Detección de síntomas fisiológicos de abstinencia y antojos de opioides en pacientes con trastorno por consumo de opioides
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Brooke Le
Copia de seguridad de contactos de estudio
- Nombre: Caroline Benner
- Número de teléfono: (210) 624-8046
- Correo electrónico: clinicaltrials@sparkbiomedical.com
Ubicaciones de estudio
-
-
Minnesota
-
Center City, Minnesota, Estados Unidos, 55012
- Reclutamiento
- Hazelden Betty Ford Foundation
-
Contacto:
- Tara Cantwell, MPH
- Correo electrónico: tcantwell@hazeldenbettyford.org
-
Contacto:
- Laurie Zganjar
- Correo electrónico: research@butlercenterresearch.org
-
Investigador principal:
- Quyen Ngo, PhD
-
-
Ohio
-
Columbus, Ohio, Estados Unidos, 43201
- Activo, no reclutando
- Battelle Memorial Institute
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Participants between 18 and 50 years of age with a history of dependence on prescription or non-prescription opioids
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Short Opioid Withdrawal Scale Gossop (SOWS-Gossop)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Sleep Duration
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Navid Khodaparast, PhD, Chief Science Officer
- Director de estudio: Melanie McWade, PhD, Senior Director of Clinical Operations
- Silla de estudio: Carlos Tirado, MD, Medical Monitor
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SBM-OWP-09
- 1R43DA059448 (Subvención/contrato del NIH de EE. UU.)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .