RecruitingNot ApplicableNCT05738174

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

Theta Burst Zur Behandlung Der Alkoholabhängigkeit


Sponsor

Berthold Langguth, MD, Ph.D.

Enrollment

72 participants

Start Date

Mar 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria6

  • alchohol dependence according to ICD-10 (F10.2)
  • desire to reduce or abstain from alcohol drinking
  • male or female
  • -65 years
  • residency in Germany, German speaking
  • written informed consent

Exclusion Criteria11

  • 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)

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Interventions

DEVICEhigh-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

DEVICEsham 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


Locations(1)

Department of Psychiatry and Psychotherapy, University of Regensburg

Regensburg, Germany

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NCT05738174


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