NCT06959342

Brief Summary

The aim of this project is to investigate the potential of transcranial direct current stimulation (tDCS) to reduce cognitive deficits and substance craving in individuals with substance use disorders (SUD), with a focus on alcohol use disorder (AUD). Patients of any gender between the ages of 18 and 65 are examined who are in our inpatient and day clinic settings for a standard detoxification treatment program. As there are conflicting findings regarding the effective settings for tDCS as an adjunctive treatment in SUD (e.g., effects on inhibitory control seem to be sensitive to current direction), the aim is to examine and compare three different active tDCS conditions, a sham tDCS condition (placebo), inhibition training, and a control group of patients receiving only standard detoxification treatment. The aim is to identify the optimal electrode placement and current direction to positively influence both inhibitory control and craving, leading to improved treatment outcomes such as longer abstinence periods or reduced substance use after relapse.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Sep 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Sep 2024Sep 2027

Study Start

First participant enrolled

September 23, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 6, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

June 4, 2025

Status Verified

May 1, 2025

Enrollment Period

2.5 years

First QC Date

April 2, 2025

Last Update Submit

May 28, 2025

Conditions

Alcohol Use DisorderSubstance Use Disorders

Keywords

Transcranial Direct Current StimulationtDCSInhibition TrainingElectroencephalographyEEGInhibitory ControlWorking MemoryCraving

Outcome Measures

Primary Outcomes (3)

  • Inhibitory Control (Go/No-Go Task)

    Change in performance in a modified Go/No-Go task. Measures inhibitory control under varying working memory loads.

    intervention day 1 (T1), intervention day 5 (T5), follow-up after 12 weeks (T8)

  • Inhibitory Control (EEG)

    Change in event-related potentials (ERPs), specifically the P300 and N200 components, measured by EEG during Go-/NO-GO task (32 channels with active electrodes, mBrainTrain, Belgrade, Serbia); sampling rate 1000Hz, filtered between 0.016-1000Hz, programmed in Presentation® software (Neurobehavioral Systems, Inc., Berkeley, CA, USA).

    intervention day 1 (T1), intervention day 5 (T5), follow-up after 12 weeks (T8)

  • Craving

    Change in subjective craving according to Alcohol Urge Questionnaire and craving scale. Alcohol Urge Questionnaire: 7-item Likert scale ranging from "strongly disagree" to "strongly agree"). A total score is calculated by averaging the scores for each item. Higher scores indicate stronger craving. Craving scale: Craving from 0-100%. Higher scores indicate stronger cravings.

    intervention day 1 and 5 (T1, T5), follow-up after 4 weeks (T6), follow-up after 8 weeks (T7), follow-up after 12 weeks (T8), follow-up after 24 weeks (T9)

Secondary Outcomes (1)

  • Relapse/Alcohol Use

    intervention day 1 and 5 (T1, T5), follow-up after 4 weeks (T6), follow-up after 8 weeks (T7), follow-up after 12 weeks (T8), follow-up after 24 weeks (T9)

Study Arms (6)

right dlPFC

EXPERIMENTAL

tDCS anodal electrode over the right dlPFC (position F4, EEG cap 10/20 system), cathodal electrode over the left dlPFC (position F3, EEG cap 10/20 system).

Device: Transcranial direct current stimulation (tDCS)

left dlPFC

ACTIVE COMPARATOR

tDCS anodal electrode over the left dlPFC (position F3, EEG cap 10/20 system), cathodal electrode over the right dlPFC (position F4, EEG cap 10/20 system).

Device: Transcranial direct current stimulation (tDCS)

Occipital Cortex

ACTIVE COMPARATOR

tDCS anodal electrode over the occipital cortex (position O1, EEG cap 10/20 system), cathodal electrode over position Cz (EEG cap 10/20 system).

Device: Transcranial direct current stimulation (tDCS)

Sham tDCS

SHAM COMPARATOR

tDCS anodal electrode over the right dlPFC (position F4, EEG cap 10/20 system), cathodal electrode over the left dlPFC (position F3, EEG cap 10/20 system). The current is ramped up from 0.3mA to initially 2mA (0.1mA/s) and then immediately ramped down.

