The Effect of Intermittent Theta Burst Stimulation (iTBS) in Patients With Alcohol Use Disorder

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Intermittent Theta Burst Stimulation (iTBS) in Patients With Alcohol Use Disorder

Conditions
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Alcohol Use Disorder

Intervention / Treatment
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* Device: Intermittent Theta Burst Stimulation (iTBS)
* Device: Sham stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a DSM-5 diagnosis of alcohol use disorder age between 18 and 65 can return to the research center for successive visits. Exclusion Criteria: severe cognitive impairment current DSM-5 diagnosis of schizophrenia or another psychotic disorder current other substance abuse (except nicotine) severe organic diseases rTMS contraindications (such as a history of epileptic seizures, metal implants near the head).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Real stimulation | Device: Intermittent Theta Burst Stimulation (iTBS)<br>* 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.<br>|
| Sham Comparator: Control Group<br>Sham stimulation | Device: Sham stimulation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol Use Disorder, Intermittent Theta Burst Stimulation, Alcohol Dependence