Opioid WithdrawalNCT06487533
Sensing Physiological Symptoms of Opioid Withdrawal and Cravings in Patients With Opioid Use Disorder
An observational study of Opioid Withdrawal and Opioid Use Disorder, run by Spark Biomedical, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Opioid Withdrawal, Opioid Use Disorder
- What is being tested?
- EmbracePlus Smartwatch and Corti Sensor
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Feb 2025to 31 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Adult
Study population: Participants between 18 and 50 years of age with a history of dependence on prescription or non-prescription opioids
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brooke Le contact
United States2 sites, 1 recruiting
- Recruiting
Hazelden Betty Ford Foundation
Center City, Minnesota, 55012
Laurie Zganjar, research@butlercenterresearch.org
Tara Cantwell, MPH, tcantwell@hazeldenbettyford.org
- Active, not recruiting
Battelle Memorial Institute
Columbus, Ohio, 43201
About this study
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.
Read the detailed description
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.
- Conditions
- Opioid Withdrawal, Opioid Use Disorder
- Being tested
- EmbracePlus Smartwatch, Corti Sensor
- Keywords
- Physiological Signals, Opioid, Detoxification, Cravings, Autonomic Nervous System
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmbracePlus SmartwatchDevice
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 SensorDevice
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 group | Role | What they receive |
|---|---|---|
| Opioid Use Disorder | Participants with a history of dependence on prescription or non-prescription opioids Receives: Device: EmbracePlus Smartwatch; Device: Corti Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Opioid Withdrawal Scale Gossop (SOWS-Gossop)
Correlation of opioid withdrawal symptoms, as measured by the SOWS-Gossop, over time with biomarkers using the EmbracePlus Smartwatch and Corti Wearable.
Measured: Daily throughout the 14-day inpatient detoxification treatment
Clinical Opioid Withdrawal Scale (COWS)
Correlation of opioid withdrawal symptoms, as measured by the COWS, over time with biomarkers using the EmbracePlus Smartwatch and Corti Wearable.
Measured: Daily throughout the 14-day inpatient detoxification treatment
Opioid Craving Visual Analog Scale (OC-VAS)
Correlation of the intensity of opioid cravings, as measured by the OC-VAS, over time with biomarkers using the EmbracePlus Smartwatch and Corti Wearable.
Measured: Daily throughout the 14-day inpatient detoxification treatment
Adverse Events
The primary safety endpoint will be the proportion of participants who experience one or more adverse events.
Measured: Daily throughout the 14-day inpatient detoxification treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start19 Feb 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid WithdrawalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spark Biomedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Battelle Memorial Institute, Hazelden Betty Ford Foundation, National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA), The HEAL Initiative
- Responsible party
- Sponsor
- Investigators
- Navid Khodaparast, PhD, Principal investigator, Chief Science OfficerMelanie McWade, PhD, Study director, Senior Director of Clinical OperationsCarlos Tirado, MD, Study chair, Medical Monitor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487533
- Sponsor's protocol ID
- SBM-OWP-09
- Other IDs
- 1R43DA059448
- Status last verified
- Sep 2026
- First submitted
- 27 Jun 2024
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensing Physiological Symptoms of Opioid Withdrawal and Cravings in Patients With Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT06487533
- Acronym / sponsor ID
- SBM-OWP-09
- Conditions
- Opioid Withdrawal, Opioid Use Disorder
- Keywords
- Physiological Signals, Opioid, Detoxification, Cravings, Autonomic Nervous System
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Spark Biomedical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Battelle Memorial Institute, Hazelden Betty Ford Foundation, National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA), The HEAL Initiative
- Study start
- 19 Feb 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Opioid Use Disorder | – | Device: EmbracePlus Smartwatch, Device: Corti SensorParticipants with a history of dependence on prescription or non-prescription opioids |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- Participants between 18 and 50 years of age with a history of dependence on prescription or non-prescription opioids
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmbracePlus SmartwatchThe 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. | Device | Opioid Use Disorder |
| Corti SensorThe 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. | Device | Opioid Use Disorder |
Primary outcome
Short Opioid Withdrawal Scale Gossop (SOWS-Gossop)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brooke Le contact
Navid Khodaparast, PhD principal investigator
Chief Science Officer
Melanie McWade, PhD study director
Senior Director of Clinical Operations
Carlos Tirado, MD study chair
Medical Monitor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Withdrawal and Opioid Use Disorder, run by Spark Biomedical, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline Benner ((210) 624-8046, clinicaltrials@sparkbiomedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Opioid Withdrawal Scale Gossop (SOWS-Gossop) (time frame: Daily throughout the 14-day inpatient detoxification treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.