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NCT06487533From ClinicalTrials.govRecruiting

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

  • Opioid Withdrawal
  • Opioid Use Disorder

At a glance

Phase
Phase not stated
Study type
Observational
Sponsor
Spark Biomedical, Inc.
Enrolment target
20
Started
19 February 2025
Main results due
31 March 2027
Study sites
2
Registry updated
28 September 2026

Can you take part?

  • Ages 18 years to 50 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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

What this study is about

In the sponsor’s own words, from the registry.

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 sites(2)

  • Hazelden Betty Ford Foundation

    Center City, Minnesota, United States

    Recruiting

  • Battelle Memorial Institute

    Columbus, Ohio, United States

    Active, not recruiting

Showing 2 of 2 sites. 1 of the 2 sites on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06487533. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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