NCT05237414

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

February 5, 2019

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 14, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2022

Completed
Last Updated

November 3, 2022

Status Verified

November 1, 2022

Enrollment Period

3.2 years

First QC Date

January 17, 2022

Last Update Submit

November 2, 2022

Conditions

Binge Drinking

Keywords

AlcoholCravingBinge DrinkingCollege StudentsMemory InhibitionAlcohol-Related MemoriesRandomized Controlled TrialIntervention ProtocolCognitive TrainingTranscranial Direct-Current Stimulation (tDCS)Electroencephalography (EEG)Event-Related Potentials (ERPs)Functional Connectivity

Outcome Measures

Primary Outcomes (37)

  • Behavioral Memory Inhibition Performance

    MI, specifically alcohol-related MI, will be assessed using the TNTA task. Percentage of correct responses (for Think, No-Think and Baseline items) in the TNTA task will be computed according to the following formula: ((number of correctly recalled items)/(number of previously learned items))×100. Correct responses correspond to the items learned during the learning phase and correctly recalled during the memory test phase.

    At baseline (pre-training)

  • Behavioral Memory Inhibition Performance

    MI, specifically alcohol-related MI, will be assessed using the TNTA task. Percentage of correct responses (for Think, No-Think and Baseline items) in the TNTA task will be computed according to the following formula: ((number of correctly recalled items)/(number of previously learned items))×100. Correct responses correspond to the items learned during the learning phase and correctly recalled during the memory test phase.

    1day after MI training

  • EEG correlates of Memory Inhibition Performance - N2 ERP component

    After EEG data collection, the mean amplitude of N2 component will be analyzed.

    At baseline (pre-training)

  • EEG correlates of Memory Inhibition Performance - N2 ERP component

    After EEG data collection, the mean amplitude of N2 component will be analyzed.

    1day after MI training

  • EEG correlates of Memory Inhibition Performance - LPP ERP component

    After EEG data collection, the mean amplitude of Late Parietal Positivity (LPP) will be analyzed.

    At baseline (pre-training)

  • EEG correlates of Memory Inhibition Performance - LPP ERP component

    After EEG data collection, the mean amplitude of Late Parietal Positivity (LPP) will be analyzed.

    1day after MI training

  • EEG correlates of Memory Inhibition Performance - Frontal slow wave (FSW) ERP component

    After EEG data collection, the mean amplitudes of FSW will be analyzed

    At baseline (pre-training)

  • EEG correlates of Memory Inhibition Performance - Frontal slow wave (FSW) ERP component

    After EEG data collection, the mean amplitudes of FSW will be analyzed

    1day after MI training

  • EEG correlates of Memory Inhibition Performance - Functional connectivity (FC)

    FC patterns within/between regions associated with MI (e.g., DLPFC and hippocampal/parahippocampal regions) will also be assessed.

    At baseline (pre-training)

  • EEG correlates of Memory Inhibition Performance - Functional connectivity (FC)

    FC patterns within/between regions associated with MI (e.g., DLPFC and hippocampal/parahippocampal regions) will also be assessed.

    1day after MI training

  • Alcohol Cue Reactivity - Emotional measures

    The reactivity to alcoholic cues will be assessed using the ACR task. The full task includes a total of 80 trials with 40 alcoholic and 40 non-alcoholic images obtained from the Amsterdam Beverage Picture Set (Pronk, van Deursen, Beraha, Larsen \& Wiers, 2015). The emotional responses for each image in terms of valence and arousal task, will be registered using the Self-Assessment Manikin (valence: from 1 = "very unpleasant" to 9 ="very pleasant"; arousal: from 1 = "not arousing" to 9 = "highly arousing") during the ACR task.

    At baseline (pre-training)

  • Alcohol Cue Reactivity - Emotional measures

    The reactivity to alcoholic cues will be assessed using the ACR task. The full task includes a total of 80 trials with 40 alcoholic and 40 non-alcoholic images obtained from the Amsterdam Beverage Picture Set (Pronk, van Deursen, Beraha, Larsen \& Wiers, 2015). The emotional responses for each image in terms of valence and arousal task, will be registered using the Self-Assessment Manikin (valence: from 1 = "very unpleasant" to 9 ="very pleasant"; arousal: from 1 = "not arousing" to 9 = "highly arousing") during the ACR task.

    1day after MI training

  • EEG correlates of Alcohol Cue Reactivity - P1 ERP component

    The reactivity to alcoholic cues will be assessed using the ACR task. The full task includes a total of 80 trials with 40 alcoholic and 40 non-alcoholic images obtained from the Amsterdam Beverage Picture Set. After EEG data collection, the mean amplitude of the P1 for alcoholic and non-alcoholic images of ACR task will be analyzed.

