Trans-cranial Direct Current Stimulation on Alcohol Craving

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

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.

Study Overview

• Status: Recruiting
• Conditions: Alcohol Dependence
• Intervention / Treatment: Device: transCranial direct current stimulation; Device: sham stimulation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hu-Ming Chang; Phone Number: 0978052951; Email: DAU66@tpech.gov.tw

Study Locations

• Taiwan
  • Taipei CITY
    • Taipei, Taipei CITY, Taiwan, 105
      • Recruiting
      • Taipei City Hospital
      • Contact: Hu-Ming Chang; Phone Number: 0978052951; Email: DAU66@tpech.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active tDCS; The intervention consisted of 10 daily 20-min sessions of bilateral prefrontal tDCS (anodal-right/cathodal-left, 2mA; 1 × 1 Mini-CT)	Device: transCranial direct current stimulation; The intervention consisted of 20 daily 20-min sessions of bilateral prefrontal tDCS
Sham Comparator: Sham tDCS; The sham group consisted of 10 daily 20-min sessions of sham stimulation	Device: sham stimulation; The sham group consisted of 10 daily 20-min sessions of sham stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in alcohol craving	Measured by visual analog scale, from 0-10	Before intervention (week 0) and after intervention (week 2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in brain-derived neurotrophic factor (BDNF)	Serum level of BDNF	Before intervention (week 0) and after intervention (week 2)

Collaborators and Investigators

• Sponsor: Taipei City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2023
• Primary Completion (Anticipated): June 1, 2026
• Study Completion (Anticipated): June 1, 2026

Study Registration Dates

• First Submitted: April 18, 2023
• First Submitted That Met QC Criteria: May 2, 2023
• First Posted (Estimate): May 11, 2023

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 2, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Transcranial Direct Current Stimulation, craving
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism
• Other Study ID Numbers: TCHIRB-10907010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No