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

Not Applicable

Recruiting

• Conditions: Alcohol Dependence
• Interventions: Device: high-dose accelerated intermittent theta burst stimulation; Device: sham high-dose accelerated intermittent theta burst stimulation

• Registration Number: NCT05738174
• Lead Sponsor: Berthold Langguth, MD, Ph.D.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-07
• Study First Submitted QC: 2023-02-20
• Study First Posted: 2023-02-21
• Study Start: 2023-03-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-15
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intermittent theta burst stimulation (iTBS)	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
sham treatment	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

Primary Outcome Measures

Name	Time	Method
Craving visual analoge scale	one week	alcohol craving according to visual analog scale (range: 0-100; higher values = worse outcome)

Secondary Outcome Measures

Name	Time	Method
relapse (number of patients with alcohol relapse)	13 weeks	number of patients with alcohol relapse
abstinence confidence	13 weeks	abstinence confidence (Kurzfragebogen zur Abstinenzzuversicht KAZ-35; only available in German; range: 0-100%; higher values = worse outcome)
Craving visual analoge scale	13 weeks	alcohol craving according to visual analog scale (range: 0-100; higher values = worse outcome)
heavy drinking days	13 weeks	number of heavy drinking days (four drinks for female and five drinks for male)
World Health Organisation quality of life bref	13 weeks	World Health Organisation quality of life bref (range: 4-20; lower values = worse outcome)
degree of dependence	13 weeks	degree of dependence according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) (range: mild, moderate, severe)
Fagerström Test for Nicotine Dependence	13 weeks	Fagerström Test for Nicotine Dependence (range: 0-10; higher values = worse outcome)
major depression inventory	13 weeks	Major Depression Inventory (range: 0-50; higher values = worse outcome)

Trial Locations

Locations (1)

Department of Psychiatry and Psychotherapy, University of Regensburg; 🇩🇪 Regensburg, Germany