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

Alcohol Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03932149
• Other study ID #: JDu-007
• Status: Recruiting
• Phase: N/A
• Start date: December 6, 2019
• Est. completion date: March 2021

Study information

• Verified date: April 2019
• Source: Shanghai Mental Health Center
• Contact: Chenxin Yuan
• Phone: 18616819260
• Email: yuan_ycx[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Disease

Intervention

Device:
• Intermittent 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.
• Sham 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.

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Craving 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.	baseline, after the intervention, and 3 months after the intervention
Secondary	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	after the intervention, and 3 months after the intervention
Secondary	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 .	bbaseline, after the 2-weeks intervention, and 6 months after the intervention
Secondary	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.	baseline, after the 2-weeks intervention, and 6 months after the intervention
Secondary	Change of impulsiveness	The decrease of Barratt impulsiveness scale (BIS) scores,including 30 items.	baseline, after the 2-weeks intervention, and 6 months after the intervention
Secondary	Change of impulse control	The decrease of stop signal reaction time (SSRT) in the stop signal task.	baseline, after the 2-weeks intervention, and 6 months after the intervention
Secondary	Change of cognitive function	The increase of Cogstate scores.	baseline, after the 2-weeks intervention, and 6 months after the intervention