Känna fysiologiska symtom på opioidabstinens och sug hos patienter med opioidanvändningsstörning
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Brooke Le
Studera Kontakt Backup
- Namn: Caroline Benner
- Telefonnummer: (210) 624-8046
- E-post: clinicaltrials@sparkbiomedical.com
Studieorter
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Minnesota
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Center City, Minnesota, Förenta staterna, 55012
- Rekrytering
- Hazelden Betty Ford Foundation
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Kontakt:
- Tara Cantwell, MPH
- E-post: tcantwell@hazeldenbettyford.org
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Kontakt:
- Laurie Zganjar
- E-post: research@butlercenterresearch.org
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Huvudutredare:
- Quyen Ngo, PhD
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Ohio
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Columbus, Ohio, Förenta staterna, 43201
- Aktiv, inte rekryterande
- Battelle Memorial Institute
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Participants between 18 and 50 years of age with a history of dependence on prescription or non-prescription opioids
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Short Opioid Withdrawal Scale Gossop (SOWS-Gossop)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Sleep Duration
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Navid Khodaparast, PhD, Chief Science Officer
- Studierektor: Melanie McWade, PhD, Senior Director of Clinical Operations
- Studiestol: Carlos Tirado, MD, Medical Monitor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SBM-OWP-09
- 1R43DA059448 (U.S.S. NIH-anslag/kontrakt)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
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