NCT03932149

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 30, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

December 6, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

March 25, 2020

Status Verified

April 1, 2019

Enrollment Period

12 months

First QC Date

April 17, 2019

Last Update Submit

March 23, 2020

Conditions

Alcohol Use Disorder

Keywords

Alcohol Use DisorderIntermittent Theta Burst StimulationAlcohol Dependence

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • The abstinence rate after the treatment

    after the intervention, and 3 months after the intervention

  • Change of depression

    bbaseline, after the 2-weeks intervention, and 6 months after the intervention

  • Change of anxiety

    baseline, after the 2-weeks intervention, and 6 months after the intervention

  • Change of impulsiveness

    baseline, after the 2-weeks intervention, and 6 months after the intervention

  • Change of impulse control

    baseline, after the 2-weeks intervention, and 6 months after the intervention

  • +1 more secondary outcomes

Study Arms (2)

Experimental Group

EXPERIMENTAL

Real stimulation

Device: Intermittent Theta Burst Stimulation (iTBS)

Control Group

SHAM COMPARATOR

Sham stimulation

Device: Sham stimulation

Interventions

Intermittent Theta Burst Stimulation (iTBS)DEVICE

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.

Experimental Group
Sham stimulationDEVICE

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.

Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a DSM-5 diagnosis of alcohol use disorder
  • age between 18 and 65
  • can return to the research center for successive visits.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32218749DERIVED

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Central Study Contacts

Chenxin Yuan

CONTACT

18616819260yuan_ycx@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2019

First Posted

April 30, 2019

Study Start

December 6, 2019

Primary Completion

December 1, 2020

Study Completion

March 1, 2021

Last Updated

March 25, 2020

Record last verified: 2019-04

Locations

CN(1)