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Combining Cognitive Training With tDCS to Enhance Memory Inhibition in Young Binge Drinkers

U

University of Minho

Status

Completed

Conditions

Binge Drinking

Treatments

Device: Sham tDCS
Behavioral: Active CT
Behavioral: Sham CT
Device: Active tDCS

Study type

Interventional

Funder types

Other

Identifiers

NCT05237414
CE.CSH 078/2018 (Other Identifier)
PTDC/PSI-ESP/28672/2017 (Other Grant/Funding Number)

Details and patient eligibility

About

This study protocol aims to examine the behavioral and electroencephalographic (EEG) correlates of memory inhibition (MI) among college binge drinkers (BDs). A second objective is to evaluate an alcohol-specific MI training protocol using cognitive training (CT) and transcranial direct current stimulation (tDCS) while its effects on behavioral and EEG outcomes are assessed. Along with poor MI abilities, we hypothesized that BDs would show alterations in the amplitude of several event-related potentials (ERPs) linked to MI (e.g., N2 and late parietal positivity) as well as abnormal functional connectivity (FC) patterns within/between regions associated with MI (e.g., dorsolateral prefrontal cortex [DLPFC] and hippocampal/parahippocampal regions). Results should also demonstrate the effectiveness of the training protocol, with BDs exhibiting an improved capacity to suppress alcohol-related memories after both combined and cognitive MI training, along with a significant reduction in alcohol use and craving in the short/medium-term. Furthermore, this protocol should also lead to significant modifications in the ERP and FC patterns, reflecting stronger MI capabilities and reduced alcohol cue reactivity in trained BD participants.

Full description

The present study protocol aims to examine the behavioral and EEG correlates of MI, specifically those related to the suppression of alcohol-related memories, among young BDs. For this purpose, 45 BDs and 45 age-matched non/low-drinkers (N/LDs) will be assessed by EEG while performing the Think/No-Think Alcohol (TNTA) task, a paradigm that evaluates alcohol-related MI (Pre-training EEG assessment). The TNTA is divided into three phases: 1) the Learning phase, 2) the Think/No-Think (TNT) phase and 3) the Memory-Test phase. During the learning phase, participants will be asked to associate and memorize 36 pairs of neutral objects + alcoholic/non-alcoholic pictures. Then, only the neutral objects will be presented, and participants will have to try to remember the picture (alcoholic/non-alcoholic image) that was associated with this neutral object and answer three questions about the beverage depicted, the orientation of the picture and the number of people present in it. After the learning phase, the Think/No -Think phase will comprehend two conditions: in the Think condition (depicted in the neutral images with a green frame),participants are presented with the object and they will be instructed to "think of the previously learned alcoholic/non-alcoholic picture and keep it in mind during the entire presentation of the object". In the No-Think condition (depicted by neutral images with a red frame) they will be asked "not to let the previously associated picture enter your consciousness". In the memory test phase, the 36 neutral images will be presented again, including the 12 neutral objects of the baseline condition that were not presented in the TNT phase. Participants will be asked to recall - answering the same three questions of the learning phase - the image (alcoholic/non-alcoholic) that was initially associated with the neutral object.

During this pre-training session, psychological (i.e., craving levels), behavioral (i.e., alcohol consumption, recall accuracy and MI performance), and neurofunctional (i.e., ERPs and FC) variables will be assessed.

In addition, this study aims to evaluate an alcohol-specific MI intervention protocol using cognitive training and tDCS while its effects on behavioral and EEG outcomes are assessed. For that, BDs will be randomly assigned to one of three training groups: combined intervention (active CT and active tDCS applied over the right DLPFC), cognitive intervention (active CT and sham tDCS), or control intervention (sham CT and sham tDCS). Training will occur in three consecutive days (i.e., Tuesday, Wednesday, and Thursday), in three sessions. MI will be re-assessed in BDs after the last training session through a post-training EEG assessment. N/LDs will only perform the pre-training EEG assessment. Alcohol use and craving will also be measured both 10-days and 3-months post-training in order to monitor short- and medium-term effects of the MI training in the alcohol craving and consumption levels. Furthermore, behavioral and EEG data will be collected during the performance of an alcohol cue reactivity (ACR) task before and after the MI training sessions, in order to evaluate potential attentional bias towards alcoholic stimuli. Overall, this intervention protocol aims to investigate whether this training is able 1) to enhance MI capabilities and to reduce alcohol attentional bias, and 2) to decrease craving and/or alcohol use -monitoring up to three months after protocol implementation- in trained BD participants.

