Last updated: July 28, 2023
Sponsor: Shanghai Mental Health Center
Overall Status: Active - Recruiting
Phase
N/A
Condition
Addictions
Alcohol Dependence
Substance Abuse
Treatment
dual-target deep brain stimulation
Clinical Study ID
NCT05786872
MZhao-012
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 18 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 drinkingby oneself, quit drinking each time ≥ 1 week) but failed ≥ 3 times.
- Patient and relatives agree to accept systemic treatment of this study and signInformed Consent Form after study purpose, content, expected treatment and risk etc.are fully explained and understood.
Exclusion
Exclusion Criteria:
- 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 termfrom Columbia-Suicide Severity Rating Scale, or had significant suicide intentions inthe past 3 months, or patients who are considered by researchers to have suicide orviolence 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-sidedor double-sided products of the same category, or the investigator evaluates patientshave 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 forHCG/urine pregnancy check; or patients who can't take effective contraception measuresduring trial; or patients who plan to be/make pregnant 3 months after the trialstarts.
- Patients who are participating other pharmaceutical or medical device clinical trialsor have participated one in the past 3 months.
- Patients who are considered unsuitable by investigators.
Study Design
Total Participants: 12
Treatment Group(s): 1
Primary Treatment: dual-target deep brain stimulation
Phase:
Study Start date:
July 05, 2023
Estimated Completion Date:
December 31, 2024
Study Description
Connect with a study center
Second Xiangya Hospital of Central South University
Changsha, Hunan 410000
ChinaActive - Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai 200000
ChinaActive - Recruiting
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