Brain pacemaker could curb alcohol cravings in severe addiction
NCT ID NCT07341230
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether deep brain stimulation (DBS) can safely reduce drinking in people with severe alcohol use disorder who haven't improved with standard treatments. DBS uses implanted electrodes to send small electrical signals to brain areas linked to craving and self-control. Nine adults will receive DBS and be monitored for changes in drinking habits and cravings over several months.
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 offer a new treatment option for people with severe alcohol addiction who haven't improved with standard therapies.
- What could go wrong
- This is a very small, early pilot study with only 9 participants, so results may not apply widely. DBS involves brain surgery, which 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 9 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Oct 2027
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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18 to 60 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 aged 18 to 60 years * Diagnosed with Alcohol Use Disorder (AUD) according to DSM-5 criteria * Primary diagnosis of treatment-refractory AUD (comorbid nicotine dependence, other psychoactive substance use disorders, moderate major depressive disorder, anxiety disorders or obsessive-compulsive disorder are permissible if AUD is principal) * Disorder duration of AUD ≥ 5 years * At least 3 unsuccessful attempts at achieving abstinence * Failed prior psychotherapy and standard pharmacotherapy for AUD * Medically and neurologically suitable for surgery and MRI-compatible * Capable of providing informed consent and willing to comply with study procedures Exclusion Criteria: * Severe psychiatric disorder other than Alcohol Use Disorder (e.g., schizophrenia, schizoaffective disorder, bipolar disorder) * Severe major depressive disorder (moderate depression acceptable) * Current active suicidal ideation or history of serious suicide attempts * Previous treatment with electroconvulsive therapy (ECT) * Presence of implanted electrical devices, including: * Cardiac pacemaker or defibrillator (or clinical indication for pacemaker placement) * Implanted vagus nerve stimulator (VNS) * Any other chronically implanted neurostimulation device * Significant neurological history, including prior hemorrhagic or ischemic stroke, subarachnoid hemorrhage, or other major neurological illness * Any significant medical condition that, in the opinion of the clinical team, would increase surgical or anesthetic risk * Current pregnancy * Contraindications to deep brain stimulation or neurosurgery, including: * Inability to tolerate general anesthesia (as assessed by anesthesiology) * Increased risk of bleeding (as determined by hepatology/hematology review) * History of coagulopathy * Current or previous anticoagulant use * Uncontrolled hypertension (controlled hypertension with medication is acceptable) * Stage 4 liver cirrhosis * History of major cardiac arrhythmia (e.g., atrial fibrillation) or need for anti-arrhythmic medication * History of requiring cardioversion * History of repeated falls * History of major head injury * Marked cognitive impairment * Seizure history, including multiple alcohol withdrawal seizures * Marked cortical atrophy on neuroimaging * Inadequate logistical or social support that would impair the safe conduct of deep brain stimulation therapy, including inability to reliably attend scheduled visits, lack of reasonable access to the study site, or inadequate home or caregiver support necessary for postoperative care, device management and follow-up.
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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 study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
2 sites. 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
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Locations
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Cambridge University Hospitals (Addenbrooke's Hospital)
RECRUITINGCambridge, Cambridgeshire, CB2 0QQ, United Kingdom
Contact Email: •••••@•••••
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King's College Hospital
RECRUITINGLondon, Greater London, SE5 9RS, United Kingdom
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