search
Back to results

Trans-cranial Direct Current Stimulation on Alcohol Craving

Primary Purpose

Alcohol Dependence

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
transCranial direct current stimulation
sham stimulation
Sponsored by
Taipei City Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring Transcranial Direct Current Stimulation, craving

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Be between 20-65 years of age have sufficient cognitive function to understand the study and complete the informed consent process Be diagnosed with alcohol dependence as defined by DSM-IV through a structured interview (Mini-International Neuropsychiatric Interview, M.I.N.I.) Exclusion Criteria: Intellectual disabilities bipolar disorder Psychosis (schizophrenia) Major physical illness (brain hemorrhage, brain tumor, myocardial infarction, epilepsy or history of seizures) intracorporeal electronic or metal implants (e.g., cardiac pacemaker) Pregnant or breastfeeding women Allergy to headgear and electrode materials Trauma or infection to the head Intracranial space occupied lesion (such as brain tumor, AVM, etc.) or patients who have undergone brain surgery, meningitis and encephalitis Patients who are expected to undergo brain and major surgery during the trial period

Sites / Locations

  • Taipei City HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active tDCS

Sham tDCS

Arm Description

The intervention consisted of 10 daily 20-min sessions of bilateral prefrontal tDCS (anodal-right/cathodal-left, 2mA; 1 × 1 Mini-CT)

The sham group consisted of 10 daily 20-min sessions of sham stimulation

Outcomes

Primary Outcome Measures

Change in alcohol craving
Measured by visual analog scale, from 0-10

Secondary Outcome Measures

Change in brain-derived neurotrophic factor (BDNF)
Serum level of BDNF

Full Information

First Posted
April 18, 2023
Last Updated
May 2, 2023
Sponsor
Taipei City Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05854693
Brief Title
Trans-cranial Direct Current Stimulation on Alcohol Craving
Official Title
Exploring the Effect of Trans-cranial Direct Current Stimulation on Craving and Serum BDNF of Patients With Alcohol Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2023 (Actual)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei City Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of thisclinical trial is to investigate the efficacy of trans cranial direct current stimulation (tDCS) for alcohol craving in individuals with alcohol dependence. The main question it aims to answer is whether 10 sessions of tDCS can reduce craving for alcohol. Participants will be randomized into active group and sham group. Researchers will compare the severity of craving in these groups.
Detailed Description
Craving is defined as strong desire for substance use, and is one of the core symptoms of alcohol dependence which is highly correlated with relapse. Transcranial direct current stimulation (tDCS) involves applying a small direct current (1-2mA) to the prefrontal cortex; its therapeutic effect for depression and cognition has been demonstrated by several randomized studies. Our preliminary study has shown that tDCS has the potential to reduce craving in alcohol-dependent patients without adverse events. Furthermore, our previous studies have shown that serum brain-derived neurotrophic factor (BDNF) level is elevated after alcohol withdrawal. The current study aims at examining the association between craving and serum BDNF level in alcohol-dependent patients receiving tDCS. The study recruits 40 patients with alcohol dependence. Patients will receive tDCS for 2 weeks during admission, and followed for 2 weeks after tDCS. We'll compare their improvements in craving scores every week, and investigate the correlation between craving and serum BDNF level. This study will bring innovations to the treatment of alcohol dependence based on our previous studies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
Keywords
Transcranial Direct Current Stimulation, craving

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Active tDCS
Arm Type
Experimental
Arm Description
The intervention consisted of 10 daily 20-min sessions of bilateral prefrontal tDCS (anodal-right/cathodal-left, 2mA; 1 × 1 Mini-CT)
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
The sham group consisted of 10 daily 20-min sessions of sham stimulation
Intervention Type
Device
Intervention Name(s)
transCranial direct current stimulation
Intervention Description
The intervention consisted of 20 daily 20-min sessions of bilateral prefrontal tDCS
Intervention Type
Device
Intervention Name(s)
sham stimulation
Intervention Description
The sham group consisted of 10 daily 20-min sessions of sham stimulation
Primary Outcome Measure Information:
Title
Change in alcohol craving
Description
Measured by visual analog scale, from 0-10
Time Frame
Before intervention (week 0) and after intervention (week 2)
Secondary Outcome Measure Information:
Title
Change in brain-derived neurotrophic factor (BDNF)
Description
Serum level of BDNF
Time Frame
Before intervention (week 0) and after intervention (week 2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be between 20-65 years of age have sufficient cognitive function to understand the study and complete the informed consent process Be diagnosed with alcohol dependence as defined by DSM-IV through a structured interview (Mini-International Neuropsychiatric Interview, M.I.N.I.) Exclusion Criteria: Intellectual disabilities bipolar disorder Psychosis (schizophrenia) Major physical illness (brain hemorrhage, brain tumor, myocardial infarction, epilepsy or history of seizures) intracorporeal electronic or metal implants (e.g., cardiac pacemaker) Pregnant or breastfeeding women Allergy to headgear and electrode materials Trauma or infection to the head Intracranial space occupied lesion (such as brain tumor, AVM, etc.) or patients who have undergone brain surgery, meningitis and encephalitis Patients who are expected to undergo brain and major surgery during the trial period
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hu-Ming Chang
Phone
0978052951
Email
DAU66@tpech.gov.tw
Facility Information:
Facility Name
Taipei City Hospital
City
Taipei
State/Province
Taipei CITY
ZIP/Postal Code
105
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hu-Ming Chang
Phone
0978052951
Email
DAU66@tpech.gov.tw

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Trans-cranial Direct Current Stimulation on Alcohol Craving

We'll reach out to this number within 24 hrs