Recruiting NCT05738174
High-dose Accelerated Theta Burst Stimulation for the Treatment of Alcohol Addiction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: high-dose accelerated intermittent theta burst stimulation, sham high-dose accelerated intermittent theta burst stimulation.
- Who it may be relevant to
- Registry conditions: Alcohol Dependence. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Theta Burst Zur Behandlung Der Alkoholabhängigkeit
Overview
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
- Device 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 - Device 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
- Craving visual analoge scale [Time frame: one week]
Secondary outcome measures (8)
- Craving visual analoge scale [Time frame: 13 weeks]
- relapse (number of patients with alcohol relapse) [Time frame: 13 weeks]
- heavy drinking days [Time frame: 13 weeks]
- abstinence confidence [Time frame: 13 weeks]
- degree of dependence [Time frame: 13 weeks]
- Fagerström Test for Nicotine Dependence [Time frame: 13 weeks]
- major depression inventory [Time frame: 13 weeks]
- World Health Organisation quality of life bref [Time frame: 13 weeks]
Eligibility 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
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- Department of Psychiatry and Psychotherapy, University of Regensburg — Regensburg
Identifiers
NCT: NCT05738174 · 23-3261-101