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Active treatment for Opioid Use Disorder (PROUD Trial)

N/A
Waitlist Available
Led By Ellen Principal Investigator
Research Sponsored by Theranova, L.L.C.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 weeks

Summary

This trial looks at whether a nerve stimulator can help with opioid withdrawal, craving, and use for people with opioid use disorder who are starting treatment with buprenorphine/naloxone.

Eligible Conditions
  • Opioid Use Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 weeks 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
Opioid craving intensity
Secondary study objectives
Withdrawal Symptoms
Opioid use
Subjective opioid withdrawal scale (SOWS). The SOWS is an 16-item, self-reported questionnaire that measures a patient's withdrawal symptoms. The SOWS has a minimum score of 0 (no withdrawal) and a maximum score of 64 (severe withdrawal).
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active treatmentExperimental Treatment1 Intervention
Participants will self-administer treatment with the Empower device at the active treatment anatomic location once daily for three weeks. Participants will complete daily and weekly surveys to evaluate the effects of the Empower active treatment.
Group II: Sham treatmentPlacebo Group1 Intervention
Participants will self-administer treatment with the Empower device at the sham treatment anatomic location once daily for three weeks. Participants will complete daily and weekly surveys to evaluate the effects of the Empower sham treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Empower Neuromodulation System
2019
N/A
~30

Find a Location

Who is running the clinical trial?

Theranova, L.L.C.Lead Sponsor
12 Previous Clinical Trials
499 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,586 Previous Clinical Trials
3,328,520 Total Patients Enrolled
Northern California Institute of Research and EducationOTHER
29 Previous Clinical Trials
10,362 Total Patients Enrolled
~2 spots leftby Nov 2025
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