---
title: High-dose Accelerated Theta Burst Stimulation for the Treatment of Alcohol Addiction
nct_id: NCT05738174
overall_status: RECRUITING
phase: NA
sponsor: Berthold Langguth, MD, Ph.D.
study_type: INTERVENTIONAL
primary_condition: Alcohol Dependence
countries: Germany
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05738174.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05738174"
ct_last_update_post_date: 2025-09-19
last_seen_at: "2026-05-12T06:05:07.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# High-dose Accelerated Theta Burst Stimulation for the Treatment of Alcohol Addiction

**Official Title:** Theta Burst Zur Behandlung Der Alkoholabhängigkeit

**NCT ID:** [NCT05738174](https://clinicaltrials.gov/study/NCT05738174)

## Key Facts

- **Status:** RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 72
- **Lead Sponsor:** Berthold Langguth, MD, Ph.D.
- **Conditions:** Alcohol Dependence
- **Start Date:** 2023-03-01
- **Completion Date:** 2026-02-28
- **CT.gov Last Update:** 2025-09-19

## 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).

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **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:

* 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)
```

## Arms

- **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
- **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

## Interventions

- **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

- **Craving visual analoge scale** _(time frame: one week)_ — alcohol craving according to visual analog scale (range: 0-100; higher values = worse outcome)

## 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)_

## Locations (1)

- Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.department of psychiatry and psychotherapy, university of regensburg|regensburg||germany` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT05738174*  
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