Combining neuromodulation and mindfulness for alcohol dependence
Neuromodulation and Mindfulness as Therapeutic Treatment in Detoxified Patients With AUD
This study is testing if combining a special nerve stimulation technique with mindfulness meditation can help people recovering from alcohol dependence reduce cravings and improve their chances of staying sober.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 1 site (Berlin, State of Berlin) |
| Trial ID | NCT06308484 on ClinicalTrials.gov |
What this trial studies
This study aims to integrate transcutaneous vagus nerve stimulation (tVNS) and mindfulness meditation within a structured mindfulness-based relapse prevention (MBRP) program for patients recovering from alcohol dependence. The researchers will evaluate whether neuromodulation enhances the effectiveness of mindfulness practices compared to mindfulness alone. They will measure changes in drinking behavior, cravings, and abstinence rates for up to three months post-treatment, while also investigating the role of brain oscillations in cognitive control during meditation exercises. The study focuses on detoxified alcohol-dependent individuals who have maintained abstinence for varying durations.
Who should consider this trial
Good fit: Ideal candidates are detoxified alcohol-dependent patients who have been abstinent for 3 days to 12 months.
Not a fit: Patients with current substance use disorders, severe mental health conditions, or neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve relapse prevention strategies for individuals recovering from alcohol dependence.
How similar studies have performed: While the integration of neuromodulation with mindfulness is a novel approach, similar studies have shown promise in enhancing therapeutic outcomes in various conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Alcohol Dependence (ICD-10) * abstinence between 3 days and 12 months Exclusion Criteria: * current (last 12 months) substance use disorder/dependence * neurological disorders (e.g. epilepsy, neuropathy, multiple sclerosis) * current severe major depressive disorder, manic episode or schizophreniform disorder * intake of anticonvulsive or high-potency antipsychotic medication
Where this trial is running
Berlin, State of Berlin
- Charité - Berlin University of Medicine — Berlin, State of Berlin, Germany (Recruiting)
Study contacts
- Principal investigator: Anne Beck, Prof. Dr. — Faculty of Health Sciences, Health and Medical University, University of Potsdam, Potsdam, Germany
- Study coordinator: Annika Rosenthal
- Email: annika.rosenthal@charite.de
- Phone: 030 450 517040
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.