Alcohol Use DisorderNCT05884619
Efficacy and Safety of Dual-target Deep Brain Stimulation for Treatment-resistant Alcohol Use Disorder
A study testing Dual-target deep brain stimulation in people with Alcohol Use Disorder and Deep Brain Stimulation, run by Second Xiangya Hospital of Central South University at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Use Disorder, Deep Brain Stimulation
- What is being tested?
- Dual-target deep brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 4 sitesChina
- Study dates
- 14 Aug 2023to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Wei Hao, +8613907484086, weihao57@163.com
Wei Hao
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Min Zhao, +8618017311005, drminzhao@gmail.com
Min Zhao
- Recruiting
Huashan Hospital
Shanghai, Shanghai Municipality, 200040
Liang Chen, +8613661882460
Liang Chen
- Recruiting
Shanghai 6th People's Hospital
Shanghai, Shanghai Municipality, 200233
Wanhai Ding, +8618930170125
Wanhai Ding
About this study
Official title: 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 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.
Read the detailed description
Total of 12 subjects from two centers ( Shanghai Mental Health Center and The Second Xiangya Hospital of Central South University ) who meet inclusion and don't meet exclusion criteria are recruited to undergo neurosurgical implantation of dual-target DBS in bilateral nucleus accumbens (NAcc) and anterior limb of internal capsule (ALIC) on Day 0. The DBS system will be turned on for stimulation and parameter adjustment will be conducted on day 10-14 after implantation. The efficacy and safety evaluation will be conducted in 9-32 weeks after implantation. The indicators on efficacy are heaving drinking rate, uncontrolled alcohol consumption days, maximum consecutive alcohol abstinent days. The indicators for safety are adverse events (AE) and device related AE, serious adverse events (SAE) and device related SAE, device deficiencies (DD) and device malfunction, physical examination and vital signs, laboratory examination, ECG, imaging examination, scale evaluation and early drop out ratio due to AE.
- Conditions
- Alcohol Use Disorder, Deep Brain Stimulation
- Being tested
- Dual-target deep brain stimulation
- Keywords
- Alcoholism, Alcohol Drinking, Drinking Behavior, Alcohol-Related Disorders, Substance-Related Disorders, Chemically-Induced Disorders, Mental Disorders
- Medical subject headings
- Alcoholism, Alcohol Drinking, Drinking Behavior, Alcohol-Related Disorders, Substance-Related Disorders, Chemically-Induced Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Dual-target deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9-32 weeks of stimulation
Cumulated uncontrolled alcohol use days
Total days of all uncontrolled alcohol use days throughout 24 weeks
- Definition: more than 3 times consecutive alcohol use (random draw) ≥ 5 standard cups
- 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
- Cumulated uncontrolled alcohol use days: Total days of all uncontrolled alcohol use days throughout 24 weeks
Measured: 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'
Measured: 9-32 weeks of stimulation
Secondary outcomes (7)
Alcohol use volume
change in monthly average alcohol use volume compared to baseline. (Record in every follow-up according to participants. Record alcohol type, amount and experience when drinking throughout 9-32 weeks after stimulation. Increased value implies worse result and reduce of alcohol use volume indicates improvement.
Measured: 9-32 weeks after stimulation
Cumulated alcohol abstinent days
total value of 'Constant alcohol suspension' days
Measured: 9-32 weeks of stimulation.
Subjective alcohol craving
change in alcohol urge Visual Analogue Score compared to baseline. ( 0 is no urge, 10 is extreme urge)
Measured: At 12, 20 and 32 weeks of stimulation
Alcohol withdrawal scores
change in Clinical Institute Withdrawal Assessment for Alcohol Scale (CIWA-Ar) score compared to baseline. Minimum score is 0, maximum score is 67, higher the score, alcohol withdrawal is more severe (worse outcome).
Measured: At 12, 20 and 32 weeks of stimulation
Sleep status
Pittsburgh Sleep Quality Index score compared to baseline.
