Individualized Adaptive Deep Brain Stimulation in Opioid Use Disorder (aDBS OUD)

October 25, 2025 updated by: Khaled Moussawi, MD, PhD, University of California, San Francisco
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will enroll individuals with severe Opioid Use Disorder (OUD) who have not responded to standard treatments. The devices used in this study are investigational, which means they are not approved by the Food and Drug Administration (FDA) to treat OUD. The information we obtain in this study will be used to better understand the mechanisms of OUD in the brain.

Study Type

Interventional

Enrollment (Estimated)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sierra Brandts, BS
  • Phone Number: 415-514-6551
  • Email: TN2Lab@ucsf.edu

Study Contact Backup

  • Name: Catherine Borror, BS
  • Phone Number: 415-514-6551
  • Email: TN2Lab@ucsf.edu

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California, San Francisco
        • Sub-Investigator:
          • Edward Chang, MD
        • Sub-Investigator:
          • Andrew Krystal, MD
        • Principal Investigator:
          • Khaled Moussawi, MD, PhD
        • Contact:
        • Sub-Investigator:
          • Kristin Sellers, PhD
        • Contact:
        • Sub-Investigator:
          • Philip Star, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: Deep Brain Stimulation
An individualized aDBS protocol will be used to examine therapeutic effect.
Other Names:
  • DBS
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.
Device: Deep Brain Stimulation
An individualized aDBS protocol will be used to examine therapeutic effect.
Other Names:
  • DBS
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.
Device: Deep Brain Stimulation
An individualized aDBS protocol will be used to examine therapeutic effect.
Other Names:
  • DBS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events during sEEG phase
Time Frame: Up to 2 weeks during sEEG phase.
To assess the safety of sEEG mapping in patients with severe and refractory OUD.
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.
To assess the safety of aDBS in patients with severe and refractory OUD.
Up to 16 months from time of DBS implantation.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sEEG Mapping: Brain mapping
Time Frame: Up to 2 weeks during sEEG phase.
To identify individualized brain targets for sensing neural biomarkers of craving and stimulation to mitigate craving.
Up to 2 weeks during sEEG phase.
Opioid use duirng aDBS treatment
Time Frame: Up to 16 months from time of DBS implantation.
To evaluate the preliminary efficacy of individualized aDBS in patients with severe and refractory OUD by measuring the effects of aDBS on opioid use measured with TLFB.
Up to 16 months from time of DBS implantation.
Overall functioning duirng aDBS treatment
Time Frame: Up to 16 months from time of DBS implantation.
To evaluate the preliminary efficacy of individualized aDBS in patients with severe and refractory OUD by measuring the effects of aDBS on quality of life measured with SF-36.
Up to 16 months from time of DBS implantation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Khaled Moussawi, MD, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2025

Primary Completion (Estimated)

November 22, 2031

Study Completion (Estimated)

November 22, 2031

Study Registration Dates

First Submitted

September 25, 2025

First Submitted That Met QC Criteria

October 2, 2025

First Posted (Estimated)

October 9, 2025

Study Record Updates

Last Update Posted (Estimated)

October 28, 2025

Last Update Submitted That Met QC Criteria

October 25, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-43357

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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