High-dose theta burst stimulation for alcohol addiction treatment
Theta Burst Zur Behandlung Der Alkoholabhängigkeit
This study tests whether a new brain stimulation treatment can help people with alcohol addiction reduce their cravings and dependence on alcohol.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Regensburg Academic / other |
| Locations | 1 site (Regensburg) |
| Trial ID | NCT05738174 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are German-speaking adults aged 18-65 who are diagnosed with alcohol dependence and wish to reduce or stop drinking.
Not a fit: Patients with severe psychiatric conditions or those currently using certain medications for alcohol dependence may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel non-invasive option for individuals struggling with alcohol addiction.
How similar studies have performed: While the approach of using theta burst stimulation is relatively novel, similar studies in other areas of mental health have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Regensburg
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.