Recruiting

Deep Brain Stimulation

Sponsor:

UCLA

Code:

NCT07214467

Conditions

Substance Use Disorder (SUD)

Opioid Use Disorder (OUD)

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Interventions

Deep Brain Stimulation

Study Details

Brief summary:

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

Substance Use Disorder (SUD)

Opioid Use Disorder (OUD)

Study ID

NCT07214467

Start date

Oct 24, 2025

Status verified date

Oct, 2025

Completion date

Nov 22, 2031

Anticipated

Primary completion date

Nov 22, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

6 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: aDBS / cDBS / sham Stimulation

Participants in this group will first receive adaptive deep brain stimulation (aDBS), followed by continuous deep brain stimulation (cDBS), and finally a sham stimulation. Each period of the randomized controlled trial (aDBS, cDBS, and sham) will last 4 months.

other: sham / aDBS / cDBS

Participants in this group will first receive sham stimulation, followed by adaptive deep brain stimulation (aDBS), and finally continuous deep brain stimulation (cDBS). Each period of the randomized controlled trial (aDBS, cDBS, and sham) will last 4 months.

other: cDBS / sham / aDBS

Participants in this group will first receive continuous deep brain stimulation (cDBS), followed by sham stimulation, and finally adaptive deep brain stimulation (aDBS). Each period of the randomized controlled trial (aDBS, cDBS, and sham) will last 4 months.

Interventions

Deep Brain Stimulation

An individualized aDBS protocol will be used to examine therapeutic effect.

Primary outcome measure

  • Incidence of adverse events during sEEG phase [ Time Frame: Up to 2 weeks during sEEG phase. ]
  • Incidence of adverse events during aDBS phase [ Time Frame: Up to 16 months from time of DBS implantation. ]

Central Contacts and Locations

Central contacts

Catherine Borror, BS

415-514-6551TN2Lab@ucsf.edu

Sierra Brandts, BS

415-514-6551TN2Lab@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Catherine Borror, BS

415-514-6551TN2Lab@ucsf.edu

Sierra Brandts, BS

415-514-6551TN2Lab@ucsf.edu

Principal Investigator:

Khaled Moussawi, MD, PhD

More Information

Sponsor

University of California, San Francisco

Last update posted

Oct 28, 2025

Last verified

Oct, 2025

Keywords

  • Opioid
  • SUD
  • OUD
  • Substance Use
  • Substance Use Disorder
  • Addiction
  • Opioid Use Disorder
  • Opioid Use
  • deep brain stimulation
  • Neuromodulation
  • stereo-EEG
  • brain mapping

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2025-10-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.