Trans-cranial Direct Current Stimulation on Alcohol Craving

Alcohol Dependence Clinical Trial

Official title:

Exploring the Effect of Trans-cranial Direct Current Stimulation on Craving and Serum BDNF of Patients With Alcohol Dependence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05854693
• Other study ID #: TCHIRB-10907010
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2023
• Est. completion date: June 2026

Study information

• Verified date: May 2022
• Source: Taipei City Hospital
• Contact: Hu-Ming Chang
• Phone: 0978052951
• Email: DAU66[@]tpech.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Be between 20-65 years of age

2. have sufficient cognitive function to understand the study and complete the informed consent process

3. Be diagnosed with alcohol dependence as defined by DSM-IV through a structured interview (Mini-International Neuropsychiatric Interview, M.I.N.I.)

Exclusion Criteria:

1. Intellectual disabilities

2. bipolar disorder

3. Psychosis (schizophrenia)

4. Major physical illness (brain hemorrhage, brain tumor, myocardial infarction, epilepsy or history of seizures)

5. intracorporeal electronic or metal implants (e.g., cardiac pacemaker)

6. Pregnant or breastfeeding women

7. Allergy to headgear and electrode materials

8. Trauma or infection to the head

9. Intracranial space occupied lesion (such as brain tumor, AVM, etc.) or patients who have undergone brain surgery, meningitis and encephalitis

10. Patients who are expected to undergo brain and major surgery during the trial period

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Device:
• transCranial direct current stimulation
The intervention consisted of 20 daily 20-min sessions of bilateral prefrontal tDCS
• sham stimulation
The sham group consisted of 10 daily 20-min sessions of sham stimulation

Locations

Country	Name	City	State
Taiwan	Taipei City Hospital	Taipei	Taipei CITY

Sponsors (1)

Lead Sponsor	Collaborator
Taipei City Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in alcohol craving	Measured by visual analog scale, from 0-10	Before intervention (week 0) and after intervention (week 2)
Secondary	Change in brain-derived neurotrophic factor (BDNF)	Serum level of BDNF	Before intervention (week 0) and after intervention (week 2)