High-dose Accelerated Theta Burst Stimulation for the Treatment of Alcohol Addiction

Launched by BERTHOLD LANGGUTH, MD, PH.D. · Feb 20, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for people struggling with alcohol addiction. The study is testing a method called high-dose accelerated intermittent theta burst stimulation (TBS) to see if it can help individuals reduce their alcohol consumption or stop drinking altogether. The trial will involve 72 participants who are randomly assigned to receive either the TBS treatment or a placebo (a treatment with no active ingredients) to compare the effects.

To be eligible for the trial, participants must be between 18 and 65 years old, live in Germany, and speak German. They also need to have a diagnosis of alcohol dependence and a desire to cut down or stop drinking. However, certain conditions may exclude someone from participating, such as having metal implants like a pacemaker, serious neurological issues, or being pregnant. If selected, participants can expect to receive this innovative treatment and will be closely monitored throughout the study. This trial is currently recruiting, and it may provide valuable insights into new options for treating alcohol addiction.

Gender

ALL

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)