    At baseline (pre-training)

  • EEG correlates of Alcohol Cue Reactivity - P1 ERP component

    The reactivity to alcoholic cues will be assessed using the ACR task. The full task includes a total of 80 trials with 40 alcoholic and 40 non-alcoholic images obtained from the Amsterdam Beverage Picture Set. After EEG data collection, the mean amplitude of the P1 for alcoholic and non-alcoholic images of ACR task will be analyzed.

    1day after MI training

  • EEG correlates of Alcohol Cue Reactivity - N1 ERP component

    The reactivity to alcoholic cues will be assessed using the ACR task. The full task includes a total of 80 trials with 40 alcoholic and 40 non-alcoholic images obtained from the Amsterdam Beverage Picture Set. After EEG data collection, the mean amplitude of the N1 for alcoholic and non-alcoholic images of ACR task will be analyzed.

    Baseline (pre-training)

  • EEG correlates of Alcohol Cue Reactivity - N1 ERP component

    The reactivity to alcoholic cues will be assessed using the ACR task. The full task includes a total of 80 trials with 40 alcoholic and 40 non-alcoholic images obtained from the Amsterdam Beverage Picture Set. After EEG data collection, the mean amplitude of the N1 for alcoholic and non-alcoholic images of ACR task will be analyzed.

    1day after MI training

  • EEG correlates of Alcohol Cue Reactivity - P2 ERP component

    The reactivity to alcoholic cues will be assessed using the ACR task. The full task includes a total of 80 trials with 40 alcoholic and 40 non-alcoholic images obtained from the Amsterdam Beverage Picture Set. After EEG data collection, the mean amplitude of the P2 for alcoholic and non-alcoholic images of ACR task will be analyzed.

    Baseline (pre-training)

  • EEG correlates of Alcohol Cue Reactivity - P2 ERP component

    The reactivity to alcoholic cues will be assessed using the ACR task. The full task includes a total of 80 trials with 40 alcoholic and 40 non-alcoholic images obtained from the Amsterdam Beverage Picture Set. After EEG data collection, the mean amplitude of the P2 for alcoholic and non-alcoholic images of ACR task will be analyzed.

    1day after MI training

  • EEG correlates of Alcohol Cue Reactivity - Functional Connectivity

    The reactivity to alcoholic cues will be assessed using the ACR task. The full task includes a total of 80 trials with 40 alcoholic and 40 non-alcoholic images obtained from the Amsterdam Beverage Picture Set. After EEG data collection, FC patterns of visual and attentional networks will be assessed.

    Baseline (pre-training)

  • EEG correlates of Alcohol Cue Reactivity - Functional Connectivity

    The reactivity to alcoholic cues will be assessed using the ACR task. The full task includes a total of 80 trials with 40 alcoholic and 40 non-alcoholic images obtained from the Amsterdam Beverage Picture Set. After EEG data collection, the FC patterns of visual and attentional networks will be assessed.

    1day after MI training

  • Alcohol Consumption - Drinking pattern

    The Alcohol Use Disorder Identification Test (AUDIT; Babor, Higgins-Biddle, Saunders, Monteiro, 2001) will be administered to characterize the drinking pattern of the participants. AUDIT scores \< 8 reveal low risk of alcohol use; scores between 8 and 15 represent a risky consumption; scores from 16 to 19 are considered a harmful intake pattern; and scores ≥ 20 indicate very high risk for alcohol dependence and warrant further diagnostic evaluation for alcohol dependence.

    Screening Visit (Clinical Interview)

  • Alcohol Consumption - Drinking pattern

    The Alcohol Use Disorder Identification Test (AUDIT; Babor, Higgins-Biddle, Saunders, Monteiro, 2001) will be administered to characterize the drinking pattern of the participants. AUDIT scores \< 8 reveal low risk of alcohol use; scores between 8 and 15 represent a risky consumption; scores from 16 to 19 are considered a harmful intake pattern; and scores ≥ 20 indicate very high risk for alcohol dependence and warrant further diagnostic evaluation for alcohol dependence.

    At baseline (pre-training)

  • Alcohol Consumption - Drinking pattern

    The Alcohol Use Disorder Identification Test (AUDIT; Babor, Higgins-Biddle, Saunders, Monteiro, 2001) will be administered to characterize the drinking pattern of the participants. AUDIT scores \< 8 reveal low risk of alcohol use; scores between 8 and 15 represent a risky consumption; scores from 16 to 19 are considered a harmful intake pattern; and scores ≥ 20 indicate very high risk for alcohol dependence and warrant further diagnostic evaluation for alcohol dependence.

    10 days after MI training

  • Alcohol Consumption - Drinking pattern

    The Alcohol Use Disorder Identification Test (AUDIT; Babor, Higgins-Biddle, Saunders, Monteiro, 2001) will be administered to characterize the drinking pattern of the participants. AUDIT scores \< 8 reveal low risk of alcohol use; scores between 8 and 15 represent a risky consumption; scores from 16 to 19 are considered a harmful intake pattern; and scores ≥ 20 indicate very high risk for alcohol dependence and warrant further diagnostic evaluation for alcohol dependence.

