High-dose Accelerated Theta Burst Stimulation for the Treatment of Alcohol Addiction (TBA)

Theta Burst Zur Behandlung Der Alkoholabhängigkeit

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).

Study Overview

• Status: Recruiting
• Conditions: Alcohol Dependence
• Intervention / Treatment: Device: high-dose accelerated intermittent theta burst stimulation; Device: sham high-dose accelerated intermittent theta burst stimulation

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martin Schecklmann, Prof.; Phone Number: +49-941-941-1256; Email: martin.schecklmann@medbo.com
• Study Contact Backup: Name: Johannes Huebner; Phone Number: +49-941-941-0; Email: johannes.huebner@medbo.de

Study Locations

• Germany
  • Regensburg, Germany, 93055
    • Recruiting
    • Department of Psychiatry and Psychotherapy, University of Regensburg
    • Contact: Berthold Langguth; Phone Number: +49-941-941-2099; Email: berthold.langguth@medbo.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• alchohol dependence according to ICD-10 (F10.2)
• desire to reduce or abstain from alcohol drinking
• male or female
• 18-65 years
• residency in Germany, German speaking
• written informed consent

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intermittent theta burst stimulation (iTBS); 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; 1200 pulses of iTBS per session with five sessions per day applied at five days (Monday-Friday) with 120% resting motor threshold
Sham Comparator: sham treatment; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Craving visual analoge scale	alcohol craving according to visual analog scale (range: 0-100; higher values = worse outcome)	one week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Craving visual analoge scale	alcohol craving according to visual analog scale (range: 0-100; higher values = worse outcome)	13 weeks
relapse (number of patients with alcohol relapse)	number of patients with alcohol relapse	13 weeks
heavy drinking days	number of heavy drinking days (four drinks for female and five drinks for male)	13 weeks
abstinence confidence	abstinence confidence (Kurzfragebogen zur Abstinenzzuversicht KAZ-35; only available in German; range: 0-100%; higher values = worse outcome)	13 weeks
degree of dependence	degree of dependence according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) (range: mild, moderate, severe)	13 weeks
Fagerström Test for Nicotine Dependence	Fagerström Test for Nicotine Dependence (range: 0-10; higher values = worse outcome)	13 weeks
major depression inventory	Major Depression Inventory (range: 0-50; higher values = worse outcome)	13 weeks
World Health Organisation quality of life bref	World Health Organisation quality of life bref (range: 4-20; lower values = worse outcome)	13 weeks

Collaborators and Investigators

• Sponsor: Berthold Langguth, MD, Ph.D.
• Investigators: Principal Investigator: Berthold Langguth, University Hospital of Regensburg, Department of Psychiatry and Psychotherapy at the Bezirksklinikum

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: February 20, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 18, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Alcoholism
• Other Study ID Numbers: 23-3261-101

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