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

Summary

Background: Alcohol Use Disorder (AUD) is a complex psychiatric disorder, involving several brain areas and neurocircuits. Transcranial Direct Current Stimulation (tDCS) allows to stimulate superficial areas of brain using a weak electrical current. Preliminary data suggest that tDCS may reduce alcohol craving and consumption.

Objectives: The main outcome is to test if tDCS can reduce alcohol craving and use and to assess the changes in BDNF and pro-BDNF levels. Secondary outcomes are the assessment of other psychiatric dimensions (mood, behavioral and cognitive alterations) associated with prolonged alcohol use.

Eligibility: Healthy, right-handed adults ages 18-65 who do have AUD (moderate to severe).

Design: This is a randomized, double-blind, sham-controlled study with three phases: 1) a tDCS intensive treatment phase; 2) follow-up with weekly tDCS stimulation; 3) follow-up without tDCS stimulation.

Participants will be screened with:

* Psychometric Scales
* Medical history
* Physical exam
* Urine tests and breathalyzer
* After being enrolled, baseline behavioral and laboratory data will be collected. In particular, participants will undergo:
* Psychometric Scales
* Venous blood sample (BDNF/proBDNF levels)

Participants will be randomized to real or sham tDCS arm. The stimulation will be delivered daily for five days during the first week (intensive treatment phase) and then weekly for 3 months (follow-up with stimulation). During this period patient will be tested with a behavioral and psychometric evaluation.Therefore, participants will receive 3 follow-up monthly visits without tDCS stimulation, in which behavioral and psychometric data will be collected.

Treatment includes:

* tDCS: The tDCS will be delivered with a stimulator connected to two sponge electrodes, soaked in a saline solution. The stimulation will be administered at a current intensity of approximately 1 mA, for the duration of 20 minutes. The anode will be placed on the right DLPFC, the cathode on the contralateral cortical area.
* BDNF/proBDNF levels: A venous blood sample will be collected before the first stimulation and after the last stimulation of the intensive-stimulation period (first week). The blood sample will be centrifuged within 20 minutes of sampling at 1000 × g for 15 minutes. Then, the serum will be aliquoted and stored at -80 ° C until analysis.
* Repeat of screening tests and questionnaires
* Urine toxicological screen and breathalyzer

Conditions

• Alcohol Use Disorder (AUD)
• Alcohol Abuse
• Alcohol Dependence
• Alcohol-Related Disorders
• Drug Abuse
• Substance Use Disorders
• Mental Disorder

Interventions

DEVICE

Active transcranial Direct Current Stimulation

tDCS is a non-invasive brain stimulation technique. The investigators will use a BrainSTIM (EMS, Bologna, Italy)

DEVICE

Sham transcranial Direct Current Stimulation

tDCS is a non-invasive brain stimulation technique. The investigators will use a BrainSTIM (EMS, Bologna, Italy)

Sponsors & Collaborators

• ITAB - Institute for Advanced Biomedical Technologies

  lead OTHER

Principal Investigators

• Massimo di Giannantonio, MD · ITAB - Institute for Advanced Biomedical Technologies

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-01

Primary Completion

2026-07-31

Completion

2026-11-30