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Fornemmelse af fysiologiske symptomer på opioidabstinenser og trang hos patienter med opioidbrugsforstyrrelse

25. september 2026 opdateret af: Spark Biomedical, Inc.

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

20

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Brooke Le

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 50 år (Voksen)

Tager imod sunde frivillige

N/A

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Participants between 18 and 50 years of age with a history of dependence on prescription or non-prescription opioids

Beskrivelse

Inclusion Criteria

  1. Participant has a recent history of opioid dependence; prescription or non-prescription
  2. Participant is currently taking, or plans to initiate, medications for opioid use disorder (MOUD)
  3. Participant is between 18 and 50 years of age
  4. Participant is English proficient
  5. Participant is able to provide informed consent and function at an intellectual level sufficient for study requirements
  6. Participant is willing to wear wearable sensors for 14 days

Exclusion Criteria

  1. Participant presents current evidence of an uncontrolled and/or clinically significant medical condition or psychiatric condition
  2. Participant has a history of epileptic seizures
  3. Participant has a history of neurological diseases or traumatic brain injury
  4. Participant has recent suicide attempt leading to current hospital admission or continued expressed suicidal ideation
  5. 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
  6. Females who are pregnant or lactating
  7. 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Opioid Use Disorder

Participants with a history of dependence on prescription or non-prescription opioids
Enhed: EmbracePlus Smartwatch

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:

  • Peripheral skin temperature
  • Electrodermal activity
  • Blood Oxygen Saturation under no motion conditions
  • Activity associated with movement during sleep.

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.

Enhed: Corti Sensor

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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Short Opioid Withdrawal Scale Gossop (SOWS-Gossop)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sleep Duration
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Spark Biomedical, Inc.

Samarbejdspartnere

National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)
Battelle Memorial Institute
Hazelden Betty Ford Foundation
The HEAL Initiative

Efterforskere

  • Ledende efterforsker: Navid Khodaparast, PhD, Chief Science Officer
  • Studieleder: Melanie McWade, PhD, Senior Director of Clinical Operations
  • Studiestol: Carlos Tirado, MD, Medical Monitor

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

19. februar 2025

Primær færdiggørelse (Anslået)

31. marts 2027

Studieafslutning (Anslået)

31. maj 2027

Datoer for studieregistrering

Først indsendt

27. juni 2024

Først indsendt, der opfyldte QC-kriterier

27. juni 2024

Først opslået (Faktiske)

5. juli 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SBM-OWP-09
  • 1R43DA059448 (U.S. NIH-bevilling/kontrakt)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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