Binge DrinkingNCT05237414
Combining Cognitive Training With tDCS to Enhance Memory Inhibition in Young Binge Drinkers
A study testing Active tDCS and Active CT in people with Binge Drinking, run by University of Minho at 1 site in Portugal.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Binge Drinking
- What is being tested?
- Active tDCS and Active CT
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 sitePortugal
- Study dates
- 5 Feb 2019to 15 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Forgetting Alcohol: a Double-blind, Randomized Controlled Trial Investigating Memory Inhibition Training in Young Binge Drinkers.
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.
Read the detailed 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.
- Conditions
- Binge Drinking
- Being tested
- Active tDCS, Sham tDCS, Active CT, Sham CT
- Keywords
- Alcohol, Craving, Binge Drinking, College Students, Memory Inhibition, Alcohol-Related Memories, Randomized Controlled Trial, Intervention Protocol, Cognitive Training, Transcranial Direct-Current Stimulation (tDCS), Electroencephalography (EEG), Event-Related Potentials (ERPs), Functional Connectivity
- Medical subject headings
- Binge Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCSDevice
20 minutes of 2.0 mA direct current applied over the right DLPFC
Sham tDCSDevice
15 seconds of 2.0 mA direct current applied over the right DLPFC
Active CTBehavioural
Active memory inhibition CT (i.e., training of memory inhibition specifically for alcohol-related memories).
Sham CTBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Active tDCS; Behavioral: 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. Receives: Device: Sham tDCS; Behavioral: 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. Receives: Device: Sham tDCS; Behavioral: Sham CT |
| Non/Low-Drinkers | No intervention | No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 3-months after MI training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start5 Feb 2019
- Primary completion5 May 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Binge DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eduardo López-Caneda, University of Minho
- Investigators
- Eduardo G. López-Caneda, PhD, Principal investigator, University of Minho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237414
- Sponsor's protocol ID
- PTDC/PSI-ESP/28672/2017
- Other IDs
- CE.CSH 078/2018, PTDC/PSI-ESP/28672/2017
- Status last verified
- Nov 2022
- First submitted
- 17 Jan 2022
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30375668Almeida-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.
PubMed 38871018Almeida-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.
PubMed 35844233
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Forgetting Alcohol: a Double-blind, Randomized Controlled Trial Investigating Memory Inhibition Training in Young Binge Drinkers.
- ClinicalTrials.gov ID
- NCT05237414
- Acronym / sponsor ID
- PTDC/PSI-ESP/28672/2017
- Conditions
- Binge Drinking
- Keywords
- Alcohol, Craving, Binge Drinking, College Students, Memory Inhibition, Alcohol-Related Memories, Randomized Controlled Trial, Intervention Protocol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- University of MinhoUniversity, hospital or other
- Study start
- 5 Feb 2019 (actual)
- Primary completion
- 5 May 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Binge Drinkers with Combined Intervention (active CT + active tDCS) | Experimental | Device: Active tDCS, Behavioral: Active CTSubjects 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. |
| Binge Drinkers with Cognitive Intervention (active CT + sham tDCS) | Experimental | Device: Sham tDCS, Behavioral: Active CTSubjects 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. |
| Binge Drinkers with Control Intervention (sham CT + sham tDCS) | Sham comparator | Device: Sham tDCS, Behavioral: Sham CTSubjects 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. |
| Non/Low-Drinkers | No intervention | –No intervention. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active tDCS20 minutes of 2.0 mA direct current applied over the right DLPFC | Device | Binge Drinkers with Combined Intervention (active CT + active tDCS) |
| Sham tDCS15 seconds of 2.0 mA direct current applied over the right DLPFC | Device | Binge Drinkers with Cognitive Intervention (active CT + sham tDCS), Binge Drinkers with Control Intervention (sham CT + sham tDCS) |
| Active CTActive memory inhibition CT (i.e., training of memory inhibition specifically for alcohol-related memories). | Behavioural | Binge Drinkers with Cognitive Intervention (active CT + sham tDCS), Binge Drinkers with Combined Intervention (active CT + active tDCS) |
| Sham CTSham 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). | Behavioural | Binge Drinkers with Control Intervention (sham CT + sham tDCS) |
Primary outcome
Behavioral Memory Inhibition Performance
Time frame: At baseline (pre-training)
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.
Behavioral Memory Inhibition Performance
Time frame: 1day after MI training
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.
EEG correlates of Memory Inhibition Performance - N2 ERP component
Time frame: At baseline (pre-training)
After EEG data collection, the mean amplitude of N2 component will be analyzed.
