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

Primary Purpose

Alcohol Dependence

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
high-dose accelerated intermittent theta burst stimulation
sham high-dose accelerated intermittent theta burst stimulation
Sponsored by
Berthold Langguth, MD, Ph.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Department of Psychiatry and Psychotherapy, University of RegensburgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

intermittent theta burst stimulation (iTBS)

sham treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 7, 2023
Last Updated
March 24, 2023
Sponsor
Berthold Langguth, MD, Ph.D.
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1. Study Identification

Unique Protocol Identification Number
NCT05738174
Brief Title
High-dose Accelerated Theta Burst Stimulation for the Treatment of Alcohol Addiction
Acronym
TBA
Official Title
Theta Burst Zur Behandlung Der Alkoholabhängigkeit
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Berthold Langguth, MD, Ph.D.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intermittent theta burst stimulation (iTBS)
Arm Type
Experimental
Arm Description
1200 pulses of iTBS per session with five sessions per day applied at five days (Monday-Friday) with 120% resting motor threshold
Arm Title
sham treatment
Arm Type
Sham Comparator
Arm 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
Intervention Type
Device
Intervention Name(s)
high-dose accelerated intermittent theta burst stimulation
Intervention Description
1200 pulses of iTBS per session with five sessions per day applied at five days (Monday-Friday) with 120% resting motor threshold
Intervention Type
Device
Intervention Name(s)
sham high-dose accelerated intermittent theta burst stimulation
Intervention 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
Primary Outcome Measure Information:
Title
Craving visual analoge scale
Description
alcohol craving according to visual analog scale (range: 0-100; higher values = worse outcome)
Time Frame
one week
Secondary Outcome Measure Information:
Title
Craving visual analoge scale
Description
alcohol craving according to visual analog scale (range: 0-100; higher values = worse outcome)
Time Frame
13 weeks
Title
relapse (number of patients with alcohol relapse)
Description
number of patients with alcohol relapse
Time Frame
13 weeks
Title
heavy drinking days
Description
number of heavy drinking days (four drinks for female and five drinks for male)
Time Frame
13 weeks
Title
abstinence confidence
Description
abstinence confidence (Kurzfragebogen zur Abstinenzzuversicht KAZ-35; only available in German; range: 0-100%; higher values = worse outcome)
Time Frame
13 weeks
Title
degree of dependence
Description
degree of dependence according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) (range: mild, moderate, severe)
Time Frame
13 weeks
Title
Fagerström Test for Nicotine Dependence
Description
Fagerström Test for Nicotine Dependence (range: 0-10; higher values = worse outcome)
Time Frame
13 weeks
Title
major depression inventory
Description
Major Depression Inventory (range: 0-50; higher values = worse outcome)
Time Frame
13 weeks
Title
World Health Organisation quality of life bref
Description
World Health Organisation quality of life bref (range: 4-20; lower values = worse outcome)
Time Frame
13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Schecklmann, Prof.
Phone
+49-941-941-1256
Email
martin.schecklmann@medbo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Johannes Huebner
Phone
+49-941-941-0
Email
johannes.huebner@medbo.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berthold Langguth
Organizational Affiliation
University Hospital of Regensburg, Department of Psychiatry and Psychotherapy at the Bezirksklinikum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry and Psychotherapy, University of Regensburg
City
Regensburg
ZIP/Postal Code
93055
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Berthold Langguth
Phone
+49-941-941-2099
Email
berthold.langguth@medbo.de

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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