Actively Recruiting

Phase Not Applicable
Age: 22Years - 75Years
All Genders
NCT07214467

Individualized Adaptive Deep Brain Stimulation in Opioid Use Disorder

Led by University of California, San Francisco · Updated on 2025-10-28

6

Participants Needed

1

Research Sites

317 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to determine if personalized (adaptive) Deep Brain Stimulation (DBS) based upon invasive brain mapping is safe and can lead to better outcomes like reductions in craving and opioid use.

CONDITIONS

Official Title

Individualized Adaptive Deep Brain Stimulation in Opioid Use Disorder

Who Can Participate

Age: 22Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 22 to 75 years, all genders
  • Current diagnosis of severe primary opioid use disorder (6 or more criteria on DSM-5)
  • History of opioid use for more than 5 years
  • Seeking treatment for opioid use disorder
  • Insight into opioid use disorder (score above 26 on SOCRATES recognition subscale)
  • Treatment refractory: no sustained remission over 5 years despite at least 3 treatment attempts including first-line medication for OUD (buprenorphine, methadone, or extended-release naltrexone)
  • Documented adherence to first-line medication for at least 8 weeks
  • Willingness to comply with all study procedures and availability for study duration
  • Stable social support and living arrangement to ensure adherence and follow-up
  • For people of reproductive potential, use of highly effective contraception for at least 4 weeks before sEEG surgery and agreement to continue during study
Not Eligible

You will not qualify if you...

  • Pregnancy or lactation
  • Non-English speaking
  • Unwilling to start or switch to buprenorphine treatment during the study
  • Use of another investigational drug or intervention for OUD within past 3 months
  • History of primary psychosis or Bipolar I disorder
  • History of severe personality disorder interfering with participation
  • History of traumatic brain injury with loss of consciousness over 5 minutes
  • Clinically significant cognitive impairment
  • History of suicidal attempts in past 3 years or current suicidal thoughts
  • Blood clotting disorders (INR > 1.4, aPTT > 40 seconds, platelets < 100,000)
  • Current serious medical or neurological diseases affecting brain function
  • Abnormal brain MRI scan
  • Life expectancy under 24 months
  • Any contraindication to DBS or inability to have brain MRI (e.g., pacemakers, metal implants, medical risks for surgery)
  • Participants who achieve early remission after starting buprenorphine during screening phase

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of California, San Francisco

San Francisco, California, United States, 94143

Actively Recruiting

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Research Team

C

Catherine Borror, BS

CONTACT

S

Sierra Brandts, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

3

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