NCT05738174

Brief Summary

This is a two-arm randomized placebo-controlled trial in which 72 patients with alcohol addiction are treated with high-dose accelerated intermittent theta burst stimulation (TBS).

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

2.8 years

First QC Date

February 7, 2023

Last Update Submit

September 18, 2025

Conditions

Alcohol Dependence

Outcome Measures

Primary Outcomes (1)

  • Craving visual analoge scale

    alcohol craving according to visual analog scale (range: 0-100; higher values = worse outcome)

    one week

Secondary Outcomes (8)

  • Craving visual analoge scale

    13 weeks

  • relapse (number of patients with alcohol relapse)

    13 weeks

  • heavy drinking days

    13 weeks

  • abstinence confidence

    13 weeks

  • degree of dependence

    13 weeks

  • +3 more secondary outcomes

Study Arms (2)

intermittent theta burst stimulation (iTBS)

EXPERIMENTAL

1200 pulses of iTBS per session with five sessions per day applied at five days (Monday-Friday) with 120% resting motor threshold

Device: high-dose accelerated intermittent theta burst stimulation

sham treatment

SHAM COMPARATOR

1200 pulses of iTBS per session with five sessions per day applied at five days (Monday-Friday) with 120% resting motor threshold with angled coil

Device: sham high-dose accelerated intermittent theta burst stimulation

Interventions

high-dose accelerated intermittent theta burst stimulationDEVICE

1200 pulses of iTBS per session with five sessions per day applied at five days (Monday-Friday) with 120% resting motor threshold

intermittent theta burst stimulation (iTBS)
sham high-dose accelerated intermittent theta burst stimulationDEVICE

1200 pulses of iTBS per session with five sessions per day applied at five days (Monday-Friday) with 120% resting motor threshold with angled coil

sham treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • alchohol dependence according to ICD-10 (F10.2)
  • desire to reduce or abstain from alcohol drinking
  • male or female
  • years
  • residency in Germany, German speaking
  • written informed consent

You may not qualify if:

  • contraindications for transcranial magnetic stimulation (electric devices or metal parts in the body such as pacemaker)
  • relevant neurological or internistic diseases according to study investigator
  • treatment with TMS in the past
  • participation in other trials during treatment
  • pregnancy or breatfeeding
  • positive breath test for alcohol
  • legal care and placement in a psychiatric hospital
  • co-medication with disulfiram, acamprosate, topiramate, baclofen, naltrexone, or nalmefene
  • acute psychiatric comorbidity that requires inpatient treatment or medication readjustment (\<1 month)
  • severe chronic psychiatric illness (schizophrenia, schizoaffective disorder, bipolar disorder)
  • patients who are unable to complete study questionnaires or follow-up questionnaires (in the opinion of the investigators)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry and Psychotherapy, University of Regensburg

Regensburg, 93055, Germany

RECRUITING

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Berthold Langguth

    University Hospital of Regensburg, Department of Psychiatry and Psychotherapy at the Bezirksklinikum

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Schecklmann, Prof.

CONTACT

+49-941-941-1256martin.schecklmann@medbo.com

Johannes Huebner

CONTACT

+49-941-941-0johannes.huebner@medbo.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

February 7, 2023

First Posted

February 21, 2023

Study Start

March 1, 2023

Primary Completion

December 30, 2025

Study Completion

February 28, 2026

Last Updated

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)