NCT01876524

Brief Summary

The purpose of this study is to study the efficacy and security of noninvasive brain stimulation as a new approach for patients with Substance Use Disorders (SUDs) plus other psychiatric conditions like ADHD, Schizophrenia, Bipolar disorder, etc.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2013

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

First Submitted

Initial submission to the registry

June 10, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2013

Completed
19 days until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

1.1 years

First QC Date

June 10, 2013

Last Update Submit

January 31, 2026

Conditions

Attention Deficit Disorder With HyperactivityBipolar DisorderSchizophreniaPersonality DisorderSubstance Use Disorder

Keywords

Substance Use DisorderAttention Deficit Disorder With HyperactivitySchizophreniaBipolar disorderPersonality disorder

Outcome Measures

Primary Outcomes (2)

  • AMEN Questionnarie

    100 Items Questionnarie subdivided in 5 subscales: basal ganglia, cingulate cortez, temporal cortex, prefrontal cortex and limbic system

    Following patients during 3 months after Brain noninvasive estimulation

  • Emotional Visual Event Related Potentials

    Emotional Visual Event Related Potentials responses (time courses and topographies) and ICA components related with them, identified by Mitsar 201M EEG Amplifier using EEGLab software \[ Time Frame: brainwaves patterns following an array of visual stimuli (human faces) during a 22 min. examination \]

    Following patients during 3 months after Brain noninvasive estimulation

Secondary Outcomes (1)

  • CAGE Adapted to Include Drugs (CAGE-AID)

    Following 3 months after tRNS brain stimulation

Study Arms (3)

tRNS over Anterior Cingulate

EXPERIMENTAL

Dual Pathology (Substance Use Disorder plus another psychiatric trait) 75 patients with diagnosed SUDs plus another psychiatric disorder will be receive tRNS in the disease-specific Anterior Cingulate Cortex (ACC), be studied blindly to evaluate the craving reduction after 35 tRNS sessions.

Device: Transcranial Random Noise Stimulation

tRNS applied over DLPFC

EXPERIMENTAL

Dual Pathology (Substance Use Disorder plus another psychiatric trait) 75 patients with diagnosed SUDs plus another psychiatric disorder will be receive tRNS in the dorso-lateral-prefrontal-cortex (DLPFC), be studied blindly to evaluate the craving reduction after 35 tRNS sessions.

Device: Transcranial Random Noise Stimulation

Sham Group

SHAM COMPARATOR

75 patients will be receive tRNS sham 35 sessions.

Device: Transcranial Random Noise Stimulation

Interventions

Transcranial Random Noise StimulationDEVICE

Random Noise Stimulation between 100 and 500 Hz and 400-500 microAmperes are applied over head in particular areas

Also known as: tRNS, tES
Sham GrouptRNS applied over DLPFCtRNS over Anterior Cingulate

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \> 18 years old and less than 60 years
  • Best-practice diagnosed Dual Pathology
  • Diagnosed since at least two years prior to enrollment.
  • Abuse more than 2 Substances
  • Serious visual and hearing loss
  • Brain injury following cranial trauma
  • Other neurological disorders like Parkinson, ME, headache, etc.
  • Birth trauma
  • Mental retardation
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Slow Environment Foundation

Cartagena, Murcia, 30310, Spain

Location

Related Publications (6)

  • Manni C, Cipollone G, Pallucchini A, Maremmani AGI, Perugi G, Maremmani I. Remarkable Reduction of Cocaine Use in Dual Disorder (Adult Attention Deficit Hyperactive Disorder/Cocaine Use Disorder) Patients Treated with Medications for ADHD. Int J Environ Res Public Health. 2019 Oct 15;16(20):3911. doi: 10.3390/ijerph16203911.

    PMID: 31618876BACKGROUND

  • Allenby C, Falcone M, Bernardo L, Wileyto EP, Rostain A, Ramsay JR, Lerman C, Loughead J. Transcranial direct current brain stimulation decreases impulsivity in ADHD. Brain Stimul. 2018 Sep-Oct;11(5):974-981. doi: 10.1016/j.brs.2018.04.016. Epub 2018 Apr 23.

    PMID: 29885858BACKGROUND

  • Cubillo A, Halari R, Smith A, Taylor E, Rubia K. A review of fronto-striatal and fronto-cortical brain abnormalities in children and adults with Attention Deficit Hyperactivity Disorder (ADHD) and new evidence for dysfunction in adults with ADHD during motivation and attention. Cortex. 2012 Feb;48(2):194-215. doi: 10.1016/j.cortex.2011.04.007. Epub 2011 Apr 27.

    PMID: 21575934BACKGROUND

  • Fonteneau C, Redoute J, Haesebaert F, Le Bars D, Costes N, Suaud-Chagny MF, Brunelin J. Frontal Transcranial Direct Current Stimulation Induces Dopamine Release in the Ventral Striatum in Human. Cereb Cortex. 2018 Jul 1;28(7):2636-2646. doi: 10.1093/cercor/bhy093.

    PMID: 29688276BACKGROUND

  • Westwood SJ, Criaud M, Lam SL, Lukito S, Wallace-Hanlon S, Kowalczyk OS, Kostara A, Mathew J, Agbedjro D, Wexler BE, Cohen Kadosh R, Asherson P, Rubia K. Transcranial direct current stimulation (tDCS) combined with cognitive training in adolescent boys with ADHD: a double-blind, randomised, sham-controlled trial. Psychol Med. 2023 Jan;53(2):497-512. doi: 10.1017/S0033291721001859. Epub 2021 Jul 6.

    PMID: 34225830RESULT

  • Antal A, Alekseichuk I, Bikson M, Brockmoller J, Brunoni AR, Chen R, Cohen LG, Dowthwaite G, Ellrich J, Floel A, Fregni F, George MS, Hamilton R, Haueisen J, Herrmann CS, Hummel FC, Lefaucheur JP, Liebetanz D, Loo CK, McCaig CD, Miniussi C, Miranda PC, Moliadze V, Nitsche MA, Nowak R, Padberg F, Pascual-Leone A, Poppendieck W, Priori A, Rossi S, Rossini PM, Rothwell J, Rueger MA, Ruffini G, Schellhorn K, Siebner HR, Ugawa Y, Wexler A, Ziemann U, Hallett M, Paulus W. Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Clin Neurophysiol. 2017 Sep;128(9):1774-1809. doi: 10.1016/j.clinph.2017.06.001. Epub 2017 Jun 19.

    PMID: 28709880RESULT

Related Links

MeSH Terms

Conditions

Substance-Related DisordersAttention Deficit Disorder with HyperactivityBipolar DisorderSchizophreniaPersonality Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersBipolar and Related DisordersMood DisordersSchizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2013

First Posted

June 12, 2013

Study Start

July 1, 2013

Primary Completion

August 1, 2014

Study Completion

September 1, 2014

Last Updated

February 3, 2026

Record last verified: 2026-01

Locations

ES(1)