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A Study of the Effectiveness of Direct Current Stimulation for Alcohol Use Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04135599
Recruitment Status : Not yet recruiting
First Posted : October 22, 2019
Last Update Posted : October 22, 2019
Sponsor:
Collaborator:
Wuhan Union Hospital, China
Information provided by (Responsible Party):
Shanghai Mental Health Center

Brief Summary:

Transcranial direct current stimulation (tDCS) is a non-invasive, safe and easy-to-operate neuro-electrophysiological technique, which becoming an emerging therapeutic option for many mental disorders.It can modulate cortical excitability of target brain region, neuron plasticity and brain connections. Previous studies suggest that tDCS could reduce cue-induced craving in drug addiction.

Objective:In this study, the investigators employed real and sham tDCS of the bilateral dorsolateral prefrontal cortex (DLPFC) to test the effect of whether it could reduce cue-induced craving, influence cognitive function in alcoholics and explore its underlying mechanism with functional magnetic resonance imaging (fMRI).

Methods: The investigators perform a randomized sham-controlled study in which 40 inpatient alcoholics will be randomized to receive 10 sessions of 20min sham or 1.5mA tDCS to the bilateral DLPFC (anodal right/cathodal left). The neuroimaging data, craving after exposed to alcohol-associated cues and the cognition task at baseline and after stimulation will be collected.

The investigators hypothesized that tDCS stimulating the DLPFC decreases cue-induced craving and improves cognition, which might be associated with the functional connectivity alterations.


Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Device: transcranial direct current stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation of the Bilateral Dorsolateral Prefrontal Cortex for Alcohol Use Disorders: A Randomised, Sham-controlled Clinical Trial
Estimated Study Start Date : October 31, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Active Comparator: real tDCS
Participants received 1.5mA tDCS for 20 minutes in 10 consecutive days.
Device: transcranial direct current stimulation
Transcranial direct current stimulation (tDCS) is a non-invasive, safe and easy-to-operate neuro-electrophysiological technique, which becoming an emerging therapeutic option for many mental disorders.It can modulate cortical excitability of target brain region, neuron plasticity and brain connections. Previous studies suggest that tDCS could reduce cue-induced craving and improve cognition in drug addiction.

Sham Comparator: sham tDCS
Participants received sham tDCS for 20 minutes in 10 consecutive days.
Device: transcranial direct current stimulation
Transcranial direct current stimulation (tDCS) is a non-invasive, safe and easy-to-operate neuro-electrophysiological technique, which becoming an emerging therapeutic option for many mental disorders.It can modulate cortical excitability of target brain region, neuron plasticity and brain connections. Previous studies suggest that tDCS could reduce cue-induced craving and improve cognition in drug addiction.




Primary Outcome Measures :
  1. Change from baseline functional magnetic resonance imaging at 2 weeks [ Time Frame: Two weeks ]
    Stop signal task during fMRI scanning (Philips Ingenia 3.0T MRI).


Secondary Outcome Measures :
  1. cue-induced craving [ Time Frame: Two weeks ]
    Participants were instructed to pay close attention to real alcoholic beverages and rate their level of craving after smelling and recalling the last time they engaged in alcohol use. Craving was assessed by visual analog scales (VAS), with 0 mm being "no craving"and 100 mm representing "most craving ever experienced for alcohol".

  2. Cognitive function [ Time Frame: Two weeks ]
    Chinese version of the CogState Battery was used to assess cognitive function. We selected two tasks: Two back task (working memory) and Identification task (attention) which were displayed on a green screen with standardized instructions before each task beginning.The accuracy in Two back task and the speed in Identification task are our focus.

  3. Relapse [ Time Frame: One month after discharge from the hospital ]
    Meet the criteria for mild to severe AUD defined in the Diagnostic and Statistical Manual of Mental Disorders-Fifth edition (DSM-5)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:(1)Clinical diagnosis of severe AUD defined in the Diagnostic and Statistical Manual of Mental Disorders-Fifth edition (DSM-5); (2)Must be able to look and hear; (3) Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar) score less than 10.

Exclusion Criteria:(1) Clinical diagnosis of substance use disorder other than an alcohol or nicotine use disorder defined in the Diagnostic and Statistical Manual of Mental Disorders-Fifth edition (DSM-5);(2) Severe brain injury, stroke, seizure, epilepsy or other major neurological diseases ; (3) Schizophrenia, bipolar disorder, depression or other Axis I disorder of DSM-V criteria;(4)any contraindication for fMRI scanning.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04135599


Contacts
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Contact: Na Zhong, Doctor 008613671644472 winco917@hotmail.com

Sponsors and Collaborators
Shanghai Mental Health Center
Wuhan Union Hospital, China
Investigators
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Principal Investigator: Na Zhong, Doctor Shanghai Mental Health Center
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Responsible Party: Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT04135599    
Other Study ID Numbers: NZhong-004
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alcoholism
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders