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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
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.
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.
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
RECRUITINGCraving 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.
Time frame: baseline, after the intervention, and 3 months after the intervention
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
Time frame: 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 .
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline, after the 2-weeks intervention, and 6 months after the intervention
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Change of cognitive function
The increase of Cogstate scores.
Time frame: baseline, after the 2-weeks intervention, and 6 months after the intervention