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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Craving visual analoge scale | alcohol craving according to visual analog scale (range: 0-100; higher values = worse outcome) | one week |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin Schecklmann, Prof. | Contact | +49-941-941-1256 | martin.schecklmann@medbo.com | |
| Johannes Huebner | Contact | +49-941-941-0 | johannes.huebner@medbo.de |
| Name | Affiliation | Role |
|---|---|---|
| Berthold Langguth | University Hospital of Regensburg, Department of Psychiatry and Psychotherapy at the Bezirksklinikum | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry and Psychotherapy, University of Regensburg | Recruiting | Regensburg | 93055 | Germany |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| 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 |
|
| 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 |