Health TrialsbyHealthPanel

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

ConditionAlcohol Dependence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBerthold Langguth, MD, Ph.D.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

alchohol dependence according to ICD-10 (F10.2)

desire to reduce or abstain from alcohol drinking

male or female

18-65 years

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • high-dose accelerated intermittent theta burst stimulation

    Device

    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 stimulation

    Device

    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

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: intermittent theta burst stimulation (iTBS)Experimental treatment 1 intervention
Group B: sham treatmentSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Craving visual analoge scale

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

Time frame
one week

Secondary outcomes

1

Craving visual analoge scale

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

Time frame
13 weeks
2

relapse (number of patients with alcohol relapse)

number of patients with alcohol relapse

Time frame
13 weeks
3

heavy drinking days

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

Time frame
13 weeks
4

abstinence confidence

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

Time frame
13 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Berthold Langguth, MD, Ph.D.

Lead sponsor

University of Regensburg

Sponsor institution

Source ClinicalTrials.gov
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