Enrollment

114 patients

Sex

All

Ages

18 to 24 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • College students
  • Age 18-24 years
  • Binge Drinkers: report (i) drinking 5 or more drinks on one occasion at least once a month, and (ii) drinking at a speed of at least two drinks per hour during these episodes (which brings blood alcohol concentration to 0.08 gram percent or above).
  • Non/Low-Drinkers: report (i) never drinking 5 or more drinks on one occasion and (ii) having an AUDIT score ≤ 4.

Exclusion criteria

  • Use of illegal drugs except cannabis (as determined by the Drug Use Disorders Identification Test-Extended [DUDIT-E; Berman, Bergman, Palmstierna & Schlyter, 2007);
  • Alcohol abuse (i.e., AUDIT ≥ 20);
  • Consumption of medical drugs with psychoactive effects (e.g., sedatives or anxiolytics) during the two weeks before the experiment;
  • Personal history of psychopathological disorders (according to DSM-V criteria);
  • History of traumatic brain injury or neurological disorder;
  • Family history of alcoholism or diagnosis of other substance abuse;
  • Occurrence of one or more episodes of loss of consciousness for more than 20 minutes;
  • Non-corrected sensory deficits;
  • Global Severity Index (GSI) > 90 (Symptom Checklist-90-Revised questionnaire [SCL-90-R]; Derogatis, 1983) or a score above 90 in at least two of the symptomatic dimensions.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

114 participants in 4 patient groups

Binge Drinkers with Combined Intervention (active CT + active tDCS)
Experimental group
Description:
Subjects will perform a variation of the TNTA task (Anderson \& Green, 2001; López-Caneda et al., 2019) to enhance the suppression of alcohol-related memories. The Learning phase will be composed of 2 blocks of 12-image pairs (as there is no a baseline block), and in the TNT phase, all the stimuli to be inhibited will be alcohol-related images. After the Learning Phase, active neuromodulation will be performed using tDCS. Twenty minutes of 2 mA direct current will be applied on the scalp using a saline-soaked pair of 35 cm2 surface sponge electrodes, through an Eldith DC Stimulator Plus (Neuroconn, Germany). To stimulate the right DLPFC, the anodal electrode will be placed over F4 according to the 10-20 international system for EEG electrode placement. The cathode electrode will be over the contralateral supraorbital area. The current fade in for 15 seconds, is constant at 2 mA for 20 minutes, and then fade out for 15 seconds.
Treatment:
Behavioral: Active CT
Device: Active tDCS
Binge Drinkers with Cognitive Intervention (active CT + sham tDCS)
Experimental group
Description:
Subjects perform the variation of the TNTA task for active CT. After the Learning Phase, sham neuromodulation is performed using the same montage of the active tDCS. However, the electric current fade in during 15 seconds until reaching 2 mA, then is constant at 2 mA for 15 seconds and fade out for 15 seconds. There is no current for the rest of the time.
Treatment:
Behavioral: Active CT
Device: Sham tDCS
Binge Drinkers with Control Intervention (sham CT + sham tDCS)
Sham Comparator group
Description:
Subjects will perform a variation of the TNTA task, where the Learning phase also have only two blocks of 12-image pairs. However, in this case the TNT phase is replaced by a Forced-Choice Reaction Time (FCRT) task, during which the participants only must categorize alcoholic and non-alcoholic images answering to the question "What type of beverage was there in the image?" (answer: "Alcoholic drink" or "Non-alcoholic drink"); thus, they do not have to inhibit the memories related to the alcoholic images. During this phase, sham neuromodulation will be performed using the same montage of the active tDCS. The electric current fade in during 15 seconds until reaching 2 mA, then is constant at 2 mA for 15 seconds and fade out for 15 seconds, while a sham memory inhibition CT is performed.
Treatment:
Device: Sham tDCS
Behavioral: Sham CT
Non/Low-Drinkers
No Intervention group
Description:
No intervention.

Trial documents
3

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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