TBA: High-dose Accelerated Theta Burst Stimulation for the Treatment of Alcohol Addiction
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: intermittent theta burst stimulation (iTBS) 1800 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
1800 pulses of iTBS per session with five sessions per day applied at five days (Monday-Friday) with 120% resting motor threshold
|
| Sham Comparator: sham treatment 1800 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
1800 pulses of iTBS per session with five sessions per day applied at five days (Monday-Friday) with 120% resting motor threshold with angled coil
|
Outcome Measures
Primary Outcome Measures
- Craving visual analoge scale [one week]
alcohol craving according to visual analog scale (range: 0-100; higher values = worse outcome)
Secondary Outcome Measures
- Craving visual analoge scale [13 weeks]
alcohol craving according to visual analog scale (range: 0-100; higher values = worse outcome)
- 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)
- 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)
- World Health Organisation quality of life bref [13 weeks]
World Health Organisation quality of life bref (range: 4-20; lower values = worse outcome)
Eligibility Criteria
Criteria
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
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participation in other trials during treatment
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pregnancy or breatfeeding
-
positive breath test for alcohol
-
legal care and placement in a psychiatric hospital
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co-medication with disulfiram, acamprosate, topiramate, baclofen, naltrexone, or nalmefene
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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)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Berthold Langguth, MD, Ph.D.
Investigators
- Principal Investigator: Berthold Langguth, University Hospital of Regensburg, Department of Psychiatry and Psychotherapy at the Bezirksklinikum
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 23-3261-101