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Trial · NCT04897295

Neurobiological Effects of Transcranial Direct Current Stimulation Treatment in Alcohol Use Disorder

NCT04897295, Not applicable, Not yet recruiting, ITAB - Institute for Advanced Biomedical Technologies

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Neurobiological Effects of Transcranial Direct Current Stimulation Treatment in Alcohol Use Disorder. Trials, record NCT04897295. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04897295

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Neurobiological Effects of Transcranial Direct Current Stimulation Treatment in Alcohol Use Disorder
NCT number
NCT04897295
Status
Not yet recruiting
Phases
Not applicable
Enrollment
30 participants, estimated
Lead sponsor
ITAB - Institute for Advanced Biomedical Technologies
Conditions
Alcohol Use Disorder (AUD), Alcohol Abuse, Alcohol Dependence, Alcohol-Related Disorders, Drug Abuse, Substance Use Disorders, Mental Disorder
Interventions
Active transcranial Direct Current Stimulation, Sham transcranial Direct Current Stimulation
First posted
2021-05-21
Last updated
2021-10-26

Source ClinicalTrials.gov

Registered outcomes25

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in BDNF levelBaseline and after tDCS treatment: one week
BDNF levels will be evaluated by collecting a venous blood sample. BDNF is a member of the nerve growth factor (NGF) family of neurotrophic growth factors. Low levels of peripheral BDNF and NGF have been reported in mood disorders and other psychopathological conditions with normalization after antidepressant treatment or mood stabilization. The increase in serum levels of BDNF seems to reflect the concomitant activation of BDNF synthesis that accompanies the neuronal remodeling triggered by the suspension of alcohol intake and suggests that the synthesis of BDNF may have a role in the long-term maintenance of alcohol abstention. BDNF measurements will be calculated in pg/ml
PrimaryChange in pro-BDNFBaseline and after tDCS treatment: one week
Pro-BDNF is the precursor of BDNF and it acts as a repository of mature BDNF and acts itself by inducing neuronal thinning. Pro-BDNF levels will be evaluated by collecting a venous blood sample. Pro-BDNF measurements will be calculated in ng/ml.
PrimaryChange in pro-BDNF/BDNF ratio.Baseline and after tDCS treatment: one week
Pro-BDNF/BDNF ratio, seems to be a more specific measurement of the early changes in the metabolism of BDNF. Its level seems to correlate to more or less a neurotrophic and neuroprotective action of BDNF.
PrimaryChange in alcohol consumption as assessed by Alcohol Timeline Follow Back (TLFB-Alcohol)Baseline, after tDCS treatment: one week, two weeks, 6 weeks, 3 months, 6 months
The TLFB is a calendar-based interview method in which the individual retrospectively identifies the days when alcohol was assumed, and the number of standard drinks consumed on those days. // Alcohol consumption will be assessed using the TimeLine Follow Back (TLFB). TLFB is an interview-based assessment. Using a calendar, participants are guided through the process of recalling and reporting daily alcohol consumption. TLFB provides measures of alcohol consumption per week, alcohol consuming days per week, heavy alcohol consuming days per week.
PrimaryChange in alcohol craving as assessed by the Visual Analog Scale for Craving (VAS 0-10 Craving)Baseline, after tDCS treatment: one week, two weeks, 6 weeks, 3 months, 6 monthsAlcohol craving intensity will be assessed using a visual analog scale (VAS). Participants sign subjective feelings of craving on a 10 cm line marked from zero (null) to 10 (the most intense).
PrimaryChange in alcohol craving characteristics as assessed by the Brief Substance Craving Scale (BSCS)Baseline, after tDCS treatment: one week, two weeks, 6 weeks, 3 months, 6 monthsAlcohol craving will be assessed using the Brief Substance Craving Scale (BSCS). The BSCS is a 16 item, self-report instrument assesses craving for substances of abuse over a 24 hour period.
PrimaryAbsence of alcohol intoxication evaluated by breathalyzerBaseline, before the stimulation each day of treatment, each meeting of follow-up
Alcohol consumption will be evaluated by breathalyzer. Breathalyzer measures breath alcohol concentration (BrAC) levels; the BrAC-data was interpreted as blood alcohol content (BAC). Semi-quantitative analyses are performed. The breathalyzer can differentiate five levels: negative (0 - 0.07 gr / L), low (0.07 - 0.3 gr / L), warn (0.31 - 0.5 gr / L), fall (0.51 - 0.8 gr / L), fall + (\> 0.8 gr / L)
PrimaryEvaluation of craving subtype assessed by the Craving Typology Questionnaire (CTQ)Baseline
Alcohol craving subtype will be assessed using the Craving Typology Questionnaire (CTQ). It is a self-report questionnaire measuring three supposedly independent typologies of alcohol craving: relief, obsessive and reward craving.
SecondaryChanges in Montgomery-Asberg Depression Scale (MADRS) Total ScoreBaseline, after tDCS treatment: one week, two weeks, 6 weeks, 3 months, 6 months
The MADRS is a 10-item scale that evaluates the core symptoms and cognitive features of clinical depression. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms.
SecondaryChange in substances consumption as assessed by Urine Drug Screen (UDS)Baseline, after tDCS treatment: one week and randomly at follow-up meetings
Substances consumption will be evaluated by Urine Drug Screen (UDS). Urine Drug Screen is a test to evaluate the presence of substances of abuse in urine samples. Quantitative analyses are not performed. Test may be positive or negative for the presence of substances of abuse.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests3

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

TestNamed asSource
Go/No-Go TaskSecondary outcomeConductCognition
Iowa Gambling LiteSecondary outcomeConductCognition
Stroop Color-Word TestSecondary outcomeConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04897295

GET https://conductscience.org/api/trials/v1/NCT04897295/registered?page=2