Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact
Clinical Trials in the USA / NCT06487533
Recruiting Observational

Sensing Physiological Symptoms of Opioid Withdrawal and Cravings in Patients With Opioid Use Disorder

NCT06487533 · tracked via the Priya Life Science USA tracker
Sponsor
Spark Biomedical, Inc
Phase
Observational
Started
2025-02-19
Last updated
2026-09-28

Condition(s) studied

Opioid WithdrawalOpioid Use Disorder

Investigational drug(s) / intervention(s)

EmbracePlus SmartwatchCorti Sensor

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.

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Short Opioid Withdrawal Scale Gossop (SOWS-Gossop) — 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.
  • Clinical Opioid Withdrawal Scale (COWS) — 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.
  • Opioid Craving Visual Analog Scale (OC-VAS) — 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.
  • Adverse Events — 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.

Trial sites (2)

FacilityCityRegionStatus
Hazelden Betty Ford Foundation Center City Minnesota Recruiting
Battelle Memorial Institute Columbus Ohio Active Not Recruiting

More Spark Biomedical, Inc. trials in the USA

Delivering tAN to Reduce HMB: The LUNA Study Recruiting
tAN for Substance Use Disorder Recruiting
Neurostimulation to Improve NOWS Outcomes Active, not recruiting

Other trials for the same condition

A Study of Cebranopadol for Opioid Withdrawal Symptoms in Adults With Chronic Pain Recruiting
Study to Assess the Use of Tezampanel for Opioid Withdrawal Syndrome in Treatment-Seeking Patients With Opioid Use Disorder Recruiting
Virtual Reality Cognitive-Affective Training for Opioid Use Disorder- A Phase 2 RCT Active, not recruiting
Medically Supervised Ibogaine With 12-Month Digital Recovery Support for Opioid Use Disorder Starting soon
Remotely Observed Methadone Evaluation II Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06487533 on ClinicalTrials.gov ↗ ← All trials in the USA