NCT05786872

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 28, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

July 5, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

August 1, 2023

Status Verified

January 1, 2023

Enrollment Period

1.5 years

First QC Date

February 26, 2023

Last Update Submit

July 28, 2023

Conditions

Alcohol Use DisorderDeep Brain Stimulation

Outcome Measures

Primary Outcomes (3)

  • Major alcohol use rate

    Calculation formula: 'major alcohol use' times / 56 (total observation times) \* 100%

    24 weeks

  • Cumulated uncontrolled alcohol use days

    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

    24 weeks

  • Maximum consecutive alcohol suspension days

    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. ii. Minor alcohol use standard: No matter blow test is positive or not, alcohol use is reported over past 3 days but less than 5 standard cups. iii. Constant alcohol suspension standard: Blow test negative and no alcohol use reported over past 3 days.

    24 weeks

Secondary Outcomes (7)

  • Alcohol use volume

    24 weeks

  • Cumulated alcohol suspension days

    24 weeks

  • Subjective alcohol urge

    At 12, 20 and 32 weeks of stimulation

  • Alcohol abstinence

    At 12, 20 and 32 weeks of stimulation

  • Sleep condition

    At 12, 20 and 32 weeks of stimulation

  • +2 more secondary outcomes

Other Outcomes (3)

  • Brain electrophysiology study（electroencephalogram）

    Before stimulation and parameter optimization period(1-8 weeks after stimulation)

  • Brain electrophysiology study（Local Field Potentials）

    Before stimulation and parameter optimization period(1-8 weeks after stimulation)

  • PET-CT

    Before DBS implant, after 6 months of implant.

Study Arms (1)

dual-target deep brain stimulation

EXPERIMENTAL

This is a single arm, prospective, open label clinical study, participants who fit inclusion/exclusion standards, 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 stimulationDEVICE

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

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 65 years old, no limit on sex.
  • Qualifies DSM-5 definition of alcohol use diagnosis, at least more than 4 terms.
  • Course of alcohol use disorder ≥ 3 years.
  • Tried to quit drinking (de-addiction treatment under medical conditions, quit drinking by oneself, quit drinking each time ≥ 1 week) but failed ≥ 3 times.
  • 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 who qualify DSM-5 serious mental disorder diagnosis standard (e.g. Schizophrenia spectrum, depression disorder, biphasic or related disorder, etc. )
  • Patients who have other substance (tobacco excluded) abuse.
  • During screening period, answered 'yes' on question 4 or 5 in suicide intention term from Columbia-Suicide Severity Rating Scale, or had significant suicide intentions 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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Second Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

RECRUITING

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Min Zhao

    Shanghai Mental Health Center

    STUDY CHAIR

Central Study Contacts

Min Zhao

CONTACT

64387250drminzhao@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2023

First Posted

March 28, 2023

Study Start

July 5, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

August 1, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)