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

Shanghai Mental Health Center

Status: Unknown

Conditions: Alcohol Use Disorder

Treatments: Device: Intermittent Theta Burst Stimulation (iTBS); Device: Sham stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03932149

JDu-007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Experimental Group

Experimental group

Description:

Real stimulation

Treatment:

Device: Intermittent Theta Burst Stimulation (iTBS)

Control Group

Sham Comparator group

Description:

Sham stimulation

Treatment:

Device: Sham stimulation