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

Berthold Langguth, MD, Ph.D.

Status: Enrolling

Conditions: Alcohol Dependence

Treatments: Device: high-dose accelerated intermittent theta burst stimulation; Device: sham high-dose accelerated intermittent theta burst stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05738174

23-3261-101

Details and patient eligibility

About

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).

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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72 participants in 2 patient groups

intermittent theta burst stimulation (iTBS)

Experimental group

Description:

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

Treatment:

Device: high-dose accelerated intermittent theta burst stimulation

sham treatment

Sham Comparator group

Description:

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:

Device: sham high-dose accelerated intermittent theta burst stimulation