High-dose theta burst stimulation for alcohol addiction treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial involves a two-arm randomized placebo-controlled design where 72 patients with alcohol addiction will receive high-dose accelerated intermittent theta burst stimulation (TBS) or a sham treatment. The aim is to evaluate the efficacy of TBS in reducing alcohol dependence as defined by ICD-10 criteria. Participants must be German-speaking residents of Germany, aged 18-65, and provide written informed consent. The study will assess the impact of this innovative treatment approach on patients' desire to reduce or abstain from alcohol consumption.

Why it matters

Who can join: the full rules

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)

Where it's running

• Department of Psychiatry and Psychotherapy, University of Regensburg
  Regensburg, Germany Recruiting

Study contacts

• Principal investigator: Berthold Langguth — University Hospital of Regensburg, Department of Psychiatry and Psychotherapy at the Bezirksklinikum
• Study coordinator: Martin Schecklmann, Prof.
• Email: martin.schecklmann@medbo.com
• Phone: +49-941-941-1256

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.