ブプレノルフィン療法における PTSD および OUD に対する tAN
IMBUE RETAIN: ブプレノルフィン療法を開始している、心的外傷後ストレス障害 (PTSD) とオピオイド使用障害を併発している患者に対する経皮的耳介神経刺激 (tAN)
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Missouri
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Cape Girardeau、Missouri、アメリカ、63703
- Gibson Center for Behavioral Change
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Active tAN
Participants receive active tAN with the Sparrow Ascent device from Spark Biomedical (Dallas, TX). |
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.
他の名前：
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偽コンパレータ：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. |
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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3-month Buprenorphine (BUP) Retention
時間枠：3 months post-randomization
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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
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Device Acceptability
時間枠：3 months post-randomization
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The proportion of participants registering use of the device. |
3 months post-randomization
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Device Tolerability
時間枠：3 months post-randomization
|
The proportions of participants endorsing that the device caused pain or discomfort to the ear, discontinue the study due to a device-related Adverse Event (AE), and any device-related Serious Adverse Events (SAEs). |
3 months post-randomization
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Device Feasibility - Patient Ease of Use
時間枠：3 months post-randomization
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The proportion of participants who endorse that the device was easy to use as measured by the Device Usability Questionnaire using a five-item ordinal scale ranging from Strongly disagree to Strongly agree. |
3 months post-randomization
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Device Feasibility - Patient Helpfulness
時間枠：3 months post-randomization
|
The proportion of participants who endorse that the device helped them take their buprenorphine as prescribed as measured by the Device Usability Questionnaire using a five-item ordinal scale ranging from Strongly disagree to Strongly agree. |
3 months post-randomization
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Device Feasibility - Patient Value
時間枠：3 months post-randomization
|
The proportion of participants who endorse that the device is valuable for people with PTSD and OUD taking buprenorphine as measured by the Device Usability Questionnaire using a five-item ordinal scale ranging from Strongly disagree to Strongly agree. |
3 months post-randomization
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Device Feasibility - Provider Helpfulness
時間枠：3 months post-randomization
|
The proportion of provider reports of patient device usage endorsing that the device helped their participants take their buprenorphine as prescribed as measured by the Provider Feedback Questionnaire using a five-item ordinal scale ranging from Strongly disagree to Strongly agree. |
3 months post-randomization
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Device Feasibility - Provider Utility
時間枠：3 months post-randomization
|
The proportion of provider reports of patient device usage endorsing that the device has utility as an adjunct to buprenorphine therapy as measured by the Provider Feedback Questionnaire using a five-item ordinal scale ranging from Strongly disagree to Strongly agree. |
3 months post-randomization
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Device Feasibility - Provider Value
時間枠：3 months post-randomization
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The proportion of provider reports of patient device usage endorsing that the device has value as a treatment option for patients with PTSD and OUD taking buprenorphine as measured by the Provider Feedback Questionnaire using a five-item ordinal scale ranging from Strongly disagree to Strongly agree. |
3 months post-randomization
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Device Feasibility - Provider Barrier
時間枠：3 months post-randomization
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The proportion of provider reports of patient device usage endorsing that the device does not make it harder for their participant to take their medication as measured by the Provider Feedback Questionnaire using a five-item ordinal scale ranging from Strongly disagree to Strongly agree. |
3 months post-randomization
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Device Adherence
時間枠：3 months post-randomization
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The proportion of participants who meet or exceed the minimum dosing schedule for at least 75% (9 of 12) weekly research visits. |
3 months post-randomization
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Buprenorphine Medication Compliance
時間枠：3 months post-randomization
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The proportions of weekly research visits with a positive result for buprenorphine in the urine drug test and self-reported buprenorphine administration as prescribed. |
3 months post-randomization
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Substance Use
時間枠：3 months post-randomization
|