Measured: At 12, 20 and 32 weeks of stimulation
affect status
Hamilton Anxiety Scale-17 and Hamilton Depression Scale score compared to baseline.
Measured: At 12, 20 and 32 weeks of stimulation
Social functionings
Substance Dependence Severity Scale (SDSS) score compared to baseline. Minimum score is 0, maximum score is 20, higher the score, substance dependence is more severe (worse outcome).
Measured: At 12, 20 and 32 weeks of stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start14 Aug 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Second Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Mental Health Center, Huashan Hospital, Shanghai 6th People's Hospital, SceneRay Corporation, Limited
- Responsible party
- Principal investigator, Wei Hao, Second Xiangya Hospital of Central South University
- Investigators
- Wei Hao, Study chair, Second Xiangya Hospital of Central South UniversityMin Zhao, Study chair, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884619
- Sponsor's protocol ID
- SR1182-AUD-I
- Status last verified
- Sep 2023
- First submitted
- 23 May 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05884619
- Acronym / sponsor ID
- SR1182-AUD-I
- Conditions
- Alcohol Use Disorder, Deep Brain Stimulation
- Keywords
- Alcoholism, Alcohol Drinking, Drinking Behavior, Alcohol-Related Disorders, Substance-Related Disorders, Chemically-Induced Disorders, Mental Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- Shanghai Mental Health Center, Huashan Hospital, Shanghai 6th People's Hospital, SceneRay Corporation, Limited
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Total of 12 subjects from two centers ( Shanghai Mental Health Center and The Second Xiangya Hospital of Central South University ) who meet inclusion and don't meet exclusion criteria are recruited to undergo neurosurgical implantation of dual-target DBS in bilateral nucleus accumbens (NAcc) and anterior limb of internal capsule (ALIC) on Day 0. The DBS system will be turned on for stimulation and parameter adjustment will be conducted on day 10-14 after implantation. The efficacy and safety evaluation will be conducted in 9-32 weeks after implantation. The indicators on efficacy are heaving drinking rate, uncontrolled alcohol consumption days, maximum consecutive alcohol abstinent days. The indicators for safety are adverse events (AE) and device related AE, serious adverse events (SAE) and device related SAE, device deficiencies (DD) and device malfunction, physical examination and vital signs, laboratory examination, ECG, imaging examination, scale evaluation and early drop out ratio due to AE.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dual-target deep brain stimulation | Experimental | Device: Dual-target deep brain stimulationThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual-target deep brain stimulationDBS 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. | Device | Dual-target deep brain stimulation |
Primary outcome
Heavy drinking rate
Time frame: 9-32 weeks of stimulation
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.
Cumulated uncontrolled alcohol use days
Time frame: 9-32 weeks of stimulation
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
Maximum consecutive alcohol abstinent days
Time frame: 9-32 weeks of stimulation
Constant alcohol suspension standard: Blow test negative and no alcohol use reported over past 3 days. Marked as maximum days of 'Constant alcohol suspension'
7 secondary outcomes
Alcohol use volume
Time frame: 9-32 weeks after stimulation
Cumulated alcohol abstinent days
Time frame: 9-32 weeks of stimulation.
Subjective alcohol craving
Time frame: At 12, 20 and 32 weeks of stimulation
Alcohol withdrawal scores
Time frame: At 12, 20 and 32 weeks of stimulation
Sleep status
Time frame: At 12, 20 and 32 weeks of stimulation
affect status
Time frame: At 12, 20 and 32 weeks of stimulation
Social functionings
Time frame: At 12, 20 and 32 weeks of stimulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Hao study chair
Second Xiangya Hospital of Central South University
Min Zhao study chair
Shanghai Mental Health Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-target deep brain stimulation in people with Alcohol Use Disorder and Deep Brain Stimulation, run by Second Xiangya Hospital of Central South University at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Hao (+8613907484086, weihao57@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heavy drinking rate (time frame: 9-32 weeks of stimulation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.