Deep Brain Stimulation to Understand and Treat Addiction
Key facts
- Who runs it
- University of Cambridge
- Where
- United Kingdom2 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- People taking part
- 9 people, planned
- Started
- 1 Jul 2025
- Expected to end
- 31 Oct 2027
- Type of study
- Interventional, 4 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Dual-Target Deep Brain Stimulation
- Nucleus Accumbens Deep Brain Stimulation
- Ventral Internal Capsule Deep Brain Stimulation
- Sham Deep Brain Stimulation
- Record updated
- 24 March 2026
Who can take part
- Age
- 18 years to 60 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 34 criteriaShow less
Who can take part
- 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
Who cannot take part
- Previous treatment with electroconvulsive therapy (ECT)
- Significant neurological history, including prior hemorrhagic or ischemic stroke, subarachnoid hemorrhage, or other major neurological illness
- Current or previous anticoagulant use
- 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
- 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
- Cardiac pacemaker or defibrillator (or clinical indication for pacemaker placement)
- Any significant medical condition that, in the opinion of the clinical team, would increase surgical or anesthetic risk
- Increased risk of bleeding (as determined by hepatology/hematology review)
- History of coagulopathy
- Uncontrolled hypertension (controlled hypertension with medication is acceptable)
- 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
- Presence of implanted electrical devices, including:
- Implanted vagus nerve stimulator (VNS)
- Any other chronically implanted neurostimulation device
- Current pregnancy
- Contraindications to deep brain stimulation or neurosurgery, including:
- Inability to tolerate general anesthesia (as assessed by anesthesiology)
- Stage 4 liver cirrhosis
- Marked cortical atrophy on neuroimaging
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 4 groups in the trial
- Dual Stimulation (Nucleus Accumbens + Ventral Internal Capsule)Treatment being tested
Participants receive active deep brain stimulation simultaneously targeting both the nucleus accumbens and the ventral internal capsule.
Treatment: Dual-Target Deep Brain Stimulation
- Single Stimulation - Nucleus Accumbens OnlyExisting treatment, for comparison
Participants receive active deep brain stimulation targeting the nucleus accumbens only, with ventral internal capsule stimulation inactive.
Treatment: Nucleus Accumbens Deep Brain Stimulation
- Single Stimulation - Ventral Internal Capsule OnlyExisting treatment, for comparison
Participants receive active deep brain stimulation targeting the ventral internal capsule only, with nucleus accumbens stimulation inactive.
Treatment: Ventral Internal Capsule Deep Brain Stimulation
- Sham Stimulation (Inactive)Sham treatment, for comparison
Participants receive sham (inactive) deep brain stimulation. The implanted device is turned off; no therapeutic stimulation is provided.
Treatment: Sham Deep Brain Stimulation
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Deep Brain Stimulation for Disorders of Addiction: Mechanisms and a Pilot Blinded Randomized Cross-over Placebo Controlled Trial
- Fit questions
- Built from NCT07341230, who can take part
- Record updated
- 24 March 2026