to
1 conduct a pilot randomized active sham-controlled test of transcutaneous auricular neurostimulation tAN with the Sparrow Ascent device to determine its acceptability tolerability feasibility and adherence in patients with OUD and PTSD starting buprenorphine BUP therapy
2 submit progress for review regarding study milestones and gono-go criteria for approval of the UH3 phase and
3 complete FDA pre-submission for FDA input on proposed UH3 protocols to expand Sparrow Ascents indication for PTSD symptoms
Approximately twenty adults diagnosed with opioid use disorder and posttraumatic stress disorder initiating buprenorphine treatment at Gibson Center for Behavioral Change will complete a baseline assessment of substance use and mental health diagnostic measures before being randomized into the study Participants randomized to the active tAN condition will receive therapeutic stimulation to the trigeminal and vagus nerves through the Sparrow Ascent earpiece when they activate their Patient Controller Participants randomized to the active sham condition will receive only stimulation on the trigeminal nerve at a level that can be felt but is well below any therapeutic effect All participants will receive identical training for the Sparrow Ascent device and the only difference will be the condition-dependent programming of their Patient Controllers Participants begin using the Sparrow Ascent device within one week of buprenorphine induction at Gibson For the next 12 weeks as they continue through standard buprenorphine treatment with Gibson providers participants will independently administer stimulation at or above a recommended dosage schedule that decreases in frequency every four weeks during the active participation period ie Weeks 1-4 5-8 9-12 Device usage logs will be downloaded and assessed at weekly research visits throughout the active participation period to determine device adherence and provide feedback and assistance if needed After 12 weeks of device usage participants return their device and complete a post-assessment that repeats many of the baseline assessments to determine changes from baseline Buprenorphine treatment retention primary outcome at three months and six months secondary outcome post-randomization will be extracted from the electronic medical record
1 conduct a pilot randomized active sham-controlled test of transcutaneous auricular neurostimulation tAN with the Sparrow Ascent device to determine its acceptability tolerability feasibility and adherence in patients with OUD and PTSD starting buprenorphine BUP therapy
2 submit progress for review regarding study milestones and gono-go criteria for approval of the UH3 phase and
3 complete FDA pre-submission for FDA input on proposed UH3 protocols to expand Sparrow Ascents indication for PTSD symptoms
Approximately twenty adults diagnosed with opioid use disorder and posttraumatic stress disorder initiating buprenorphine treatment at Gibson Center for Behavioral Change will complete a baseline assessment of substance use and mental health diagnostic measures before being randomized into the study Participants randomized to the active tAN condition will receive therapeutic stimulation to the trigeminal and vagus nerves through the Sparrow Ascent earpiece when they activate their Patient Controller Participants randomized to the active sham condition will receive only stimulation on the trigeminal nerve at a level that can be felt but is well below any therapeutic effect All participants will receive identical training for the Sparrow Ascent device and the only difference will be the condition-dependent programming of their Patient Controllers Participants begin using the Sparrow Ascent device within one week of buprenorphine induction at Gibson For the next 12 weeks as they continue through standard buprenorphine treatment with Gibson providers participants will independently administer stimulation at or above a recommended dosage schedule that decreases in frequency every four weeks during the active participation period ie Weeks 1-4 5-8 9-12 Device usage logs will be downloaded and assessed at weekly research visits throughout the active participation period to determine device adherence and provide feedback and assistance if needed After 12 weeks of device usage participants return their device and complete a post-assessment that repeats many of the baseline assessments to determine changes from baseline Buprenorphine treatment retention primary outcome at three months and six months secondary outcome post-randomization will be extracted from the electronic medical record
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None