tAN for PTSD and OUD in Buprenorphine Therapy

Posttraumatic Stress Disorder Clinical Trial

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

Clinical Trial Summary

The goal of this research study 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 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.

Clinical Trial Description

The overall UG3/UH3 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 go/no-go criteria for approval of the UH3 phase; and

3. complete FDA pre-submission for FDA input on proposed UH3 protocols to expand Sparrow Ascent's 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 (i.e., 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. ;

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Substance-Related Disorders

• NCT number: NCT06130501
• Study type: Interventional
• Source: University of Cincinnati
• Contact: Ashley Naeger, MSW
• Phone: 573-803-4158
• Email: naegera@gibsonrecovery.org
• Status: Recruiting
• Phase: N/A
• Start date: June 14, 2024
• Completion date: June 2025