NCT05854693

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress98%
Apr 2023Jun 2026

Study Start

First participant enrolled

April 17, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 18, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 11, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

May 11, 2023

Status Verified

May 1, 2022

Enrollment Period

3.1 years

First QC Date

April 18, 2023

Last Update Submit

May 2, 2023

Conditions

Alcohol Dependence

Keywords

Transcranial Direct Current Stimulation, craving

Outcome Measures

Primary Outcomes (1)

  • Change in alcohol craving

    Measured by visual analog scale, from 0-10

    Before intervention (week 0) and after intervention (week 2)

Secondary Outcomes (1)

  • Change in brain-derived neurotrophic factor (BDNF)

    Before intervention (week 0) and after intervention (week 2)

Study Arms (2)

Active tDCS

EXPERIMENTAL

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

Sham tDCS

SHAM COMPARATOR

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

Device: sham stimulation

Interventions

transCranial direct current stimulationDEVICE

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

Active tDCS
sham stimulationDEVICE

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

Sham tDCS

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei City Hospital

Taipei, Taipei CITY, 105, Taiwan

RECRUITING

MeSH Terms

Conditions

Alcoholism

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Central Study Contacts

Hu-Ming Chang

CONTACT

0978052951DAU66@tpech.gov.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2023

First Posted

May 11, 2023

Study Start

April 17, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

May 11, 2023

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)