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Het waarnemen van fysiologische symptomen van opioïdenontwenning en hunkeren naar opioïden bij patiënten met een opioïdengebruiksstoornis

25 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

20

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Brooke Le

Studie Contact Back-up

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 50 jaar (Volwassen)

Accepteert gezonde vrijwilligers

NVT

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: COHORT
  • Tijdsperspectieven: PROSPECTIVE

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Opioid Use Disorder

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

Apparaat: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Short Opioid Withdrawal Scale Gossop (SOWS-Gossop)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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 uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Sleep Duration
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Spark Biomedical, Inc.

Medewerkers

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

Onderzoekers

  • Hoofdonderzoeker: Navid Khodaparast, PhD, Chief Science Officer
  • Studie directeur: Melanie McWade, PhD, Senior Director of Clinical Operations
  • Studie stoel: Carlos Tirado, MD, Medical Monitor

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

19 februari 2025

Primaire voltooiing (Geschat)

31 maart 2027

Studie voltooiing (Geschat)

31 mei 2027

Studieregistratiedata

Eerst ingediend

27 juni 2024

Eerst ingediend dat voldeed aan de QC-criteria

27 juni 2024

Eerst geplaatst (Werkelijk)

5 juli 2024

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 september 2026

Laatste update ingediend die voldeed aan QC-criteria

25 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • SBM-OWP-09
  • 1R43DA059448 (Subsidie/contract van de Amerikaanse NIH)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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