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Détection des symptômes physiologiques du sevrage et des envies d'opioïdes chez les patients souffrant de troubles liés à l'usage d'opioïdes

25 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

20

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Brooke Le

Sauvegarde des contacts de l'étude

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 50 ans (Adulte)

Accepte les volontaires sains

N/A

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: COHORT
  • Perspectives temporelles: PROSPECTIVE

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Opioid Use Disorder

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

Dispositif: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Short Opioid Withdrawal Scale Gossop (SOWS-Gossop)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Sleep Duration
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Spark Biomedical, Inc.

Collaborateurs

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

Les enquêteurs

  • Chercheur principal: Navid Khodaparast, PhD, Chief Science Officer
  • Directeur d'études: Melanie McWade, PhD, Senior Director of Clinical Operations
  • Chaise d'étude: Carlos Tirado, MD, Medical Monitor

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

19 février 2025

Achèvement primaire (Estimé)

31 mars 2027

Achèvement de l'étude (Estimé)

31 mai 2027

Dates d'inscription aux études

Première soumission

27 juin 2024

Première soumission répondant aux critères de contrôle qualité

27 juin 2024

Première publication (Réel)

5 juillet 2024

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

25 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • SBM-OWP-09
  • 1R43DA059448 (Subvention/contrat des NIH des États-Unis)

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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