The proportions of weekly research visits with self-reported non-prescribed substance use (e.g., opioid use, stimulant use) as measured by the Timeline Follow-back Method and positive urine drug test results. |
3 months post-randomization
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PTSD Symptom Severity - Self Rated
時間枠：3 months post-randomization
|
Mean change in PTSD Checklist for DSM-5 (PCL-5) symptom severity scores from baseline to post-treatment assessment. PCL-5 scores range from 0 - 80 with a higher score indicating more severe trauma-related distress due to PTSD symptoms. |
3 months post-randomization
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PTSD Symptom Severity - Clinician Rated
時間枠：3 months post-randomization
|
Mean change in Clinician-administered PTSD Scale for DSM-5 (CAPS-5) symptom severity scores from baseline to post-treatment assessment. CAPS-5 scores range from 0 - 80 with a higher score indicating more severe trauma-related distress due to PTSD symptoms. |
3 months post-randomization
|
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PTSD Remission Status
時間枠：3 months post-randomization
|
Change in PTSD diagnostic status according to the Clinician-administered PTSD Scale for DSM-5 (CAPS-5). |
3 months post-randomization
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Opioid Withdrawal Symptom Severity - Self Rated
時間枠：3 months post-randomization
|
Mean change in self-reported opioid withdrawal symptom severity on the 10-item Short Opiate Withdrawal Scale - Gossop (SOWS-Gossop). Participants rate each item on a scale ranging from 0 (None) to 3 (Severe). The total scale score ranges between 0 - 30, with higher scores indicating more severe withdrawal symptoms. |
3 months post-randomization
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Opioid Withdrawal Symptom Severity - Observer Rated
時間枠：3 months post-randomization
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Mean change in observer-rated severity on the 11-item Clinical Opiate Withdrawal Scale (COWS). The total score on the measure ranges from 0-48, with higher scores indicating greater severity of opioid withdrawal signs and symptoms. |
3 months post-randomization
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Opioid-related Craving
時間枠：3 months post-randomization
|
Mean change in self-reported opioid craving scores on the five-item Penn Craving Scale (PCS). Total scores on this measure range from 0 - 30, with higher scores indicating more severe craving for opioids. |
3 months post-randomization
|
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Overall Quality of Life and General Health
時間枠：3 months post-randomization
|
Mean change in self-reported Overall Quality of Life and General Health domain scores using the United States version of the World Health Organization (WHO) Quality of Life Scale - Brief. Participants rate items using a five-point Likert scale ranging from Not at all (1) to Completely (5). Raw scores within this domain range from 2-10. Higher scores indicate a higher overall quality of life and general health. |
3 months post-randomization
|
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Physical Health
時間枠：3 months post-randomization
|
Mean change in self-reported Physical Health domain scores using the United States version of the WHO Quality of Life Scale - Brief. Participants rate items using a five-point Likert scale ranging from Not at all (1) to Completely (5). Raw scores within this domain range from 7-35. Higher scores indicate a higher quality of physical health. |
3 months post-randomization
|
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Psychological Health
時間枠：3 months post-randomization
|
Mean change in self-reported Psychological domain scores using the United States version of the WHO Quality of Life Scale - Brief. Participants rate items using a five-point Likert scale ranging from Not at all (1) to Completely (5). Raw scores within this domain range from 6-30. Higher scores indicate a higher quality of psychological health. |
3 months post-randomization
|
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Quality of Social Relationships
時間枠：3 months post-randomization
|
Mean change in self-reported Social Relationships domain scores using the United States version of the WHO Quality of Life Scale - Brief. Participants rate items using a five-point Likert scale ranging from Not at all (1) to Completely (5). Raw scores within this domain range from 3-15. Higher scores indicate a higher quality of social relationships. |
3 months post-randomization
|
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Quality of Environment
時間枠：3 months post-randomization
|
Mean change in self-reported Environment domain scores using the United States version of the WHO Quality of Life Scale - Brief. Participants rate items using a five-point Likert scale ranging from Not at all (1) to Completely (5). Raw scores within this domain range from 8-40. Higher scores indicate a higher quality of environment. |
3 months post-randomization
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Recovery Capital
時間枠：3 months post-randomization
|
Mean change in self-reported recovery capital scores on the Brief Assessment of Recovery Capital - 10 (BARC-10). Scores on this measure range from 6-60, with higher scores indicating greater recovery capital and a higher likelihood of sustaining recovery from substance use disorder. |
3 months post-randomization
