NCT07341230 Deep Brain Stimulation to Understand and Treat Addiction
| NCT ID | NCT07341230 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Cambridge |
| Condition | Alcohol Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 9 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 9 participants in total. It began in 2025-07-01 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is testing whether deep brain stimulation (DBS) can safely help people with severe alcohol use disorder who have not improved with standard treatments. DBS uses small electrical signals to change activity in brain areas linked to craving, self-control, and emotion. The study will test whether this treatment can reduce how often people drink and how much they drink each day. Researchers will also record brain activity to better understand how DBS affects craving and relapse.
Eligibility 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.
Frequently Asked Questions
Who can join the NCT07341230 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Alcohol Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07341230 currently recruiting?
Yes, NCT07341230 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Cambridge to inquire about joining.
Where is the NCT07341230 trial being conducted?
This trial is being conducted at Cambridge, United Kingdom, London, United Kingdom.
Who is sponsoring the NCT07341230 clinical trial?
NCT07341230 is sponsored by University of Cambridge. The trial plans to enroll 9 participants.