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The aim of this trial is to investigate the efficacy of left DLPFC iTBS in a population of alcohol use disorder patients, compared with the sham iTBS. Moreover, this trial will conduct follow-up assessments to evaluate whether its efficacy can sustain for a long time if it is effective.
Alcohol abuse and alcohol use disorder are important major health issues in our modern society. However, the treatment of alcohol addiction is currently limited to the treatment of acute withdrawal symptoms, but lacks effective interventions to reduce craving and prevent relapse. In an attempt to improve the treatment of substance dependence, non-invasive neuromodulation has gained attention as a new potential treatment option. The aim of this trial is to investigate the efficacy of left DLPFC iTBS in a population of alcohol use disorder patients, compared with the sham iTBS. Moreover, this trial will conduct follow-up assessments to evaluate whether its efficacy can sustain for a long time if it is effective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Real stimulation |
|
| Control Group | Sham Comparator | Sham stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent Theta Burst Stimulation (iTBS) | Device | The target is left DLPFC and the iTBS protocol is: 70% of RMT; triplet 50 Hz bursts, repeated at 5 Hz; 2s on and 8s off; 600 pulses a session. |
| Measure | Description | Time Frame |
|---|---|---|
| Craving change | Craving will be measured by visual analogue scale(VAS), participants specify their level of craving by indicating a position along a continuous line between two end-points, score ranges from 0 to 10, 0 refers to the lowest level of craving, 10 refers to the highest level of craving. | baseline, after the intervention, and 3 months after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| The abstinence rate after the treatment | The abstinence rate defined as the number of abstinent days in the three months after the last simulation session | after the intervention, and 3 months after the intervention |
| Change of depression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chenxin Yuan | Contact | 18616819260 | yuan_ycx@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32218749 | Derived | Yuan C, Su H, Chen T, Voon V, Du J. The Effect of Intermittent Theta Burst Stimulation (iTBS) in Patients With Alcohol Use Disorder: Study Protocol for a Randomized Controlled Trial. Front Psychiatry. 2020 Mar 10;11:210. doi: 10.3389/fpsyt.2020.00210. eCollection 2020. |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Sham stimulation | Device | The target is right DLPFC and the sham stimulation protocol is: triplet 50 Hz bursts, repeated at 5 Hz; 2s on and 8s off; 600 pulses a session. |
|
The decrease of Beck Depression Inventory (BDI) scores, a 21-question multiple-choice self-report inventory to measure the severity of depression .
| bbaseline, after the 2-weeks intervention, and 6 months after the intervention |
| Change of anxiety | The decrease of Beck Anxiety Inventory (BAI) scores, a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety. | baseline, after the 2-weeks intervention, and 6 months after the intervention |
| Change of impulsiveness | The decrease of Barratt impulsiveness scale (BIS) scores，including 30 items. | baseline, after the 2-weeks intervention, and 6 months after the intervention |
| Change of impulse control | The decrease of stop signal reaction time （SSRT） in the stop signal task. | baseline, after the 2-weeks intervention, and 6 months after the intervention |
| Change of cognitive function | The increase of Cogstate scores. | baseline, after the 2-weeks intervention, and 6 months after the intervention |