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

NCT ID: NCT05738174

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2026-02-28

Brief Summary

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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).

Detailed Description

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Conditions

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Alcohol Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

high-dose accelerated intermittent theta burst stimulation

Intervention Type DEVICE

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

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

Group Type SHAM_COMPARATOR

sham high-dose accelerated intermittent theta burst stimulation

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Berthold Langguth, MD, Ph.D.

OTHER

Sponsor Role lead

Responsible Party

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Berthold Langguth, MD, Ph.D.

Prof. Dr.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Berthold Langguth

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Regensburg, Department of Psychiatry and Psychotherapy at the Bezirksklinikum

Locations

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Department of Psychiatry and Psychotherapy, University of Regensburg

Regensburg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Martin Schecklmann, Prof.

Role: CONTACT

+49-941-941-1256

Johannes Huebner

Role: CONTACT

+49-941-941-0

Facility Contacts

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Berthold Langguth

Role: primary

+49-941-941-2099

Other Identifiers

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23-3261-101

Identifier Type: -

Identifier Source: org_study_id

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