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Opioid Use Disorder for Opioid Withdrawal Syndrome (Closed-Loop Trial)

N/A
Waitlist Available
Research Sponsored by Spark Biomedical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up once daily on screening/baseline day, study day 7, and study day 14 (14-day time frame)
Awards & highlights

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.

Eligible Conditions
  • Opioid Withdrawal Syndrome
  • Opioid Use Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~once daily on screening/baseline day, study day 7, and study day 14 (14-day time frame)
This trial's timeline: 3 weeks for screening, Varies for treatment, and once daily on screening/baseline day, study day 7, and study day 14 (14-day time frame) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse Events
Clinical Opioid Withdrawal Scale (COWS)
Opioid Craving Visual Analog Scale (OC-VAS)
+1 more
Other study objectives
Drug Screening
Medication Use
Sleep Duration
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Opioid Use DisorderExperimental Treatment2 Interventions
Participants with a history of dependence on prescription or non-prescription opioids

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Who is running the clinical trial?

Spark Biomedical, Inc.Lead Sponsor
8 Previous Clinical Trials
527 Total Patients Enrolled
Carlos Tirado, MDStudy ChairMedical Monitor
Melanie McWade, PhDStudy DirectorSenior Director of Clinical Operations
1 Previous Clinical Trials
10 Total Patients Enrolled
~13 spots leftby Mar 2025
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