EEG correlates of Memory Inhibition Performance - N2 ERP component
Time frame: 1day after MI training
After EEG data collection, the mean amplitude of N2 component will be analyzed.
EEG correlates of Memory Inhibition Performance - LPP ERP component
Time frame: At baseline (pre-training)
After EEG data collection, the mean amplitude of Late Parietal Positivity (LPP) will be analyzed.
EEG correlates of Memory Inhibition Performance - LPP ERP component
Time frame: 1day after MI training
After EEG data collection, the mean amplitude of Late Parietal Positivity (LPP) will be analyzed.
EEG correlates of Memory Inhibition Performance - Frontal slow wave (FSW) ERP component
Time frame: At baseline (pre-training)
After EEG data collection, the mean amplitudes of FSW will be analyzed
EEG correlates of Memory Inhibition Performance - Frontal slow wave (FSW) ERP component
Time frame: 1day after MI training
After EEG data collection, the mean amplitudes of FSW will be analyzed
EEG correlates of Memory Inhibition Performance - Functional connectivity (FC)
Time frame: At baseline (pre-training)
FC patterns within/between regions associated with MI (e.g., DLPFC and hippocampal/parahippocampal regions) will also be assessed.
EEG correlates of Memory Inhibition Performance - Functional connectivity (FC)
Time frame: 1day after MI training
FC patterns within/between regions associated with MI (e.g., DLPFC and hippocampal/parahippocampal regions) will also be assessed.
Alcohol Cue Reactivity - Emotional measures
Time frame: At baseline (pre-training)
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.
Alcohol Cue Reactivity - Emotional measures
Time frame: 1day after MI training
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.
EEG correlates of Alcohol Cue Reactivity - P1 ERP component
Time frame: At baseline (pre-training)
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.
EEG correlates of Alcohol Cue Reactivity - P1 ERP component
Time frame: 1day after MI training
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.
EEG correlates of Alcohol Cue Reactivity - N1 ERP component
Time frame: Baseline (pre-training)
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.
EEG correlates of Alcohol Cue Reactivity - N1 ERP component
Time frame: 1day after MI training
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.
EEG correlates of Alcohol Cue Reactivity - P2 ERP component
Time frame: Baseline (pre-training)
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.
EEG correlates of Alcohol Cue Reactivity - P2 ERP component
Time frame: 1day after MI training
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.
EEG correlates of Alcohol Cue Reactivity - Functional Connectivity
Time frame: Baseline (pre-training)
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.
EEG correlates of Alcohol Cue Reactivity - Functional Connectivity
Time frame: 1day after MI training
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.
Alcohol Consumption - Drinking pattern
Time frame: Screening Visit (Clinical Interview)
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.
Alcohol Consumption - Drinking pattern
Time frame: At baseline (pre-training)
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.
Alcohol Consumption - Drinking pattern
Time frame: 10 days after MI training
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.
Alcohol Consumption - Drinking pattern
Time frame: 3 months after MI training
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.
Alcohol consumption - Previous week
Time frame: At baseline (pre-training)
The number of drinks in the previous week will be assessed using the Alcohol Timeline Followback (TLFB)
Alcohol consumption - Previous week
Time frame: 10-days after MI training
The number of drinks in the previous week will be assessed using the Alcohol Timeline Followback (TLFB)
Alcohol consumption - Previous week
Time frame: 3-months after MI training
The number of drinks in the previous week will be assessed using the Alcohol Timeline Followback (TLFB)
Alcohol consumption - Typical weeks
Time frame: Baseline (pre-training)
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).
Alcohol consumption - Typical weeks
Time frame: 3-months after MI training
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).
Alcohol consumption - Atypical weeks
Time frame: Baseline (pre-training)
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).
Alcohol consumption - Atypical weeks
Time frame: 3-months after MI training
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).
Alcohol Craving - Short-term acute craving
Time frame: Baseline (pre-training)
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)
Alcohol Craving - Short-term acute craving
Time frame: 10-days after MI training
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)
Alcohol Craving - Short-term acute craving
Time frame: 3-months after MI training
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)
Alcohol Craving - Past level of craving
Time frame: Baseline (pre-training)
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)
Alcohol Craving - Past level of craving
Time frame: 10-days after MI training
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)
Alcohol Craving - Past level of craving
Time frame: 3-months after MI training
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Background: PubMed 30375668Lopez-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.
- Derived from this study: PubMed 38871018Almeida-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.
- Derived from this study: PubMed 35844233Almeida-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo G. López-Caneda, PhD principal investigator
University of Minho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tDCS and Active CT in people with Binge Drinking, run by University of Minho at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral Memory Inhibition Performance (time frame: At baseline (pre-training)). The study lists 37 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05237414, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.