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

Study Overview
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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).

Official Title
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Theta Burst Zur Behandlung Der Alkoholabhängigkeit

Conditions
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Alcohol Dependence

Intervention / Treatment
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* Device: high-dose accelerated intermittent theta burst stimulation
* Device: sham high-dose accelerated intermittent theta burst stimulation


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intermittent theta burst stimulation (iTBS)<br>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<br>* 1200 pulses of iTBS per session with five sessions per day applied at five days (Monday-Friday) with 120% resting motor threshold<br>|
| Sham Comparator: sham treatment<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Craving visual analoge scale | alcohol craving according to visual analog scale (range: 0-100; higher values = worse outcome) | one week | 

Secondary Outcome Measures

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