Trans-cranial Direct Current Stimulation on Alcohol Craving

NCT ID: NCT05854693

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-17
• Study Completion Date: 2026-06-30

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.

Conditions

Alcohol Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active tDCS

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

Group Type: EXPERIMENTAL

transCranial direct current stimulation

Intervention Type: DEVICE

The intervention consisted of 20 daily 20-min sessions of bilateral prefrontal tDCS

Sham tDCS

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

Group Type: SHAM_COMPARATOR

sham stimulation

Intervention Type: DEVICE

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

Interventions

transCranial direct current stimulation

The intervention consisted of 20 daily 20-min sessions of bilateral prefrontal tDCS

Intervention Type: DEVICE

sham stimulation

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei City Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Taipei City Hospital

Taipei, Taipei CITY, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Hu-Ming Chang

Role: CONTACT

DAU66@tpech.gov.tw

0978052951

Facility Contacts

Hu-Ming Chang

Role: primary

DAU66@tpech.gov.tw

0978052951

Other Identifiers

TCHIRB-10907010

Identifier Type: -

Identifier Source: org_study_id