Device: Transcranial direct current stimulation (tDCS)

Computerized Inhibition Training

ACTIVE COMPARATOR

Standardized computerized inhibition training using a go-/no-go-task with individually adapted, substance-related stimuli (wine, beer, spirits).

Behavioral: Inhibition Training

Treatment as Usual

NO INTERVENTION

Patients only receive standard treatment in clinic (qualified detoxification program).

Interventions

Transcranial direct current stimulation (tDCS)DEVICE

tDCS sessions on five consecutive days for 20 minutes.

Also known as: Sooma Medical
Occipital CortexSham tDCSleft dlPFCright dlPFC
Inhibition TrainingBEHAVIORAL

Computerized Training of inhibitory control (Go-/No-Go task with pictures of preferred alcohol) on five consecutive days.

Computerized Inhibition Training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • main diagnosis: alcohol use disorder according to DSM-5
  • patients of any gender aged 18 to 65
  • normal vision or correctable visual impairment.
  • sufficient ability to communicate verbally and in writing
  • ability to give fully informed consent after reviewing thorough written information

You may not qualify if:

  • withdrawal of consent
  • severe internal, neurological, or psychiatric comorbidities (e.g., lifetime schizophrenia, bipolar disorder, or other severe mental disorders according to ICD-10 and DSM-5, such as severe depression or PTSD within the last 12 months).
  • severe withdrawal symptoms (CIWA-R \> 7)
  • alcohol intoxication (breath alcohol concentration \> 0 ‰)
  • Pharmacotherapy with psychoactive substances within the last 14 days (exceptions: clomethiazole or benzodiazepines used in withdrawal treatment, provided they were discontinued at least 3 days prior; antidepressants or anxiolytics taken at stable doses).
  • drug or alcohol use within the last 7 days
  • for women: pregnancy
  • suicidal tendencies or danger to others

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Central Institute of Mental Health

Mannheim, 68159, Germany

RECRUITING

Psychiatrisches Zentrum Nordbaden (Psychiatric Center Nordbaden)

Wiesloch, 69168, Germany

NOT YET RECRUITING

Related Publications (3)

  • Stock AK, Riegler L, Chmielewski WX, Beste C. Paradox effects of binge drinking on response inhibition processes depending on mental workload. Arch Toxicol. 2016 Jun;90(6):1429-36. doi: 10.1007/s00204-015-1565-y. Epub 2015 Jul 1.

    PMID: 26126633BACKGROUND

  • Stein M, Soravia LM, Tschuemperlin RM, Batschelet HM, Jaeger J, Roesner S, Keller A, Gomez Penedo JM, Wiers RW, Moggi F. Alcohol-specific inhibition training in patients with alcohol use disorder: a multi-centre, double-blind randomized clinical trial examining drinking outcome and working mechanisms. Addiction. 2023 Apr;118(4):646-657. doi: 10.1111/add.16104. Epub 2023 Jan 3.

    PMID: 36468408BACKGROUND

  • Vollstadt-Klein S, Turkmen C, Grundinger N, Wieland A, Aggensteiner PM, Stock AK, Stein M, Moggi F, Bublatzky F, Kiefer F, Link T, Gerhardt S. Modification of inhibitory control and craving through transcranial direct current stimulation as an add-on treatment for substance use disorder: protocol for a randomized controlled study. BMC Psychol. 2025 Oct 13;13(1):1132. doi: 10.1186/s40359-025-03506-1.

    PMID: 41084082DERIVED

MeSH Terms

Conditions

AlcoholismSubstance-Related Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Central Study Contacts

Sabine Vollstädt-Klein, PhD

CONTACT

+4962117033912Sabine.Vollstaedt-Klein@zi-mannheim.de

Sarah Gerhardt, PhD

CONTACT

+4962117033927Sarah.Gerhardt@zi-mannheim.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single blinding of the tDCS stimulation groups: Participants do not receive any information about electrode placement or active vs. sham condition.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2025

First Posted

May 6, 2025

Study Start

September 23, 2024

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

June 4, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)