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NCT Number: NCT05738174

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

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).

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Key information

Conditions

Alcohol Dependence Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry and Psychotherapy, University of Regensburg

Regensburg, 93055, Germany

Location status: Recruiting

Location contact

Berthold Langguth

CONTACT

[email protected]

+49-941-941-2099

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

high-dose accelerated intermittent theta burst stimulation

Device

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

sham high-dose accelerated intermittent theta burst stimulation

Device

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

Primary outcomes

  1. Craving visual analoge scale

    Time frame: one week

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

Secondary outcomes

  1. Craving visual analoge scale

    Time frame: 13 weeks

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

  2. relapse (number of patients with alcohol relapse)

    Time frame: 13 weeks

    number of patients with alcohol relapse

  3. heavy drinking days

    Time frame: 13 weeks

    number of heavy drinking days (four drinks for female and five drinks for male)

  4. abstinence confidence

    Time frame: 13 weeks

    abstinence confidence (Kurzfragebogen zur Abstinenzzuversicht KAZ-35; only available in German; range: 0-100%; higher values = worse outcome)

  5. degree of dependence

    Time frame: 13 weeks

    degree of dependence according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) (range: mild, moderate, severe)

  6. Fagerström Test for Nicotine Dependence

    Time frame: 13 weeks

    Fagerström Test for Nicotine Dependence (range: 0-10; higher values = worse outcome)

  7. major depression inventory

    Time frame: 13 weeks

    Major Depression Inventory (range: 0-50; higher values = worse outcome)

  8. World Health Organisation quality of life bref

    Time frame: 13 weeks

    World Health Organisation quality of life bref (range: 4-20; lower values = worse outcome)

Study contacts

Contact information is provided by the study sponsor or research team.

Johannes Huebner

CONTACT

[email protected]

+49-941-941-0

Martin Schecklmann, Prof.

CONTACT

[email protected]

+49-941-941-1256

Sponsors and collaborators

Lead sponsor

Berthold Langguth, MD, Ph.D.

Other

Registry information

Official study title

Theta Burst Zur Behandlung Der Alkoholabhängigkeit

Acronym: TBA

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Feb 21, 2023
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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