Transcranial Direct Current Stimulation on Inhibitory Control in Addictions.

NCT05350033 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-04-27

No results posted yet for this study

Summary

The research in neuroscience of the last 20 years is defined, in addition to continuing to advance in the field of behavioral and pharmacological therapy, by the birth and development of a new therapeutic category, called neuromodulation. Neuromodulation offers the possibility of producing changes in the Nervous System (SN) and therefore, in behavior, in addition to lasting over time. One of the most used non-invasive neuromodulation techniques is transcranial direct current stimulation (tDCS). The benefits of tDCS are promising and varied, so it is a potential neurorehabilitation tool, which has also shown its greatest effectiveness when accompanied by complementary rehabilitation treatment. The present study focuses on the effect of tDCS on addiction. Specifically, there is a great problem with the high rates of relapse presented by those individuals who try to abandon addictive behavior. Therefore, the maintenance of the abstinence period is the central theme of addiction research and the main challenge of rehabilitation at present. For that aim, the intervention will be carried out in a sample in the intermediate phase (internal) in the NOESSO (No EstáS Sólo) therapeutic community (Almería, Spain), between day 15 after arrival and the first day to leave on leave (day 45-60). The research will be made up of a previous period of selection and collection of data related to addiction, together with two phases or moments of correlative intervention and evaluation. Users will receive a bilateral (F3/F4) and repeated stimulation of 2 mA intensity for 20 min each, that is, every 24h for 5 consecutive days in each phase. Through this procedure, the aim is to seek to increase adherence to treatment in the early intervention phase and decrease the dropout rate due to the enhancement of inhibitory control. On the other hand, in the second phase, advanced intervention is sought to reduce craving, through an improvement in inhibitory and emotional control at the time of returning to the context of real consumption. In order to increase the knowledge about intra-individual differences in the effect of tDCS, researchers will compare the early intervention (Phase 1, at the begging of the rehabilitation process) with the advanced intervention (Phase 2, right before the first leave).

Conditions

  • Substance-Related Disorders

Interventions

DEVICE

tDCS - tDCS

active-tDCS administered during 10 sessions, in Phase 1 and Phase 2

DEVICE

tDCS - Sham

active-tDCS administered during 5 sessions, in Phase 1

DEVICE

Sham - tDCS

active-tDCS administered during 5 sessions, in Phase 2

DEVICE

Sham - Sham

sham-tDCS administered during 10 sessions, in Phase 1 and Phase 2

Sponsors & Collaborators

  • Junta de Andalucia

    collaborator OTHER_GOV
  • Universidad de Almeria

    lead OTHER

Principal Investigators

  • Fernando Sánchez-Santed, PhD · Universidad de Almeria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-05
Primary Completion
2022-07-15
Completion
2022-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05350033 on ClinicalTrials.gov