Snímání fyziologických příznaků vysazení opioidů a bažení u pacientů s poruchou užívání opioidů
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Brooke Le
Studijní záloha kontaktů
- Jméno: Caroline Benner
- Telefonní číslo: (210) 624-8046
- E-mail: clinicaltrials@sparkbiomedical.com
Studijní místa
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Minnesota
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Center City, Minnesota, Spojené státy, 55012
- Nábor
- Hazelden Betty Ford Foundation
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Kontakt:
- Tara Cantwell, MPH
- E-mail: tcantwell@hazeldenbettyford.org
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Kontakt:
- Laurie Zganjar
- E-mail: research@butlercenterresearch.org
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Vrchní vyšetřovatel:
- Quyen Ngo, PhD
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Ohio
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Columbus, Ohio, Spojené státy, 43201
- Aktivní, ne nábor
- Battelle Memorial Institute
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Participants between 18 and 50 years of age with a history of dependence on prescription or non-prescription opioids
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Short Opioid Withdrawal Scale Gossop (SOWS-Gossop)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Sleep Duration
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Navid Khodaparast, PhD, Chief Science Officer
- Ředitel studie: Melanie McWade, PhD, Senior Director of Clinical Operations
- Studijní židle: Carlos Tirado, MD, Medical Monitor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- SBM-OWP-09
- 1R43DA059448 (Grant/smlouva NIH USA)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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