CClinicalTrials.gg
RecruitingNCT05738174TBAUpdated Sep 19, 2025

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

An interventional study of high-dose accelerated intermittent theta burst stimulation and sham high-dose accelerated intermittent theta burst stimulation in Alcohol Dependence, sponsored by Berthold Langguth, MD, Ph.D.. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-09-19.

Sponsored by Berthold Langguth, MD, Ph.D. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Mar 2023; still recruiting 3 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Alcohol Dependence

Browse trials for

03

In context

Alcoholism

1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.

This study's planned enrollment of 72 is below the median of 87 across 1,371 interventional studies indexed under Alcoholism.

Browse Alcoholism studies →

Lead sponsor

Berthold Langguth, MD, Ph.D. is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
72 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Devicehigh-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

  • Devicesham 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

06

What researchers measure

Primary outcomes

  1. Craving visual analoge scale

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

    Time frame: one week

Secondary outcomes

  1. Craving visual analoge scale

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

    Time frame: 13 weeks

  2. relapse (number of patients with alcohol relapse)

    number of patients with alcohol relapse

    Time frame: 13 weeks

  3. heavy drinking days

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

    Time frame: 13 weeks

  4. abstinence confidence

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

    Time frame: 13 weeks

  5. degree of dependence

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

    Time frame: 13 weeks

  6. Fagerström Test for Nicotine Dependence

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

    Time frame: 13 weeks

  7. major depression inventory

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

    Time frame: 13 weeks

  8. World Health Organisation quality of life bref

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

    Time frame: 13 weeks

07

Study locations

1 of 1 sites recruiting
  • Department of Psychiatry and Psychotherapy, University of Regensburg
    Regensburg, 93055, Germany
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05738174
Lead sponsor
Berthold Langguth, MD, Ph.D.
Responsible party
Berthold Langguth, MD, Ph.D. (Prof. Dr., University of Regensburg) — Sponsor-investigator
First posted
Feb 21, 2023
Start date
Mar 1, 2023
Primary completion
Dec 30, 2025 (estimated)
Completion
Feb 28, 2026 (estimated)
Last update
Sep 19, 2025

Study contacts

Martin Schecklmann, Prof.
Contact
martin.schecklmann@medbo.com
+49-941-941-1256
Johannes Huebner
Contact
johannes.huebner@medbo.de
+49-941-941-0
Berthold Langguth
principal investigator · University Hospital of Regensburg, Department of Psychiatry and Psychotherapy at the Bezirksklinikum

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion