Dual-target deep brain stimulation for treating severe alcohol use disorder

Efficacy and Safety of Dual-target Deep Brain Stimulation for Treatment-resistant Alcohol Use Disorder: a Multi-center, Single Arm, Prospective, Open-label, Extendable Study.

This study is testing if a new brain stimulation treatment can help people with severe alcohol use disorder who haven't had success with other treatments.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Second Xiangya Hospital of Central South University (other)
• Locations: 4 sites (Changsha, Hunan and 3 other locations)
• Trial ID: NCT05884619 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of dual-target deep brain stimulation (DBS) for patients with treatment-resistant alcohol use disorder. A total of 12 participants will undergo neurosurgical implantation of DBS targeting the bilateral nucleus accumbens and anterior limb of internal capsule. The stimulation will be activated and adjusted within two weeks post-implantation, with efficacy and safety assessments conducted over a period of 9 to 32 weeks. Key efficacy indicators include rates of heavy drinking and days of alcohol abstinence, while safety will be monitored through adverse events and device-related complications.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with a long history of alcohol use disorder and multiple failed attempts to quit drinking.

Not a fit: Patients with other serious mental disorders or those with additional substance use disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option for individuals struggling with severe alcohol use disorder who have not responded to traditional therapies.

How similar studies have performed: While this approach is novel, similar studies exploring deep brain stimulation for addiction have shown promising results, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. 18 to 65 years old, no limit on sex.
2. Meet The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for alcohol use diagnosis with more than 4 positive items.
3. Course of alcohol use disorder ≥ 3 years.
4. Had at least 3 failed quit drinking experiences (de-addiction treatment under medical conditions, quit drinking by oneself, quit drinking each time ≥ 1 week)
5. Patient and relatives agree to accept systemic treatment of this study and sign Informed Consent Form after study purpose, content, expected treatment and risk etc. are fully explained and understood.

Exclusion Criteria:

1. Patients with other serious mental disorders (e.g. schizophrenia spectrum, depression disorder, biphasic or related disorder, etc. )
2. Patients who have other substance (other than tobacco) use disorders.
3. During screening period, answered 'yes' on question 4 or 5 in suicide intention term from Columbia-Suicide Severity Rating Scale, or had significant suicidal ideations in the past 3 months, or patients who are considered by researchers to have suicide or violence risks.
4. Patients who have serious or unstable cardiovascular, respiratory, liver, kidney, hematological, endocrine, nervous system or other systemic diseases.
5. Patients who have implanted cochlear, pacemaker, cardiac defibrillator, single-sided or double-sided products of the same category, or the investigator evaluates patients have done surgeries within 6 months that can affect this study.
6. HIV positive patients.
7. Woman at pregnant or lactation period, or childbearing age woman test positive for human chorionic gonadotropin (HCG)/urine pregnancy check; or patients who can't take effective contraception measures during trial; or patients who plan to be/make pregnant 3 months after the trial starts.
8. Patients who are participating other pharmaceutical or medical device clinical trials or have participated one in the past 3 months.
9. Patients who are considered unsuitable by investigators.

Where this trial is running

Changsha, Hunan and 3 other locations

• Second Xiangya Hospital of Central South University — Changsha, Hunan, China (RECRUITING)
• Shanghai Mental Health Center — Shanghai, Shanghai, China (RECRUITING)
• Huashan Hospital — Shanghai, Shanghai, China (RECRUITING)
• Shanghai 6th People's Hospital — Shanghai, Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Wei Hao

Conditions: Alcohol Use Disorder, Deep Brain Stimulation, Alcoholism, Alcohol Drinking, Drinking Behavior, Alcohol-Related Disorders, Substance-Related Disorders, Chemically-Induced Disorders