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Individualized Adaptive Deep Brain Stimulation for Opioid Use Disorder

This study is looking into whether a personalized type of Deep Brain Stimulation (DBS) can safely help people with severe Opioid Use Disorder (OUD) who haven't found success with other treatments. DBS involves placing a device in the brain to send electrical signals. Researchers want to see if this individualized approach can reduce cravings and opioid use. You might be able to join if you are 22 to 75 years old, have a severe OUD diagnosis for at least 5 years, and are actively seeking treatment. The main goals are to track any side effects during the initial brain mapping phase (up to 2 weeks) and during the DBS treatment phase (up to 16 months). The study is currently unclear on its recruitment status and plans to enroll 6 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It involves a small number of participants (6 planned enrollment).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track adverse events during the sEEG phase for up to 2 weeks, and during the aDBS phase for up to 16 months from the time of DBS implantation.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07214467

Individualized Adaptive Deep Brain Stimulation in Opioid Use Disorder

Recruiting
NAAges 22–75InterventionalTreatment
University of California, San Francisco
~6 participants
Updated 2025-10-28 on ClinicalTrials.gov
What's tested:Deep Brain Stimulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events during sEEG phase
Measured over Up to 2 weeks during sEEG phase.
+1 more outcome measured

Conditions

Substance Use Disorder (SUD)
Opioid Use Disorder (OUD)

Explore related trials

Opioid Use Disorder

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Khaled Moussawi, MD, PhD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

Who to contact

Catherine Borror, BS
[email protected]
415-514-6551
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adults (all genders) 22 to 75 years old.
Current diagnosis of severe primary opioid use disorder (OUD) (\>= 6 on DSM-5 OUD criteria) (any form of opioid use).
History of opioid use for more than 5 years.
Participants are seeking treatment for their OUD.
Participants have insight into their opioid use disorder (score \> 26 on the recognition subscale of the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES V.8))
OUD is treatment refractory: unable to achieve sustained remission over the past 5 years, despite at least three treatment attempts (outpatient, residential, inpatient), with at least one treatment attempt involving taking a first-line medication for OUD (MOUD) such as buprenorphine, methadone, or extended-release naltrexone. Treatment failure is defined as continued opioid use or relapse during or after completion of treatment. Sustained remission is defined per DSM-5 as not meeting any OUD criteria except craving for \> 12 months. Documented adherence: participants must have documented adherence to the failed first-line MOUD for at least 8 weeks (PMID: 29083570).
Stated willingness to comply with all study procedures and availability for the duration of the study.
Social support system and stable living arrangement to provide assurances that the subject will adhere to study requirements: family or friends who live with or near the subject, and can provide collateral information, monitor the subject's behavior, support, and encourage the subject to participate in follow-up visits and evaluations.
For individuals of reproductive potential: use of highly effective contraception for at least 4 weeks prior to sEEG surgery and agreement to use such a method during study participation.

Exclusion

Pregnancy or lactation.
Non-English speaking.
Participants are not willing to start MOUD treatment with buprenorphine or to switch MOUD to buprenorphine if they are already on other MOUD, for the duration of the study.
OUD treatment with another investigational drug or other intervention within 3 months.
History of primary psychosis or Bipolar I disorder per the medical interview.
History of severe personality disorder that could interfere with study participation (e.g., antisocial personality disorder) per the medical interview.
History of traumatic brain injury with loss of consciousness greater than 5 minutes.
Clinically significant cognitive impairment per neuropsychological testing.
History of suicidal attempts in the past 3 years or current suicidal thoughts per psychiatric evaluation.
Coagulopathy: INR \> 1.4, aPTT \> 40 s, platelets \< 100,000.
Current clinically significant medical or neurologic disease that affects brain function (e.g., recent stroke, myocardial infarction, seizures not due to alcohol withdrawal).
Clinically significant abnormality on structural brain MRI scan.
Life expectancy less than 24 months per the clinical judgment of study investigators (e.g., terminal cancers).
Any labeled DBS contraindication or inability to have brain MRI: certain pacemakers, metal in body, inability to undergo awake operation, significant cardiac or other medical risk factors for surgery, infection, and coagulopathy.
Exclusion for early remission: participants who achieve early remission after initiating buprenorphine during the screening phase (prior to the sEEG phase) will be excluded from the study.

What this trial measures

  • Incidence of adverse events during sEEG phaseUp to 2 weeks during sEEG phase.

    To assess the safety of sEEG mapping in patients with severe and refractory OUD.

  • Incidence of adverse events during aDBS phaseUp to 16 months from time of DBS implantation.

    To assess the safety of aDBS in patients with severe and refractory OUD.