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

March 23, 2020 updated by: Shanghai Mental Health Center
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Shanghai Mental Health Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: baseline, after the intervention, and 3 months after the intervention
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
Time Frame: after the intervention, and 3 months after the intervention
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
Time Frame: bbaseline, after the 2-weeks intervention, and 6 months after the intervention
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
Time Frame: baseline, after the 2-weeks intervention, and 6 months after the intervention
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
Time Frame: baseline, after the 2-weeks intervention, and 6 months after the intervention
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
Time Frame: baseline, after the 2-weeks intervention, and 6 months after the intervention
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
Time Frame: baseline, after the 2-weeks intervention, and 6 months after the intervention
The increase of Cogstate scores.
baseline, after the 2-weeks intervention, and 6 months after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Mental Health Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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