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

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.

Study Overview

• Status: Unknown
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Device: Intermittent Theta Burst Stimulation (iTBS); Device: Sham stimulation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Recruiting
      • Shanghai Mental Health Center
      • Contact: Chenxin Yuan; Phone Number: 18616819260; Email: yuan_ycx@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Real stimulation	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 Comparator: Control Group; Sham stimulation	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Change of cognitive function	The increase of Cogstate scores.	baseline, after the 2-weeks intervention, and 6 months after the intervention

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2019
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: April 17, 2019
• First Submitted That Met QC Criteria: April 26, 2019
• First Posted (Actual): April 30, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Alcohol Dependence; Alcohol Use Disorder; Intermittent Theta Burst Stimulation
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Alcoholism; Disease
• Other Study ID Numbers: JDu-007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No