The Effect of Intermittent Theta Burst Stimulation (iTBS) in Patients With Alcohol Use Disorder
- Conditions
- Alcohol Use Disorder
- Interventions
- Device: Intermittent Theta Burst Stimulation (iTBS)Device: Sham stimulation
- Registration Number
- NCT03932149
- Lead Sponsor
- Shanghai Mental Health Center
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- a DSM-5 diagnosis of alcohol use disorder
- age between 18 and 65
- can return to the research center for successive visits.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Group Intermittent Theta Burst Stimulation (iTBS) Real stimulation Control Group Sham stimulation Sham stimulation
- Primary Outcome Measures
Name Time Method Craving change baseline, after the intervention, and 3 months after the intervention 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.
- Secondary Outcome Measures
Name Time Method Change of cognitive function baseline, after the 2-weeks intervention, and 6 months after the intervention The increase of Cogstate scores.
Change of impulsiveness baseline, after the 2-weeks intervention, and 6 months after the intervention The decrease of Barratt impulsiveness scale (BIS) scores，including 30 items.
The abstinence rate after the treatment after the intervention, and 3 months after the intervention The abstinence rate defined as the number of abstinent days in the three months after the last simulation session
Change of depression bbaseline, after the 2-weeks intervention, and 6 months after the intervention The decrease of Beck Depression Inventory (BDI) scores, a 21-question multiple-choice self-report inventory to measure the severity of depression .
Change of anxiety baseline, after the 2-weeks intervention, and 6 months after the intervention 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.
Change of impulse control baseline, after the 2-weeks intervention, and 6 months after the intervention The decrease of stop signal reaction time （SSRT） in the stop signal task.
Trial Locations
- Locations (1)
Shanghai Mental Health Center
🇨🇳Shanghai, Shanghai, China