Using a device to help people with PTSD and opioid use disorder stay in treatment

IMBUE RETAIN: Transcutaneous Auricular Neurostimulation (tAN) for Patients With Co-occurring Posttraumatic Stress Disorder (PTSD) and Opioid Use Disorder Starting Buprenorphine Therapy

This study is testing if a device that uses gentle electrical stimulation can help people with PTSD and opioid use disorder stick to their treatment plan when starting a new medication.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Cincinnati (Academic / other)
• Locations: 1 site (Cape Girardeau, Missouri)
• Trial ID: NCT06130501 on ClinicalTrials.gov

What this trial studies

This research investigates the effects of transcutaneous auricular neurostimulation (tAN) delivered through the Sparrow Ascent device on individuals with co-occurring posttraumatic stress disorder (PTSD) and opioid use disorder (OUD) who are starting buprenorphine therapy. The study aims to assess the acceptability, tolerability, and feasibility of using the device to improve treatment retention over three months. Participants will be randomized to receive either active tAN or a sham treatment while monitoring their adherence to the device's usage. The study is supported by the HEAL Initiative and includes a pilot randomized controlled design.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 who are seeking buprenorphine therapy for opioid use disorder and meet the diagnostic criteria for both PTSD and moderate to severe opioid use disorder.

Not a fit: Patients who do not have a diagnosis of PTSD or opioid use disorder, or those who are not seeking buprenorphine therapy, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance treatment retention for patients with PTSD and opioid use disorder, leading to better health outcomes.

How similar studies have performed: While this approach is innovative, similar studies exploring neurostimulation techniques for substance use disorders have shown promise, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where this trial is running

Cape Girardeau, Missouri

• Gibson Center for Behavioral Change — Cape Girardeau, Missouri, United States (Recruiting)

Study contacts

• Principal investigator: Joel Sprunger, PhD — University of Cincinnati
• Study coordinator: Ashley Naeger, MSW

Conditions Posttraumatic Stress Disorder; Opioid Use Disorder; feasibility; medication for opioid use disorder; treatment retention; transcutaneous auricular neurostimulation