Alcohol Use Disorder
Conditions
Keywords
Alcohol Use Disorder, Intermittent Theta Burst Stimulation, Alcohol Dependence
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.
Interventions
DEVICEIntermittent Theta Burst Stimulation (iTBS)
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.
DEVICESham stimulation
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.
Sponsors
Shanghai Mental Health Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
| 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. |
Countries
China
Contacts
Primary ContactChenxin Yuan
Outcome results
None listed