Clinical trial for Alcohol Use Disorder
Official title Deep Brain Stimulation to Understand and Treat Addiction
ClinicalTrials.gov ID: NCT07341230
What this study is testing
- What it's testing
- The study wants to see if deep brain stimulation can safely reduce how often and how much people drink, and to learn how it changes brain activity related to craving and relapse.
- Who it's for
- It is looking for adults with severe alcohol use disorder who have not responded to standard treatments.
- What's involved
- Participants will receive deep brain stimulation, have brain activity recorded, and report their drinking habits during the study.
- Time commitment
- The study lasts several months and involves regular clinic visits for stimulation adjustments and monitoring.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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 duration of AUD ≥ 5 years
- At least 3 unsuccessful attempts at achieving abstinence
You likely can't join if
- 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)
- Cardiac pacemaker or defibrillator (or clinical indication for pacemaker placement)
- Implanted vagus nerve stimulator (VNS)
See the full eligibility 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...
- 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
- 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)
- 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
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Cambridge, Cambridgeshire, United Kingdom
- London, Greater London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Cambridge, Cambridgeshire, United Kingdom; London, Greater London, United Kingdom. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.