tAN for PTSD and OUD in Buprenorphine Therapy

NCT06130501 | Completed DMC FDA Device

• 1 other identifier: 1UG3DA059409-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 current prescription for buprenorphine at three months and six months after randomization.

Conditions

Opioid Use Disorder; Posttraumatic Stress Disorder

Keywords

feasibility; medication for opioid use disorder (buprenorphine); treatment retention; transcutaneous auricular neurostimulation

Outcome Measures

Primary Outcomes (1)

• 3-month Buprenorphine (BUP) Retention

  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.

  3 months post-randomization

Secondary Outcomes (27)

• Device Acceptability

  3 months post-randomization

• Device Tolerability

  3 months post-randomization

• Device Feasibility - Patient Ease of Use

  3 months post-randomization

• Device Feasibility - Patient Helpfulness

  3 months post-randomization

• Device Feasibility - Patient Value

  3 months post-randomization

Other Outcomes (7)

• Weekly PTSD Symptom Severity

  Weekly for 3 months post-randomization

• Weekly Opioid Withdrawal Symptom Severity Self Rated

  Weekly for 3 months post-randomization

• Weekly Opioid Withdrawal Symptom Severity Observer Rated

  Weekly for 3 months post-randomization

Study Arms (2)

Active tAN

EXPERIMENTAL

Participants receive active tAN with the Sparrow Ascent device from Spark Biomedical (Dallas, TX).

Device: Sparrow Ascent tAN

Active Sham

SHAM COMPARATOR

Participants receive the active sham version of the Sparrow Ascent device that limits stimulation to trigeminal innervation only and at a charge that is approximately 1000x lower than the active tAN condition.

Device: Sparrow Ascent Active Sham

Interventions

Sparrow Ascent Active Sham DEVICE

The Sparrow Ascent Active Sham is a modified version of the Sparrow Ascent tAN System that has been designed to provide sub-therapeutic stimulation to the trigeminal nerve only and no stimulation to the vagus nerve. The trigeminal nerve will receive 1 Hz stimulation at the temporomandibular region at an amplitude that is comfortable and perceptual. The pulse duration will be set to a value that does not exceed 250 μs in a square biphasic waveform. The patient controller device for the active sham will give the appearance that stimulation is being applied at both vagal and trigeminal electrode sites.

Active Sham

Sparrow Ascent tAN DEVICE

The Sparrow Ascent device from Spark Biomedical (Dallas, TX), applies stimulation frequencies of 15 Hz at the cymba concha (vagal innervation) and 100 Hz anterior to the tragus (trigeminal innervation). Both tAN and active sham conditions have square biphasic waveforms with identical pulse widths of 250 µs separated by a 125 µs interval between pulses. Stimulation is applied using a duty cycle of 5-minutes ON and 10 seconds OFF. The stimulation intensities (mA) will be programmed for each individual based on the highest amplitude for each channel that is both comfortable and perceptible. Patients using the device may alter the intensity of stimulation at these sites using the Patient Controller to achieve the desired effect.

Also known as: Sparrow Ascent System, Sparrow Ascent tAN System

Active tAN

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-65.
• Patient seeking buprenorphine therapy (BUP) for opioid use disorder and able to be randomized within 28 calendar days of induction on BUP.
• Meets Diagnostic and Statistical Manual - 5 (DSM-5) diagnostic criteria for moderate to severe opioid use disorder with induction on buprenorphine. This includes volunteers who have taken buprenorphine in the past and are re-starting, are currently receiving non-buprenorphine medication for opioid use disorder, or have taken non-buprenorphine medication for opioid use disorder in the past and are transitioning to buprenorphine therapy for the first time.
• Meets DSM-5 diagnostic criteria for posttraumatic stress disorder (PTSD).
• Is able to understand the study, and having understood, provide written informed consent in English.
• Provides permission to extract data from the participant's electronic medical record.

You may not qualify if:

• Unable to provide sufficient contact information (must provide at least two reliable indicators).
• Volunteers who will not undergo induction on BUP within the eligibility window for randomization.
• Volunteers who intend to, or will receive, inpatient substance use disorder (SUD) care at the time of randomization. Volunteers receiving inpatient detoxification care at the time of screening or baseline assessment are eligible if they will no longer be receiving inpatient care when they would be randomized for the study.
• Volunteers actively participating in evidence-based psychotherapy for PTSD (e.g., Prolonged Exposure, Cognitive Processing Therapy, etc.).
• Volunteers who will not have been stable on medications that affect PTSD (i.e., sertraline, paroxetine, venlafaxine, prazosin, or trazodone) for at least four weeks before they could be randomized.
• Volunteer presents current evidence of an uncontrolled and/or clinically significant medical or psychiatric condition that will impact their ability to comply with the study requirements or would make their study participation unsafe. This includes unmedicated bipolar disorder with a manic episode in the past month or unmedicated psychotic disorder.
• Volunteer has a history of epileptic seizure.
• Volunteer has a history of neurological disorder or traumatic brain injury with significant lasting effects (e.g., memory problems, emotional changes, behavioral changes).
• Volunteer had a suicide attempt leading to hospital admission in the past month or suicidal ideation with a plan and intent to act upon it in the past month.
• Volunteer has the presence of devices (e.g., pacemakers, cochlear prosthesis, neurostimulators).
• Volunteer has abnormal ear anatomy or an ear infection is present.
• Volunteer is pregnant or lactating.
• Volunteers of childbearing potential, not using adequate contraception as per investigator judgment or not willing to comply with contraception for the duration of the study's active participation period (i.e., 12 weeks following randomization).
• Volunteer has any other significant medical or psychosocial problems that, in the opinion of the investigator, would potentially cause harm to the participant, impact their ability to participate, or influence the results of the project's trial. These include circumstances such as impending incarceration, moving out of the area, or a general history of noncompliance.

Sponsors & Collaborators

• University of Cincinnati: lead
• Spark Biomedical, Inc.: collaborator

Study Sites (1)

Gibson Center for Behavioral Change

Cape Girardeau, Missouri, 63703, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Joel Sprunger, PhD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Research Coordinator, Project Manager, and Site PI will be unblinded so that the participant receives the appropriate device for their assigned treatment condition, they are able to provide technical support, and give the participant feedback on their dose compliance throughout the study. The participant, all outcomes assessors, the participant's buprenorphine care provider, and the PI will be blind to condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 1:1 randomization

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 14, 2023
• Study Start: July 1, 2024
• Primary Completion: March 10, 2026
• Study Completion: June 4, 2026
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The shared data will be made available to other users by no later than the main findings are accepted for publication or 1-year post-study completion, whichever comes first. Published studies will have their own subcollections in the master Open Science Framework (OSF) project collection with the exact dataset used for the manuscript. These subcollections will have DOIs to aid in findability. We will include the DOI in relevant publications. The de-identified data will be retained indefinitely.
• Access Criteria: Data will be findable for the research community through the OSF collection that will be established when this application is funded. We will reference the shared data in OSF in peer-reviewed publications and relevant webpages. For each publication, an OSF subcollection will be created within the master OSF project. Each subcollection will have a digital object identifier (DOI) associated with it. This data DOI will be referenced in the publication and associated presentations to allow the research community easy access to the exact data used in the publication. When these links are followed, researchers will view the instructions and requirements for establishing a data use agreement for access. Access to the data will be controlled and require a signed data use agreement. PI Sprunger will be responsible for administering these agreements.

Locations

US (1)