Personalized adaptive deep brain stimulation for severe opioid use disorder

Individualized Adaptive Deep Brain Stimulation in Opioid Use Disorder

This study will test whether personalized deep brain stimulation guided by invasive brain mapping is safe and can reduce cravings and opioid use in adults with severe, treatment-resistant opioid use disorder.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 6 (estimated)
• Ages: 22 Years to 75 Years
• Sex: All
• Sponsor: University of California, San Francisco (Academic / other)
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT07214467 on ClinicalTrials.gov

What this trial studies

Adults with severe, treatment-resistant opioid use disorder will be implanted with investigational deep brain stimulation devices. Investigators will perform invasive brain mapping to customize adaptive stimulation settings for each participant. Safety, craving levels, and opioid use will be tracked through regular follow-up visits and outcome measures. Device recordings will also be analyzed to improve understanding of the brain mechanisms involved in opioid use disorder.

Who should consider this trial

Good fit: Adults aged 22–75 with severe primary OUD for more than five years who have not achieved sustained remission after at least three treatment attempts, including at least one medication for OUD, are the intended candidates.

Not a fit: Patients with milder OUD, those who have not tried standard treatments, or individuals unwilling or medically unfit for brain surgery are unlikely to benefit from this invasive experimental approach.

Why it matters

Potential benefit: If successful, personalized adaptive DBS could reduce cravings and opioid use and offer a new treatment option for people who have not benefited from standard care.

How similar studies have performed: Use of DBS for addiction is largely experimental with only limited case reports and small pilots showing mixed results, so personalized adaptive DBS for OUD remains largely unproven.

Eligibility criteria

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.

Where this trial is running

San Francisco, California

• University of California, San Francisco — San Francisco, California, United States (Recruiting)

Study contacts

• Principal investigator: Khaled Moussawi, MD, PhD — University of California, San Francisco
• Study coordinator: Catherine Borror, BS

Conditions Substance Use Disorder; Opioid Use Disorder; Opioid; SUD; OUD; Substance Use; Addiction; Opioid Use