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

Primary Purpose

Alcohol Use Disorder

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intermittent Theta Burst Stimulation (iTBS)
Sham stimulation
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder focused on measuring Alcohol Use Disorder, Intermittent Theta Burst Stimulation, Alcohol Dependence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Shanghai Mental Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Experimental Group

Control Group

Arm Description

Real stimulation

Sham stimulation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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 .
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.
Change of impulsiveness
The decrease of Barratt impulsiveness scale (BIS) scores,including 30 items.
Change of impulse control
The decrease of stop signal reaction time (SSRT) in the stop signal task.
Change of cognitive function
The increase of Cogstate scores.

Full Information

First Posted
April 17, 2019
Last Updated
March 23, 2020
Sponsor
Shanghai Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT03932149
Brief Title
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

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 6, 2019 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
Keywords
Alcohol Use Disorder, Intermittent Theta Burst Stimulation, Alcohol Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Real stimulation
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
Sham stimulation
Intervention Type
Device
Intervention Name(s)
Intermittent Theta Burst Stimulation (iTBS)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Craving change
Description
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.
Time Frame
baseline, after the intervention, and 3 months after the intervention
Secondary Outcome Measure Information:
Title
The abstinence rate after the treatment
Description
The abstinence rate defined as the number of abstinent days in the three months after the last simulation session
Time Frame
after the intervention, and 3 months after the intervention
Title
Change of depression
Description
The decrease of Beck Depression Inventory (BDI) scores, a 21-question multiple-choice self-report inventory to measure the severity of depression .
Time Frame
bbaseline, after the 2-weeks intervention, and 6 months after the intervention
Title
Change of anxiety
Description
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.
Time Frame
baseline, after the 2-weeks intervention, and 6 months after the intervention
Title
Change of impulsiveness
Description
The decrease of Barratt impulsiveness scale (BIS) scores,including 30 items.
Time Frame
baseline, after the 2-weeks intervention, and 6 months after the intervention
Title
Change of impulse control
Description
The decrease of stop signal reaction time (SSRT) in the stop signal task.
Time Frame
baseline, after the 2-weeks intervention, and 6 months after the intervention
Title
Change of cognitive function
Description
The increase of Cogstate scores.
Time Frame
baseline, after the 2-weeks intervention, and 6 months after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chenxin Yuan
Phone
18616819260
Email
yuan_ycx@163.com
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chenxin Yuan
Phone
18616819260
Email
yuan_ycx@163.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
32218749
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.
Results Reference
derived

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

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