オピオイド使用障害患者におけるオピオイド離脱と渇望の生理学的症状の感知
The primary objective of this trial is to measure changes in physiologic signals to quantify the status of the autonomic nervous system during opioid withdrawal and cravings.
調査の概要
詳細な説明
This is a prospective observational clinical trial in which 20 participants with a history of dependence on prescription or non-prescription opioids will be recruited for collection of physiologic data via wearable sensors during a 14-day inpatient detoxification treatment. The EmbracePlus Smartwatch and Corti Sensor will be worn continuously throughout the 14-day treatment course to detect heart rate, heart rate variability, skin conductance, skin temperature, motion, and cortisol levels.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Brooke Le
研究連絡先のバックアップ
- 名前：Caroline Benner
- 電話番号：(210) 624-8046
- メール：clinicaltrials@sparkbiomedical.com
研究場所
-
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Minnesota
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Center City、Minnesota、アメリカ、55012
- 募集
- Hazelden Betty Ford Foundation
-
コンタクト：
- Tara Cantwell, MPH
- メール：tcantwell@hazeldenbettyford.org
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コンタクト：
- Laurie Zganjar
- メール：research@butlercenterresearch.org
-
主任研究者：
- Quyen Ngo, PhD
-
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Ohio
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Columbus、Ohio、アメリカ、43201
- 積極的、募集していない
- Battelle Memorial Institute
-
-
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
サンプリング方法
調査対象母集団
Participants between 18 and 50 years of age with a history of dependence on prescription or non-prescription opioids
説明
Inclusion Criteria
- Participant has a recent history of opioid dependence; prescription or non-prescription
- Participant is currently taking, or plans to initiate, medications for opioid use disorder (MOUD)
- Participant is between 18 and 50 years of age
- Participant is English proficient
- Participant is able to provide informed consent and function at an intellectual level sufficient for study requirements
- Participant is willing to wear wearable sensors for 14 days
Exclusion Criteria
- Participant presents current evidence of an uncontrolled and/or clinically significant medical condition or psychiatric condition
- Participant has a history of epileptic seizures
- Participant has a history of neurological diseases or traumatic brain injury
- Participant has recent suicide attempt leading to current hospital admission or continued expressed suicidal ideation
- Subject has significant current suicidal ideation within 30 days prior to Screening as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) completed at Screening, that, in the opinion of the investigator, warrants exclusion from the trial
- Females who are pregnant or lactating
- Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
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
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Opioid Use Disorder
Participants with a history of dependence on prescription or non-prescription opioids |
The EmbracePlus is worn on the user's wrist and continuously collects raw data via specific sensors. These data can be wirelessly transmitted to a paired mobile device. The data received are analyzed by EmpaDSP, which computes the user physiological parameters. The Care App is responsible for transmitting raw data, device information, Care App-specific information, and computed physiological parameters to the Empatica Cloud. The device supports continuous data collection for monitoring of the following physiological parameters:
The EmbracePlus Watch has been used in previous human subject research studies for bio-physiological data collection in other medical conditions and have confirmed that there is minimal risk to participants. This device is therefore exempt from any IDE requirements. The Corti Wearable is a sweat sensor that is worn continuously measure cortisol, melatonin, tumor necrosis alpha interleukin-6 (IL-6) in the protein analytes in the sweat of participants via electrochemical impedance spectroscopy. The Corti Wearable comprises a plastic reader and a replaceable polymer sweat-sensing strip with zinc oxide (ZnO) coated electrodes that is worn on the participant's forearm. It is manufactured through a screen-printing technique that allows for an affinity-based interaction between a capture probe antibody and the target molecule generating electrochemical activity. The Cort Wearable has been used in previous human subject research studies for bio-physiological data collection in other medical conditions and have confirmed that there is minimal risk to participants. This device is therefore exempt from any IDE requirements. |
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 |
|---|---|---|
|
Short Opioid Withdrawal Scale Gossop (SOWS-Gossop)
時間枠：Daily throughout the 14-day inpatient detoxification treatment
|
Correlation of opioid withdrawal symptoms, as measured by the SOWS-Gossop, over time with biomarkers using the EmbracePlus Smartwatch and Corti Wearable. |
Daily throughout the 14-day inpatient detoxification treatment
|
|
Clinical Opioid Withdrawal Scale (COWS)
時間枠：Daily throughout the 14-day inpatient detoxification treatment
|
Correlation of opioid withdrawal symptoms, as measured by the COWS, over time with biomarkers using the EmbracePlus Smartwatch and Corti Wearable. |
Daily throughout the 14-day inpatient detoxification treatment
|
|
Opioid Craving Visual Analog Scale (OC-VAS)
時間枠：Daily throughout the 14-day inpatient detoxification treatment
|
Correlation of the intensity of opioid cravings, as measured by the OC-VAS, over time with biomarkers using the EmbracePlus Smartwatch and Corti Wearable. |
Daily throughout the 14-day inpatient detoxification treatment
|
|
Adverse Events
時間枠：Daily throughout the 14-day inpatient detoxification treatment
|
The primary safety endpoint will be the proportion of participants who experience one or more adverse events. |
Daily throughout the 14-day inpatient detoxification treatment
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Sleep Duration
時間枠：Daily throughout the 14-day inpatient detoxification treatment
|
Correlation of sleep duration and quality with opioid withdrawal symptoms as well as cravings |
Daily throughout the 14-day inpatient detoxification treatment
|
|
Stress Monitoring and Assessment Tool (SMART)
時間枠：Daily throughout the 14-day inpatient detoxification treatment
|
Correlation of stress score, as measured by the SMART, with biomarkers using the EmbracePlus Smartwatch and Corti Wearable. |
Daily throughout the 14-day inpatient detoxification treatment
|
|
Therapy Compliance
時間枠：Daily throughout the 14-day inpatient detoxification treatment
|
Correlation of compliance to recovery-related therapies (e.g. group therapy, individual counseling) with biomarkers using the EmbracePlus Smartwatch and Corti Wearable. |
Daily throughout the 14-day inpatient detoxification treatment
|
|
Drug Screening
時間枠：Once daily on screening/baseline day, study day 7, and study day 14 (14-day time frame)
|
Proportion of participants testing positive for Amphetamines, Buprenorphine, Benzodiazepines, Cocaine, Ethyl Glucuronide, Fentanyl, Synthetic Marijuana, Ecstasy, Methamphetamines, Methadone, Opiates / Morphine, Oxycodone, Cannabinoid (Marijuana), Xylazine, and Tramadol or any combination |
Once daily on screening/baseline day, study day 7, and study day 14 (14-day time frame)
|
|
Medication Use
時間枠：Daily throughout the 14-day inpatient detoxification treatment
|
Medication use and timing (medication name, dosage, and indication) |
Daily throughout the 14-day inpatient detoxification treatment
|
|
Wearable Sensors Compliance
時間枠：Daily throughout the 14-day inpatient detoxification treatment
|
Compliance to wearing wearable sensors (EmbracePlus Smartwatch and Corti Sensor) |
Daily throughout the 14-day inpatient detoxification treatment
|
協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Navid Khodaparast, PhD、Chief Science Officer
- スタディディレクター：Melanie McWade, PhD、Senior Director of Clinical Operations
- スタディチェア：Carlos Tirado, MD、Medical Monitor
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
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。