Opioidien käytön häiriöstä kärsivien potilaiden opioidien vieroittumisen ja halun fysiologisten oireiden tunnistaminen
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.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Brooke Le
Tutki yhteystietojen varmuuskopiointi
- Nimi: Caroline Benner
- Puhelinnumero: (210) 624-8046
- Sähköposti: clinicaltrials@sparkbiomedical.com
Opiskelupaikat
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Minnesota
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Center City, Minnesota, Yhdysvallat, 55012
- Rekrytointi
- Hazelden Betty Ford Foundation
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Ottaa yhteyttä:
- Tara Cantwell, MPH
- Sähköposti: tcantwell@hazeldenbettyford.org
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Ottaa yhteyttä:
- Laurie Zganjar
- Sähköposti: research@butlercenterresearch.org
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Päätutkija:
- Quyen Ngo, PhD
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Ohio
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Columbus, Ohio, Yhdysvallat, 43201
- Aktiivinen, ei rekrytointi
- Battelle Memorial Institute
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
Participants between 18 and 50 years of age with a history of dependence on prescription or non-prescription opioids
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Havaintomallit: COHORT
- Aikanäkymät: PROSPECTIVE
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
|---|---|
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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. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Short Opioid Withdrawal Scale Gossop (SOWS-Gossop)
Aikaikkuna: Daily throughout the 14-day inpatient detoxification treatment
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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
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Clinical Opioid Withdrawal Scale (COWS)
Aikaikkuna: Daily throughout the 14-day inpatient detoxification treatment
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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
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Opioid Craving Visual Analog Scale (OC-VAS)
Aikaikkuna: Daily throughout the 14-day inpatient detoxification treatment
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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
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Adverse Events
Aikaikkuna: Daily throughout the 14-day inpatient detoxification treatment
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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
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Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Sleep Duration
Aikaikkuna: Daily throughout the 14-day inpatient detoxification treatment
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Correlation of sleep duration and quality with opioid withdrawal symptoms as well as cravings |
Daily throughout the 14-day inpatient detoxification treatment
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Stress Monitoring and Assessment Tool (SMART)
Aikaikkuna: Daily throughout the 14-day inpatient detoxification treatment
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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
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Therapy Compliance
Aikaikkuna: Daily throughout the 14-day inpatient detoxification treatment
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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
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Drug Screening
Aikaikkuna: Once daily on screening/baseline day, study day 7, and study day 14 (14-day time frame)
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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)
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Medication Use
Aikaikkuna: Daily throughout the 14-day inpatient detoxification treatment
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Medication use and timing (medication name, dosage, and indication) |
Daily throughout the 14-day inpatient detoxification treatment
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Wearable Sensors Compliance
Aikaikkuna: Daily throughout the 14-day inpatient detoxification treatment
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Compliance to wearing wearable sensors (EmbracePlus Smartwatch and Corti Sensor) |
Daily throughout the 14-day inpatient detoxification treatment
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Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Navid Khodaparast, PhD, Chief Science Officer
- Opintojohtaja: Melanie McWade, PhD, Senior Director of Clinical Operations
- Opintojen puheenjohtaja: Carlos Tirado, MD, Medical Monitor
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- SBM-OWP-09
- 1R43DA059448 (Yhdysvaltain NIH-apuraha/sopimus)
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
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