Modification of Inhibitory Control and Craving Through Transcranial Direct Current Stimulation (tDCS) as an Add-On Treatment for Substance Use Disorder

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCentral Institute of Mental Health, Mannheim

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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).

Exclusion criteria for an EEG/tDCS examination (e.g. metal implants in the head, epilepsy, etc.)

severe withdrawal symptoms (CIWA-R > 7)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transcranial direct current stimulation (tDCS)

    Device

    tDCS sessions on five consecutive days for 20 minutes.

  • Inhibition Training

    Behavioral

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

Treatment groups

162 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: right dlPFCExperimental treatment 1 intervention
Group B: left dlPFCActive comparator 1 intervention
Group C: Occipital CortexActive comparator 1 intervention
Group D: Sham tDCSSham comparator 1 intervention
Group E: Computerized Inhibition TrainingActive comparator 1 intervention
Group F: Treatment as UsualNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Inhibitory Control (Go/No-Go Task)

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

Time frame
intervention day 1 (T1), intervention day 5 (T5), follow-up after 12 weeks (T8)
2

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).

Time frame
intervention day 1 (T1), intervention day 5 (T5), follow-up after 12 weeks (T8)
3

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.

Time frame
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

Change in number of drinking days, number of abstinent days, number of days with more than 48/60g (women/men) of alcohol, cumulative amount of alcohol in grams.

Time frame
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)

Other outcomes

Sponsors and contacts

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