    3 months after MI training

  • Alcohol consumption - Previous week

    The number of drinks in the previous week will be assessed using the Alcohol Timeline Followback (TLFB)

    At baseline (pre-training)

  • Alcohol consumption - Previous week

    The number of drinks in the previous week will be assessed using the Alcohol Timeline Followback (TLFB)

    10-days after MI training

  • Alcohol consumption - Previous week

    The number of drinks in the previous week will be assessed using the Alcohol Timeline Followback (TLFB)

    3-months after MI training

  • Alcohol consumption - Typical weeks

    The number of drinks during a standard/typical week and the frequency of typical weeks during the previous three months will be assessed using Typical and Atypical Drinking Diary (TADD).

    Baseline (pre-training)

  • Alcohol consumption - Typical weeks

    The number of drinks during a standard/typical week and the frequency of typical weeks during the previous three months will be assessed using Typical and Atypical Drinking Diary (TADD).

    3-months after MI training

  • Alcohol consumption - Atypical weeks

    the number of drinks during an atypical week (i.e., week with a greater consumption of alcohol) and the frequency of atypical weeks during the previous three months will be assessed using Typical and Atypical Drinking Diary (TADD).

    Baseline (pre-training)

  • Alcohol consumption - Atypical weeks

    the number of drinks during an atypical week (i.e., week with a greater consumption of alcohol) and the frequency of atypical weeks during the previous three months will be assessed using Typical and Atypical Drinking Diary (TADD).

    3-months after MI training

  • Alcohol Craving - Short-term acute craving

    Short-term alcohol craving levels will be assessed using the Alcohol Craving Questionnaire - Short form Revised (ACQ-SF-R) Portuguese version (Rodrigues et al., 2021). Total minimum score: 1 (low level of alcohol craving); Total maximum score: 7 (high level of alcohol craving)

    Baseline (pre-training)

  • Alcohol Craving - Short-term acute craving

    Short-term alcohol craving levels will be assessed using the Alcohol Craving Questionnaire - Short form Revised (ACQ-SF-R) Portuguese version (Rodrigues et al., 2021). Total minimum score: 1 (low level of alcohol craving); Total maximum score: 7 (high level of alcohol craving)

    10-days after MI training

  • Alcohol Craving - Short-term acute craving

    Short-term alcohol craving levels will be assessed using the Alcohol Craving Questionnaire - Short form Revised (ACQ-SF-R) Portuguese version (Rodrigues et al., 2021). Total minimum score: 1 (low level of alcohol craving); Total maximum score: 7 (high level of alcohol craving)

    3-months after MI training

  • Alcohol Craving - Past level of craving

    alcohol craving levels during the past week will be evaluated using Penn Alcohol Craving Scale (PACS) Portuguese version (Pombo, Ismail \& Cardoso, 2008). Total minimum score: 0 (low level of alcohol craving); Total maximum score: 36 (high level of alcohol craving)

    Baseline (pre-training)

  • Alcohol Craving - Past level of craving

    alcohol craving levels during the past week will be evaluated using Penn Alcohol Craving Scale (PACS) Portuguese version (Pombo, Ismail \& Cardoso, 2008). Total minimum score: 0 (low level of alcohol craving); Total maximum score: 36 (high level of alcohol craving)

    10-days after MI training

  • Alcohol Craving - Past level of craving

    alcohol craving levels during the past week will be evaluated using Penn Alcohol Craving Scale (PACS) Portuguese version (Pombo, Ismail \& Cardoso, 2008). Total minimum score: 0 (low level of alcohol craving); Total maximum score: 36 (high level of alcohol craving)

    3-months after MI training

Study Arms (4)

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

EXPERIMENTAL

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.

Device: Active tDCSBehavioral: Active CT

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

EXPERIMENTAL

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.

Device: Sham tDCSBehavioral: Active CT

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

SHAM COMPARATOR

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.

Device: Sham tDCSBehavioral: Sham CT

Non/Low-Drinkers

NO INTERVENTION

No intervention.

Interventions

Active tDCSDEVICE

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

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

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

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

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

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

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).

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

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Psychology

Braga, 4710-057, Portugal

Location

Related Publications (3)

  • 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.

    PMID: 30375668BACKGROUND

  • 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.

    PMID: 38871018DERIVED

  • 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.

    PMID: 35844233DERIVED

MeSH Terms

Conditions

Binge Drinking

Interventions

Exercise

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersAlcohol DrinkingDrinking BehaviorBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Eduardo G. López-Caneda, PhD

    University of Minho

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Researcher

Study Record Dates

First Submitted

January 17, 2022

First Posted

February 14, 2022

Study Start

February 5, 2019

Primary Completion

May 5, 2022

Study Completion

August 15, 2022

Last Updated

November 3, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)