Alcohol DependenceTBANCT05738174
High-dose Accelerated Theta Burst Stimulation for the Treatment of Alcohol Addiction
A study testing high-dose accelerated intermittent theta burst stimulation in people with Alcohol Dependence, run by Berthold Langguth, MD, Ph.D. at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- high-dose accelerated intermittent theta burst stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2023to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Psychiatry and Psychotherapy, University of Regensburg
Regensburg, 93055
Berthold Langguth, +49-941-941-2099, berthold.langguth@medbo.de
About this study
Official title: 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).
- Conditions
- Alcohol Dependence
- Being tested
- high-dose accelerated intermittent theta burst stimulation, sham high-dose accelerated intermittent theta burst stimulation
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: sham high-dose accelerated intermittent theta burst stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Craving visual analoge scale
alcohol craving according to visual analog scale (range: 0-100; higher values = worse outcome)
Measured: one week
Secondary outcomes (8)
Craving visual analoge scale
alcohol craving according to visual analog scale (range: 0-100; higher values = worse outcome)
Measured: 13 weeks
relapse (number of patients with alcohol relapse)
number of patients with alcohol relapse
Measured: 13 weeks
heavy drinking days
number of heavy drinking days (four drinks for female and five drinks for male)
Measured: 13 weeks
abstinence confidence
abstinence confidence (Kurzfragebogen zur Abstinenzzuversicht KAZ-35; only available in German; range: 0-100%; higher values = worse outcome)
Measured: 13 weeks
degree of dependence
degree of dependence according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) (range: mild, moderate, severe)
Measured: 13 weeks
Fagerström Test for Nicotine Dependence
Fagerström Test for Nicotine Dependence (range: 0-10; higher values = worse outcome)
Measured: 13 weeks
major depression inventory
Major Depression Inventory (range: 0-50; higher values = worse outcome)
Measured: 13 weeks
World Health Organisation quality of life bref
World Health Organisation quality of life bref (range: 4-20; lower values = worse outcome)
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Mar 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Berthold Langguth, MD, Ph.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Berthold Langguth, MD, Ph.D., University of Regensburg
- Investigators
- Berthold Langguth, Principal investigator, University Hospital of Regensburg, Department of Psychiatry and Psychotherapy at the Bezirksklinikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05738174
- Sponsor's protocol ID
- 23-3261-101
- Acronym
- TBA
- Status last verified
- Sep 2025
- First submitted
- 7 Feb 2023
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Theta Burst Zur Behandlung Der Alkoholabhängigkeit
- ClinicalTrials.gov ID
- NCT05738174
- Acronym / sponsor ID
- TBA / 23-3261-101
- Conditions
- Alcohol Dependence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Berthold Langguth, MD, Ph.D.University, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intermittent theta burst stimulation (iTBS) | Experimental | Device: high-dose accelerated intermittent theta burst stimulation1200 pulses of iTBS per session with five sessions per day applied at five days (Monday-Friday) with 120% resting motor threshold |
| sham treatment | Sham comparator | Device: sham high-dose accelerated intermittent theta burst stimulation1200 pulses of iTBS per session with five sessions per day applied at five days (Monday-Friday) with 120% resting motor threshold with angled coil |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high-dose accelerated intermittent theta burst stimulation1200 pulses of iTBS per session with five sessions per day applied at five days (Monday-Friday) with 120% resting motor threshold | Device | intermittent theta burst stimulation (iTBS) |
| sham high-dose accelerated intermittent theta burst stimulation1200 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 treatment |
Primary outcome
Craving visual analoge scale
Time frame: one week
alcohol craving according to visual analog scale (range: 0-100; higher values = worse outcome)
8 secondary outcomes
Craving visual analoge scale
Time frame: 13 weeks
relapse (number of patients with alcohol relapse)
Time frame: 13 weeks
heavy drinking days
Time frame: 13 weeks
abstinence confidence
Time frame: 13 weeks
degree of dependence
Time frame: 13 weeks
Fagerström Test for Nicotine Dependence
Time frame: 13 weeks
major depression inventory
Time frame: 13 weeks
World Health Organisation quality of life bref
Time frame: 13 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Alcohol Dependence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
RecruitingPhase 2
Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
Alcohol Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Berthold Langguth principal investigator
University Hospital of Regensburg, Department of Psychiatry and Psychotherapy at the Bezirksklinikum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high-dose accelerated intermittent theta burst stimulation in people with Alcohol Dependence, run by Berthold Langguth, MD, Ph.D. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Schecklmann, Prof. (+49-941-941-1256, martin.schecklmann@medbo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Craving visual analoge scale (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.