Substance Use DisordertRND&SUDsNCT01876524
tRNS in Anterior Cingulate Cortex Reduces Craving Over Dual Pathology Patients
A study testing Transcranial Random Noise Stimulation in people with Substance Use Disorder and Attention Deficit Disorder With Hyperactivity, run by Spanish Foundation for Neurometrics Development at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Substance Use Disorder, Attention Deficit Disorder With Hyperactivity, Bipolar Disorder
- What is being tested?
- Transcranial Random Noise Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2013to Sep 2014
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- > 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
- ExclusionC riteria:
- Serious visual and hearing loss
Show all 11Show fewer
- Brain injury following cranial trauma
- Other neurological disorders like Parkinson, ME, headache, etc.
- Birth trauma
- Mental retardation
- Pregnant
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcranial Random Noise Stimulation in Anterior Cingulate Cortex Reduces Craving Over Dual Pathology Patients
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.
Read the detailed description
Background: There is an intimate relationship between addictive behaviors and other mental disorders, proven by clinical practice and many epidemiological studies, genetic and neuroscience. This gives risk to the diagnosis of Dual Pathology: an addiction and another mental disorder.
Functional neuroimaging studies have shown that anterior cingulate cortex is associated with substance´s dependence and craving. Transcranial random noise stimulation (tRNS) stimulates parts of the brain and can change it´s activity.
Researchers are interested in reduce cravings for substance dependence on patients with Dual Pathology using tRNS in anterior cingulate cortex.
Aims: To determine whether tRNS in anterior cingulate cortex can reduce craving over Dual Pathology patients.
- Conditions
- Substance Use Disorder, Attention Deficit Disorder With Hyperactivity, Bipolar Disorder, Schizophrenia, Personality Disorder
- Being tested
- Transcranial Random Noise Stimulation
- Keywords
- Substance Use Disorder, Attention Deficit Disorder With Hyperactivity, Schizophrenia, Bipolar disorder, Personality disorder
- Medical subject headings
- Substance-Related Disorders, Attention Deficit Disorder with Hyperactivity, Bipolar Disorder, Schizophrenia, Personality Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Random Noise StimulationDevice
Also called tRNS, tES
Random Noise Stimulation between 100 and 500 Hz and 400-500 microAmperes are applied over head in particular areas
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Transcranial Random Noise Stimulation |
| Sham Group | Sham comparator | 75 patients will be receive tRNS sham 35 sessions. Receives: Device: Transcranial Random Noise Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
AMEN Questionnarie
100 Items Questionnarie subdivided in 5 subscales: basal ganglia, cingulate cortez, temporal cortex, prefrontal cortex and limbic system
Measured: 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 ]
Measured: Following patients during 3 months after Brain noninvasive estimulation
Secondary outcomes (1)
CAGE Adapted to Include Drugs (CAGE-AID)
The CAGE-AID is a sensitive screen for alcohol and drug problems.
Measured: Following 3 months after tRNS brain stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionAug 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Foundation for Neurometrics Development
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Citlalli Mellado Balanzar, Spanish Foundation for Neurometrics Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01876524
- Sponsor's protocol ID
- tRNS01072013
- Acronym
- tRND&SUDs
- Status last verified
- Sep 2026
- First submitted
- 10 Jun 2013
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31618876Allenby 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.
PubMed 29885858Cubillo 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.
PubMed 21575934Fonteneau 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.
PubMed 29688276Westwood 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.
PubMed 34225830Antal 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.
PubMed 28709880
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Random Noise Stimulation in Anterior Cingulate Cortex Reduces Craving Over Dual Pathology Patients
- ClinicalTrials.gov ID
- NCT01876524
- Acronym / sponsor ID
- tRND&SUDs / tRNS01072013
- Conditions
- Substance Use Disorder, Attention Deficit Disorder With Hyperactivity, Bipolar Disorder, Schizophrenia, Personality Disorder
- Keywords
- Substance Use Disorder, Attention Deficit Disorder With Hyperactivity, Schizophrenia, Bipolar disorder, Personality disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Spanish Foundation for Neurometrics DevelopmentUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 12 Jun 2013 (estimated)
- 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.
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.
Detailed description
Background: There is an intimate relationship between addictive behaviors and other mental disorders, proven by clinical practice and many epidemiological studies, genetic and neuroscience. This gives risk to the diagnosis of Dual Pathology: an addiction and another mental disorder.
Functional neuroimaging studies have shown that anterior cingulate cortex is associated with substance´s dependence and craving. Transcranial random noise stimulation (tRNS) stimulates parts of the brain and can change it´s activity.
Researchers are interested in reduce cravings for substance dependence on patients with Dual Pathology using tRNS in anterior cingulate cortex.
Aims: To determine whether tRNS in anterior cingulate cortex can reduce craving over Dual Pathology patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tRNS over Anterior Cingulate | Experimental | Device: Transcranial Random Noise StimulationDual 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. |
| tRNS applied over DLPFC | Experimental | Device: Transcranial Random Noise StimulationDual 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. |
| Sham Group | Sham comparator | Device: Transcranial Random Noise Stimulation75 patients will be receive tRNS sham 35 sessions. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- > 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
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Transcranial Random Noise StimulationAlso: tRNS, tESRandom Noise Stimulation between 100 and 500 Hz and 400-500 microAmperes are applied over head in particular areas | Device | Sham Group, tRNS applied over DLPFC, tRNS over Anterior Cingulate |
Primary outcome
AMEN Questionnarie
Time frame: Following patients during 3 months after Brain noninvasive estimulation
100 Items Questionnarie subdivided in 5 subscales: basal ganglia, cingulate cortez, temporal cortex, prefrontal cortex and limbic system
Emotional Visual Event Related Potentials
Time frame: Following patients during 3 months after Brain noninvasive estimulation
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 ]
1 secondary outcome
CAGE Adapted to Include Drugs (CAGE-AID)
Time frame: Following 3 months after tRNS brain stimulation
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 10 Sep 2026.
- Background: PubMed 31618876Manni 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.
- Background: PubMed 29885858Allenby 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.
- Background: PubMed 21575934Cubillo 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.
- Background: PubMed 29688276Fonteneau 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.
- Results publication: PubMed 34225830Westwood 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.
- Results publication: PubMed 28709880Antal 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.
- Bigdata4brain LLCLink provided by the sponsor.
- Brainmech FoundationLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Random Noise Stimulation in people with Substance Use Disorder and Attention Deficit Disorder With Hyperactivity, run by Spanish Foundation for Neurometrics Development at 1 site in Spain.
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 11 inclusion and 0 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 10 Sep 2026. 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 Spain. 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?
AMEN Questionnarie (time frame: Following patients during 3 months after Brain noninvasive estimulation). The study lists 2 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 NCT01876524, which also lists 6 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 10 Sep 2026.