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Erkennen physiologischer Symptome von Opioidentzug und Heißhunger bei Patienten mit Opioidkonsumstörung

25. September 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

20

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Brooke Le

Studieren Sie die Kontaktsicherung

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 50 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

N/A

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: COHORT
  • Zeitperspektiven: PROSPECTIVE

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Opioid Use Disorder

Participants with a history of dependence on prescription or non-prescription opioids
Gerät: 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.

Gerät: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Short Opioid Withdrawal Scale Gossop (SOWS-Gossop)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Sleep Duration
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Spark Biomedical, Inc.

Mitarbeiter

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

Ermittler

  • Hauptermittler: Navid Khodaparast, PhD, Chief Science Officer
  • Studienleiter: Melanie McWade, PhD, Senior Director of Clinical Operations
  • Studienstuhl: Carlos Tirado, MD, Medical Monitor

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

19. Februar 2025

Primärer Abschluss (Geschätzt)

31. März 2027

Studienabschluss (Geschätzt)

31. Mai 2027

Studienanmeldedaten

Zuerst eingereicht

27. Juni 2024

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. Juni 2024

Zuerst gepostet (Tatsächlich)

5. Juli 2024

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

28. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • SBM-OWP-09
  • 1R43DA059448 (US NIH Stipendium/Vertrag)

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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