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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-06

Study Completion Date

2021-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Intermittent Theta Burst for the Treatment of Alcohol Use Disorders in Veterans

NCT03291431

Alcohol Use Disorder Depressive Disorder Cigarette Smoking

TERMINATED NA

Effect of Intermittent Theta Burst Stimulation (iTBS) for Alleviating Symptoms of Schizophrenia Patients

NCT03868358

Schizophrenia Functional Magnetic Resonance Imaging Transcranial Magnetic Stimulation

COMPLETED NA

aTBS for Treatment of Depression in AUD

NCT03981185

Alcohol Use Disorder Depression

WITHDRAWN NA

Effect of Intermittent ThetaBurst Stimulation in Treatment-resistant Bipolar Depression

NCT02740244

Bipolar Depression

TERMINATED NA

The Antidepressant Effect of Intermittent Theta Burst Stimulation (iTBS)

NCT05516095

Depression Executive Dysfunction

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alcohol Use Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental Group

Real stimulation

Group Type EXPERIMENTAL

Intermittent Theta Burst Stimulation (iTBS)

Intervention Type 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.

Control Group

Sham stimulation

Group Type SHAM_COMPARATOR

Sham stimulation

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No