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

Alcohol Dependence Clinical Trial

— TBA  

Official title:

Theta Burst Zur Behandlung Der Alkoholabhängigkeit

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05738174
• Other study ID #: 23-3261-101
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: March 2023
• Source: University of Regensburg
• Contact: Martin Schecklmann, Prof.
• Phone: +49-941-941-1256
• Email: martin.schecklmann[@]medbo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Device:
• 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
• sham 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

Country	Name	City	State
Germany	Department of Psychiatry and Psychotherapy, University of Regensburg	Regensburg

Sponsors (1)

Lead Sponsor	Collaborator
Berthold Langguth, MD, Ph.D.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Craving visual analoge scale	alcohol craving according to visual analog scale (range: 0-100; higher values = worse outcome)	one week
Secondary	Craving visual analoge scale	alcohol craving according to visual analog scale (range: 0-100; higher values = worse outcome)	13 weeks
Secondary	relapse (number of patients with alcohol relapse)	number of patients with alcohol relapse	13 weeks
Secondary	heavy drinking days	number of heavy drinking days (four drinks for female and five drinks for male)	13 weeks
Secondary	abstinence confidence	abstinence confidence (Kurzfragebogen zur Abstinenzzuversicht KAZ-35; only available in German; range: 0-100%; higher values = worse outcome)	13 weeks
Secondary	degree of dependence	degree of dependence according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) (range: mild, moderate, severe)	13 weeks
Secondary	Fagerström Test for Nicotine Dependence	Fagerström Test for Nicotine Dependence (range: 0-10; higher values = worse outcome)	13 weeks
Secondary	major depression inventory	Major Depression Inventory (range: 0-50; higher values = worse outcome)	13 weeks
Secondary	World Health Organisation quality of life bref	World Health Organisation quality of life bref (range: 4-20; lower values = worse outcome)	13 weeks