NCT07755046

Brief Summary

This study looked at whether repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation treatment, could help adults with alcohol use disorder when added to their usual treatment. Nine adults receiving abstinence-oriented care received 10 sessions of stimulation over the right front part of the brain. Drinking severity, mood, craving and quality of life were assessed before treatment, immediately after the 10 sessions, and again at one and three months. Brain scans were also obtained at these visits to examine whether stimulation was associated with changes in brain connections. The study had no comparison group, so the results cannot show whether any change was caused by the stimulation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

June 10, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 10, 2026

Completed
Last Updated

August 10, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 5, 2026

Last Update Submit

August 5, 2026

Conditions

Keywords

Repetitive transcranial magnetic stimulationDorsolateral prefrontal cortexAlcohol Use Disorders Identification TestResting-state functional MRIDiffusion tensor imagingMagnetic resonance spectroscopyPilot study

Outcome Measures

Primary Outcomes (1)

  • Change in Alcohol Use Disorders Identification Test (AUDIT) total score

    AUDIT total score, range 0 to 40, with higher scores indicating more severe alcohol-related problems. Change from baseline was assessed at each follow-up.

    Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months

Secondary Outcomes (7)

  • Change in Patient Health Questionnaire-9 (PHQ-9) score

    Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months

  • Change in craving visual analogue scale score

    Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months

  • Change in WHOQOL-BREF total score

    Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months

  • Change in resting-state functional connectivity

    Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months

  • Change in white matter diffusion metrics

    Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months

  • +2 more secondary outcomes

Study Arms (1)

Active rTMS

EXPERIMENTAL

Ten sessions of active repetitive transcranial magnetic stimulation over the right dorsolateral prefrontal cortex (F4), at 10 Hz and 110% of the visually determined resting motor threshold, 60 trains of five seconds each, 3,000 pulses per session over approximately 30 minutes, delivered on consecutive weekdays. All participants received active stimulation in addition to usual abstinence-oriented care, which included pharmacological and psychosocial treatment that was not protocolized.

Device: Repetitive transcranial magnetic stimulation

Interventions

High-frequency repetitive transcranial magnetic stimulation

Active rTMS

Eligibility Criteria

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

You may qualify if:

  • Adults aged 20 to 65 years
  • Diagnosis of alcohol use disorder according to DSM-5 criteria
  • Able to provide written informed consent and complete study procedures

You may not qualify if:

  • Moderate to severe alcohol withdrawal
  • Psychiatric symptoms interfering with alcohol use disorder treatment
  • Acute physical illness requiring hospitalization
  • Standard contraindications to repetitive transcranial magnetic stimulation
  • Pregnancy or planned pregnancy within one year
  • Formal disability certification related to a psychiatric disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Veterans General Hospital, Taiwan

Taichung, Taiwan, 407219, Taiwan

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Originally designed as a two-arm, randomized, double-blind, sham-controlled trial. Funding constraints and recruitment difficulty prevented completion of that design; all enrolled participants received active stimulation and the study was conducted as a single-arm, open-label pilot.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief, Division of Addiction Medicine, Department of Psychiatry, Taichung Veterans General Hospital, Taiwan

Study Record Dates

First Submitted

August 5, 2026

First Posted

August 10, 2026

Study Start

June 10, 2025

Primary Completion

June 14, 2026

Study Completion

June 14, 2026

Last Updated

August 10, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual-level data are not publicly available given the small sample and the potentially identifiable nature of the clinical data; de-identified data and analysis code may be made available by the corresponding author on reasonable request, subject to institutional review board approval.

Locations