Clinical trial NCT03932149: The Effect of Intermittent Theta Burst Stimulation (iTBS) in Patients With Alcohol Use Disorder
Official title: The Effect of Intermittent Theta Burst Stimulation (iTBS) in Patients With Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: Alcohol Use Disorder
Intermittent Theta Burst Stimulation
Alcohol Dependence
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2019-04-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Craving change
timeFrame: baseline, after the intervention, and 3 months after the intervention
Secondary outcomes:
measure: The abstinence rate after the treatment
timeFrame: after the intervention, and 3 months after the intervention
measure: Change of depression
timeFrame: bbaseline, after the 2-weeks intervention, and 6 months after the intervention
measure: Change of anxiety
timeFrame: baseline, after the 2-weeks intervention, and 6 months after the intervention
measure: Change of impulsiveness
timeFrame: baseline, after the 2-weeks intervention, and 6 months after the intervention
measure: Change of impulse control
timeFrame: baseline, after the 2-weeks intervention, and 6 months after the intervention
measure: Change of cognitive function
timeFrame: baseline, after the 2-weeks intervention, and 6 months after the intervention
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
References:
citation: Yuan C, Su H, Chen T, Voon V, Du J. The Effect of Intermittent Theta Burst Stimulation (iTBS) in Patients With Alcohol Use Disorder: Study Protocol for a Randomized Controlled Trial. Front Psychiatry. 2020 Mar 10;11:210. doi: 10.3389/fpsyt.2020.00210. eCollection 2020.