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

Berthold Langguth, MD, Ph.D.72 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Alcohol Dependence

Interventions

high-dose accelerated intermittent theta burst stimulationDEVICE

1200 pulses of iTBS per session with five sessions per day applied at five days (Monday-Friday) with 120% resting motor threshold

sham high-dose accelerated intermittent theta burst stimulationDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Locations (1)

Department of Psychiatry and Psychotherapy, University of Regensburg

Regensburg, Germany

RECRUITING

Outcomes

Primary Outcomes

Craving visual analoge scale

alcohol craving according to visual analog scale (range: 0-100; higher values = worse outcome)

Time frame: one week

Secondary Outcomes

Craving visual analoge scale

alcohol craving according to visual analog scale (range: 0-100; higher values = worse outcome)

Time frame: 13 weeks

relapse (number of patients with alcohol relapse)

number of patients with alcohol relapse

Time frame: 13 weeks

heavy drinking days

number of heavy drinking days (four drinks for female and five drinks for male)

Time frame: 13 weeks

abstinence confidence

abstinence confidence (Kurzfragebogen zur Abstinenzzuversicht KAZ-35; only available in German; range: 0-100%; higher values = worse outcome)

Time frame: 13 weeks

degree of dependence

degree of dependence according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) (range: mild, moderate, severe)

Time frame: 13 weeks

Fagerström Test for Nicotine Dependence

Fagerström Test for Nicotine Dependence (range: 0-10; higher values = worse outcome)

Time frame: 13 weeks

major depression inventory

Major Depression Inventory (range: 0-50; higher values = worse outcome)

Central Contacts

Martin Schecklmann, Prof.

CONTACT

+49-941-941-1256 martin.schecklmann@medbo.com

Johannes Huebner

CONTACT

+49-941-941-0 johannes.huebner@medbo.de

Data from ClinicalTrials.gov

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