Efficacy and Safety of Dual-target Deep Brain Stimulation for Treatment-resistant Alcohol Use Disorder

NCT05884619 | Unknown

• 1 other identifier: SR1182-AUD-I
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 4

Brief Summary

This is a multi-center, single arm, prospective, open-label, extendable study for the efficacy and safety of dual-target deep brain stimulation for treatment-resistant alcohol use disorder.

Conditions

Alcohol Use Disorder; Deep Brain Stimulation

Keywords

Alcoholism; Alcohol Drinking; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Outcome Measures

Primary Outcomes (3)

• Heavy drinking rate

  Calculation formula: 'major alcohol use' times / 56 (total observation times) \* 100%; a) Marked as maximum days of 'Constant alcohol suspension' b) Note: i. Major alcohol use standard: Blow test positive and reported ≥ 5 standard cups daily over the past 3 days. 1 standard cup = 10g of pure alcohol.

  9-32 weeks of stimulation

• Cumulated uncontrolled alcohol use days

  Total days of all uncontrolled alcohol use days throughout 24 weeks 1. Definition: more than 3 times consecutive alcohol use (random draw) ≥ 5 standard cups 2. One time uncontrolled alcohol use days: e.g. 3 times consecutive follow-up results ≥ 5 standard cups, fourth time \< 5 standard cups, then uncontrolled alcohol use days is 3 \* 3 = 9 days 3. Cumulated uncontrolled alcohol use days: Total days of all uncontrolled alcohol use days throughout 24 weeks

  9-32 weeks of stimulation

• Maximum consecutive alcohol abstinent days

  Constant alcohol suspension standard: Blow test negative and no alcohol use reported over past 3 days. Marked as maximum days of 'Constant alcohol suspension'

  9-32 weeks of stimulation

Secondary Outcomes (7)

• Alcohol use volume

  9-32 weeks after stimulation

• Cumulated alcohol abstinent days

  9-32 weeks of stimulation.

• Subjective alcohol craving

  At 12, 20 and 32 weeks of stimulation

• Alcohol withdrawal scores

  At 12, 20 and 32 weeks of stimulation

• Sleep status

  At 12, 20 and 32 weeks of stimulation

Other Outcomes (3)

• Electrophysiology indicators

  Before stimulation and parameter optimization period

• Incidence of adverse events and related data

  Collect security data throughout the research period, including AE, SAE, etc.

• Positron Emission Topography imaging indicators

  Before stimulation and parameter optimization period

Study Arms (1)

Dual-target deep brain stimulation

EXPERIMENTAL

This is a single arm, prospective, open label clinical study, participants who fit inclusion and don't fit exclusion criteria, completed physical anti-addiction treatments and surgical implantation standard will start DBS system stimulation and adjust parameters after 10-14 days of implantation. Then after stimulation for 9-32 weeks, they will be evaluated for treatment efficacies. This study is extendable, with agreements from participants, long term efficacy and safety follow-up study will be performed after 32 weeks ± 7 days of following, once every 2-3 months.

Device: Dual-target deep brain stimulation

Interventions

Dual-target deep brain stimulation DEVICE

DBS electrodes will be implanted into the ALIC and the NAcc, electric stimulation of those areas are used to treat alcohol use disorder and to evaluate the efficacy and safety of DBS system.

Dual-target deep brain stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 65 years old, no limit on sex.
• Meet The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for alcohol use diagnosis with more than 4 positive items.
• Course of alcohol use disorder ≥ 3 years.
• Had at least 3 failed quit drinking experiences (de-addiction treatment under medical conditions, quit drinking by oneself, quit drinking each time ≥ 1 week)
• 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.

You may not qualify if:

• Patients with other serious mental disorders (e.g. schizophrenia spectrum, depression disorder, biphasic or related disorder, etc. )
• Patients who have other substance (other than tobacco) use disorders.
• 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.
• Patients who have serious or unstable cardiovascular, respiratory, liver, kidney, hematological, endocrine, nervous system or other systemic diseases.
• 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.
• HIV positive patients.
• 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.
• Patients who are participating other pharmaceutical or medical device clinical trials or have participated one in the past 3 months.
• Patients who are considered unsuitable by investigators.

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead
• Shanghai Mental Health Center: collaborator
• Huashan Hospital: collaborator
• Shanghai 6th People's Hospital: collaborator
• SceneRay Corporation, Limited: collaborator

Study Sites (4)

Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

RECRUITING

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Shanghai 6th People's Hospital

Shanghai, Shanghai Municipality, 200233, China

RECRUITING

MeSH Terms

Conditions

Alcoholism; Alcohol Drinking; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Wei Hao

  Second Xiangya Hospital of Central South University

  STUDY CHAIR

• Min Zhao

  Shanghai Mental Health Center

  STUDY CHAIR

Central Study Contacts

Wei Hao

CONTACT

+8613907484086; weihao57@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 1, 2023
• Study Start: August 14, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)