Alcohol Dependence
Conditions
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).
Interventions
DEVICEhigh-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
DEVICEsham 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
Sponsors
Berthold Langguth, MD, Ph.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Craving visual analoge scale | one week | alcohol craving according to visual analog scale (range: 0-100; higher values = worse outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| relapse (number of patients with alcohol relapse) | 13 weeks | number of patients with alcohol relapse |
| heavy drinking days | 13 weeks | number of heavy drinking days (four drinks for female and five drinks for male) |
| 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) |
| 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) |
| 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) |
Countries
Germany
Contacts
Primary ContactMartin Schecklmann, Prof.
Backup ContactJohannes Huebner
Outcome results
None listed