Sensing Physiological Symptoms of Opioid Withdrawal and Cravings in Patients With Opioid Use Disorder (Closed-Loop)

June 1, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Brooke Le

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Opioid Use Disorder
Participants with a history of dependence on prescription or non-prescription opioids
Device: 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.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Daily throughout the 14-day inpatient detoxification treatment
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.
Daily throughout the 14-day inpatient detoxification treatment
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.
Daily throughout the 14-day inpatient detoxification treatment
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.
Daily throughout the 14-day inpatient detoxification treatment

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sleep Duration
Time Frame: 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
Drug Screening
Time Frame: 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
Time Frame: 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
Time Frame: 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
Stress Monitoring and Assessment Tool (SMART)
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Spark Biomedical, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)
Battelle Memorial Institute
Hazelden Betty Ford Foundation
The HEAL Initiative

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Navid Khodaparast, PhD, Chief Science Officer
  • Study Director: Melanie McWade, PhD, Senior Director of Clinical Operations
  • Study Chair: Carlos Tirado, MD, Medical Monitor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 19, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SBM-OWP-09
  • 1R43DA059448 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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