IMBUE RETAIN: Transcutaneous Auricular Neurostimulation (tAN) for Patients With Co-occurring Posttraumatic Stress Disorder (PTSD) and Opioid Use Disorder Starting Buprenorphine Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- 3-month Buprenorphine (BUP) Retention
研究概览
简要总结
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.
详细描述
Supported by the HEAL Initiative (https://heal.nih.gov), 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:
- 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;
- submit progress for review regarding study milestones and go/no-go criteria for approval of the UH3 phase; and
- 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 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 28 calendar days of buprenorphine induction. For the next 12 weeks, as they continue through standard buprenorphine treatment, 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Active tAN
Participants receive active tAN with the Sparrow Ascent device from Spark Biomedical (Dallas, TX).
干预措施: Sparrow Ascent tAN (Device)
Active Sham
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.
干预措施: Sparrow Ascent Active Sham (Device)
结局指标
主要结局
3-month Buprenorphine (BUP) Retention
时间窗: 3 months post-randomization
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.
次要结局
- Device Feasibility - Patient Ease of Use(3 months post-randomization)
- Device Tolerability(3 months post-randomization)
- Device Acceptability(3 months post-randomization)
- Device Feasibility - Patient Helpfulness(3 months post-randomization)
- Device Feasibility - Patient Value(3 months post-randomization)
- Buprenorphine Medication Compliance(3 months post-randomization)
- Device Feasibility - Provider Helpfulness(3 months post-randomization)
- Device Adherence(3 months post-randomization)
- PTSD Symptom Severity - Self Rated(3 months post-randomization)
- PTSD Symptom Severity - Clinician Rated(3 months post-randomization)
- Opioid-related Craving(3 months post-randomization)
- Psychological Health(3 months post-randomization)
- Quality of Environment(3 months post-randomization)
- Device Feasibility - Provider Utility(3 months post-randomization)
- Opioid Withdrawal Symptom Severity - Self Rated(3 months post-randomization)
- Physical Health(3 months post-randomization)
- Depression Symptom Severity(3 months post-randomization)
- Device Feasibility - Provider Value(3 months post-randomization)
- Device Feasibility - Provider Barrier(3 months post-randomization)
- Opioid Withdrawal Symptom Severity - Observer Rated(3 months post-randomization)
- Overall Quality of Life and General Health(3 months post-randomization)
- Blinding to Condition(3 months post-randomization)
- Substance Use(3 months post-randomization)
- PTSD Remission Status(3 months post-randomization)
- Quality of Social Relationships(3 months post-randomization)
- Recovery Capital(3 months post-randomization)
- Anxiety Symptom Severity(3 months post-randomization)
研究者
Joel G Sprunger, PhD
Assistant Professor
University of Cincinnati