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Depression Symptom Severity
時間枠：3 months post-randomization
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Mean change in self-reported depression symptom severity as measured by the Patient Health Questionnaire - 9 (PHQ-9). Scores on this measure range from 0-27, with higher scores indicating more severe depression-related distress. |
3 months post-randomization
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Anxiety Symptom Severity
時間枠：3 months post-randomization
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Mean change in self-reported depression symptom severity as measured by General Anxiety Disorder - 7 (GAD-7). Scores on this measure range from 0-21, with higher scores indicating more severe anxiety-related distress. |
3 months post-randomization
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Blinding to Condition
時間枠：3 months post-randomization
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The proportion of participants randomized to the comparison group who believe that they were in the active tAN condition. |
3 months post-randomization
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Weekly PTSD Symptom Severity
時間枠：Weekly for 3 months post-randomization
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Weekly ratings of self-reported PTSD symptom severity on the PTSD Checklist for DSM-5 (PCL-5). PCL-5 scores range from 0 - 80 with a higher score indicating more severe trauma-related distress due to PTSD symptoms. |
Weekly for 3 months post-randomization
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Weekly Opioid Withdrawal Symptom Severity Self Rated
時間枠：Weekly for 3 months post-randomization
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Weekly ratings of opioid withdrawal symptom severity on the Short Opiate Withdrawal Scale - Gossop (SOWS-Gossop). Participants rate each item on a scale ranging from 0 (None) to 3 (Severe). The total scale score ranges between 0 - 30, with higher scores indicating more severe withdrawal symptoms. |
Weekly for 3 months post-randomization
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Weekly Opioid Withdrawal Symptom Severity Observer Rated
時間枠：Weekly for 3 months post-randomization
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Weekly ratings of opioid withdrawal symptom severity on the Clinical Opiate Withdrawal Scale (COWS). The total score on the measure ranges from 0-48, with higher scores indicating greater severity of opioid withdrawal signs and symptoms. |
Weekly for 3 months post-randomization
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Weekly Opioid-related Craving
時間枠：Weekly for 3 months post-randomization
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Weekly ratings of self-reported opioid-related craving on the PCS. Total scores on this measure range from 0 - 30, with higher scores indicating more severe craving for opioids. |
Weekly for 3 months post-randomization
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Weekly Substance Use
時間枠：Weekly for 3 months post-randomization
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Weekly non-prescribed substance use as indicated by Timeline Follow-back and urine drug test. |
Weekly for 3 months post-randomization
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Bi-weekly Depression Symptom Severity
時間枠：Bi-weekly for 3 months post-randomization
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Bi-weekly scores on the Patient Health Questionnaire - 9 (PHQ-9). Scores on this measure range from 0-27, with higher scores indicating more severe depression-related distress. |
Bi-weekly for 3 months post-randomization
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Bi-weekly Anxiety Symptom Severity
時間枠：Bi-weekly for 3 months post-randomization
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Bi-weekly scores on the General Anxiety Disorder - 7 (GAD-7). Scores on this measure range from 0-21, with higher scores indicating more severe anxiety-related distress. |
Bi-weekly for 3 months post-randomization
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Joel Sprunger, PhD、University of Cincinnati
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 1UG3DA059409-01 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
We will create a completely de-identified dataset to prevent linkages to individual research participants. This includes removal of all Protected Health Information (PHI) and indirect identifiers that are not listed as PHI but could lead to "deductive disclosure" such as site numbers.
Proprietary protocols regarding the Sparrow device are the intellectual property of Spark Biomedical, Inc. and will not be shared.
This dataset, with related study materials (e.g., study protocol, define file, data dictionary, etc.), will be made available to investigators with a data-sharing agreement. The data sharing agreement will require commitment to: 1) not re-disclose the data; 2) secure the data; 3) use the data for research purposes only; 4) make no attempt to identify individual participants; 5) destroy the data once the planned research activities have been completed; and 6) follow all relevant National Institutes of Health (NIH) policies.
IPD 共有時間枠
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.
IPD 共有アクセス基準
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.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。