Deep brain stimulation to reduce drinking and craving in severe alcohol use disorder
Official title: Deep Brain Stimulation for Disorders of Addiction: Mechanisms and a Pilot Blinded Randomized Cross-over Placebo Controlled Trial
Run by University of Cambridge · NCT07341230 · Data updated 2026-11-12
This trial will test whether deep brain stimulation can safely reduce drinking and cravings in adults with severe, treatment‑resistant alcohol use disorder.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 9 (estimated) |
| Sponsor | University of Cambridge Academic / other |
| Locations | 2 sites (Cambridge, Cambridgeshire and 1 other locations) |
| Status | Recruiting |
| Started | July 1, 2025 |
| Main results expected | October 31, 2027 |
| Study ends | October 31, 2027 |
| Registry record updated | March 24, 2026 |
| Trial ID | NCT07341230 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–60 with severe, treatment‑refractory Alcohol Use Disorder of at least five years' duration who have failed standard psychotherapy and pharmacotherapy, have had three or more unsuccessful attempts at abstinence, and are medically and neurologically suitable for surgery and MRI are the intended candidates.
✕Probably not a fit
People with milder AUD, active suicidal ideation, severe psychiatric disorders such as schizophrenia or bipolar disorder, or who are not suitable for brain surgery or MRI are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot interventional study implants electrodes in two brain targets (nucleus accumbens and ventral internal capsule) to modulate circuits linked to craving, emotion, and self‑control. Participants undergo an open‑label optimization phase followed by a randomized, blinded crossover comparing dual‑site, single‑site, and sham stimulation. Primary outcomes are changes in drinking frequency and quantity, while intracranial recordings of local field potentials will be used to identify brain‑signal patterns associated with craving and relapse. The design is intended to both test clinical effect and generate neurophysiologic biomarkers to guide future adaptive neuromodulation approaches for addiction.
Why it matters
Potential benefit: If successful, this approach could reduce how often and how much people with treatment‑resistant AUD drink and offer a new therapeutic option for those who have not responded to standard care.
How similar studies have gone: DBS is established for movement disorders and OCD and small, early studies and case reports have suggested potential benefit for substance addictions, but dual‑target DBS for AUD remains novel and evidence is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Cambridge University Hospitals (Addenbrooke's Hospital)
Cambridge, Cambridgeshire, United Kingdom Recruiting -
King's College Hospital
London, Greater London, United Kingdom Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.