Brain pacemaker aims to curb opioid cravings
NCT ID NCT07214467
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This early study tests whether personalized deep brain stimulation (DBS) can safely reduce cravings and opioid use in 6 adults with severe, treatment-resistant opioid use disorder. Researchers will first map brain activity to find each person's craving signals, then deliver targeted stimulation. The main goal is safety, with a preliminary look at whether it helps.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Deep brain stimulation (DBS) device
- What this could lead to
- If it works, this could point toward a new brain-based treatment for people with severe opioid addiction who haven't improved with other therapies.
- What could go wrong
- This is a very early, tiny study (only 6 people) focused on safety first. It may not reduce opioid use, and brain surgery carries risks like infection or bleeding.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 6 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Nov 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of California, San Francisco
RECRUITINGSan Francisco, California, 94143, United States
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