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

NCT ID: NCT05237414

Last Updated: 2022-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-05

Study Completion Date

2022-08-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Binge Drinking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

BDs will be randomly distributed for one of three training conditions: Combined Training (i.e, active tDCS and active CT), Cognitive Training (i.e., sham tDCS and active CT), and Control (i.e., sham tDCS and sham CT).
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Binge Drinkers with Combined Intervention (active CT + active tDCS)

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.

Group Type EXPERIMENTAL

Active tDCS

Intervention Type DEVICE

20 minutes of 2.0 mA direct current applied over the right DLPFC

Active CT

Intervention Type BEHAVIORAL

Active memory inhibition CT (i.e., training of memory inhibition specifically for alcohol-related memories).

Binge Drinkers with Cognitive Intervention (active CT + sham tDCS)

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.

Group Type EXPERIMENTAL

Sham tDCS

Intervention Type DEVICE

15 seconds of 2.0 mA direct current applied over the right DLPFC

Active CT

Intervention Type BEHAVIORAL

Active memory inhibition CT (i.e., training of memory inhibition specifically for alcohol-related memories).

Binge Drinkers with Control Intervention (sham CT + sham tDCS)

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.

Group Type SHAM_COMPARATOR

Sham tDCS

Intervention Type DEVICE

15 seconds of 2.0 mA direct current applied over the right DLPFC

Sham CT

Intervention Type BEHAVIORAL

Sham memory inhibition CT (i.e., participants have to categorize alcoholic and non-alcoholic images but they do not have to inhibit the memories related to these images).

Non/Low-Drinkers

No intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Active tDCS

20 minutes of 2.0 mA direct current applied over the right DLPFC

Intervention Type DEVICE

Sham tDCS

15 seconds of 2.0 mA direct current applied over the right DLPFC

Intervention Type DEVICE

Active CT

Active memory inhibition CT (i.e., training of memory inhibition specifically for alcohol-related memories).

Intervention Type BEHAVIORAL

Sham CT

Sham memory inhibition CT (i.e., participants have to categorize alcoholic and non-alcoholic images but they do not have to inhibit the memories related to these images).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Minho

OTHER

Sponsor Role lead

Responsible Party

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Eduardo López-Caneda

Postdoctoral Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eduardo G. López-Caneda, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minho

Locations

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School of Psychology

Braga, , Portugal

Site Status

Countries

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Portugal

References

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Lopez-Caneda E, Crego A, Campos AD, Gonzalez-Villar A, Sampaio A. The Think/No-Think Alcohol Task: A New Paradigm for Assessing Memory Suppression in Alcohol-Related Contexts. Alcohol Clin Exp Res. 2019 Jan;43(1):36-47. doi: 10.1111/acer.13916. Epub 2018 Nov 25.

Reference Type BACKGROUND
PMID: 30375668 (View on PubMed)

Almeida-Antunes N, Anton-Toro L, Crego A, Rodrigues R, Sampaio A, Lopez-Caneda E. Trying to forget alcohol: Brain mechanisms underlying memory suppression in young binge drinkers. Prog Neuropsychopharmacol Biol Psychiatry. 2024 Aug 30;134:111053. doi: 10.1016/j.pnpbp.2024.111053. Epub 2024 Jun 11.

Reference Type DERIVED
PMID: 38871018 (View on PubMed)

Almeida-Antunes N, Vasconcelos M, Crego A, Rodrigues R, Sampaio A, Lopez-Caneda E. Forgetting Alcohol: A Double-Blind, Randomized Controlled Trial Investigating Memory Inhibition Training in Young Binge Drinkers. Front Neurosci. 2022 Jun 29;16:914213. doi: 10.3389/fnins.2022.914213. eCollection 2022.

Reference Type DERIVED
PMID: 35844233 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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CE.CSH 078/2018

Identifier Type: OTHER

Identifier Source: secondary_id

PTDC/PSI-ESP/28672/2017

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PTDC/PSI-ESP/28672/2017

Identifier Type: -

Identifier Source: org_study_id

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