Substance Use DisordersNCT05910749
Substance Use Disorder, Brain and Behavioral Regulation
A study testing QEEG-Guided sLoreta Neurofeedback Training in people with Substance Use Disorders, run by University of Puerto Rico at 1 site in Puerto Rico.
Trial summary
The proposed project seeks to explore the effects of a neuroregulation paradigm named Z-Score Quantitative Electroencephalogram (QEEG) guided sLORETA neurofeedback (ZQLN) on optimizing brain electrophysiological activity and behavioral performance in a substance use disorder (SUD) population whose primary drug of use… Read more about this study
- Who is it for?
- Ages 21 to 51 years
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- QEEG-Guided sLoreta Neurofeedback Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 sitePuerto Rico
- Study dates
- 1 Apr 2025to 30 May 2026
- 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 21 to 51 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age limit: 21 to 51
- Cocaine as a primary drug of selection
- Be stable (such as not having reading or movement problems preventing them from using a computer keyboard or iPad).
- Have completed the first stage of treatment in the program (this first phase consists of the stabilization and detoxification period of the program participants)
Who cannot join
- History of brain injury.
- Previous experience with neurofeedback training.
- Being unavailable to complete assessments.
Trial locations and contacts
1 site in 1 country.
Puerto Rico1 site
Administración de Servicios de Salud Mental y Contra la Adicción. Centro Residencial de Mujeres y Varones
San Juan, PR, 00935
About this study
Official title: Brain and Behavioral Regulation Processes in a Population With Substance Use Disorder
The proposed project seeks to explore the effects of a neuroregulation paradigm named Z-Score Quantitative Electroencephalogram (QEEG) guided sLORETA neurofeedback (ZQLN) on optimizing brain electrophysiological activity and behavioral performance in a substance use disorder (SUD) population whose primary drug of use is cocaine.
Read the detailed description
Aim 1. Measure the effects of ZQLN training on brain electrophysiological activation changes in SUD patients. QEEG and Event-Related Potentials procedures, recorded with a 19-channel digital EEG, will be conducted before and after 12-15 sessions of ZQLN to examine changes on dysregulated brain sites by inspection of the brain maps deviating brain areas sLORETA Brodmann Areas Voxels Z-Scores inside and outside the target window of -/+2 standard deviations. Observation of P300 component latencies and amplitudes will be measured during a Drug-cue GoNoGo paradigm.
Aim 2. Measure the effects of ZQLN training on behavioral performance changes in SUD patients. In the same participants of Aim 1, Pre and Post behavioral performance (before and after 12-15 sessions of ZQLN) includes the assessment of attention and executive function, episodic memory, working memory language, and processing speed as measured by the NIH Toolbox Cognitive Domains battery scales. Other behavioral variables include reaction times, omission, and commission errors in the Drug-cue GoNoGo task.
- Conditions
- Substance Use Disorders
- Being tested
- QEEG-Guided sLoreta Neurofeedback Training
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QEEG-Guided sLoreta Neurofeedback TrainingDevice
The team will produce a neurofeedback (NFB) protocol based on QEEG sLORETA Brodmann Voxel evaluation of brain deviated/dysregulated areas. Subsequent 12 to15 sessions of individualized NFB protocol will be conducted using BrainAvatar software to normalize these regions. The NFB session will display the cortical surface and subsurface networks being trained in a live fashion. Patients will be seated on a comfortable chair in a dimly lit room and, wearing a 19-channel EEG-cap connected to an EEG amplifier, they will receive auditory and visual feedback when they meet Brodmann Voxels Z-Scores inside of +/-1.5 standard deviations (SD) on each electrode training site. Thresholds for the feedback will be first set a +/-2 SD and brought down to +/-1.5 SD throughout the sessions (subject performance dependent). Patients are encouraged to relax, hear the sounds, and watch a feedback game.
| Study group | Role | What they receive |
|---|---|---|
| QEEG-guided sLoreta Neurofeedback | Experimental | Brainmaster Discovery 24 EEG amplifier and BrainAvatar software will be used to conduct the neurofeedback sessions Receives: Device: QEEG-Guided sLoreta Neurofeedback Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
sLORETA Brodmann Areas Voxels Z-Scores
An increase of the percent of sLORETA Brodmann Areas Voxels Z-Scores inside the target window of -/+2 standard deviations after a series of ZQLN sessions is expected.
Measured: 2 months
Event-Related Potentials P300 latencies
Brain response P300 component average latencies (measured in milliseconds) Drug-cue GoNoGo task.
Measured: 2 months
Event-Related Potentials P300 amplitudes Drug-cue Go
Brain response P300 component average amplitudes (measured in microvolts) during Drug-cue GoNoGo. task.
Measured: 2 months
Secondary outcomes (8)
Attentional Executive Functioning NIH Toolbox Task
Flanker Inhibitory Control and Attention Task. The allocation of one's limited capacities to deal with abundance of environmental stimulation (duration 3 minutes)
Measured: 2 months
Episodic Memory NIH Toolbox Task
Picture Sequence Memory Task. Cognitive processes involved in the acquisition, storage and retrieval of new information. (7 minutes duration)
Measured: 2 months
Working Memory NIH Toolbox Task
List Sorting Working Memory Task. The ability to store information until the amount of information to be stored exceeds one's capacity to hold that information. (7 minutes duration)
Measured: 2 months
Executive Function NIH Toolbox Task
Dimensional Change Card Sort Task. The capacity to plan, organize, and monitor the executive of behaviors that are strategically directed in a goal-oriented manner. (4 minutes duration)
Measured: 2 months
Processing Speed NIH Toolbox Task
Pattern Comparison Processing Speed Test. Assesses the amount of information that can be processed within a certain unit of time. Items are simple so as to purely measure processing speed. (3 minute duration)
Measured: 2 months
Drug-cue Go Task Reaction Times
Average Reaction times (measured in milliseconds) to the Go stimulus. In the first block of the task the Go stimulus will be a neutral category (animal or household) and in the second block the Go stimulus will be the drug-related picture.
Measured: 2 months
Drug-cue Go Task Omission Errors
Average frequency of omission errors (not responding to the Go stimulus). In the first block of the task the Go stimulus will be a neutral category (animal or household) and in the second block the Go stimulus will be the drug-related picture.
Measured: 2 months
Drug-cue NoGo Task Commission Errors
Average frequency of commission errors (responding to the NoGo stimulus). In the first block of the task the Go stimulus will be a neutral category (animal or household) and in the second block the Go stimulus will be the drug-related picture.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2023
- Study start1 Apr 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion30 May 2026 (estimated)
Why it stopped: The study was not carried out because it was not approved by NIH.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-experimental repeated measured design
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Puerto Rico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ismael Castillo Reyes, PhD, Principal investigator, University of Puerto Rico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910749
- Sponsor's protocol ID
- PuertoRico
- Status last verified
- Oct 2025
- First submitted
- 27 Mar 2023
- Last updated
- 10 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data and findings will be published in peer-review health sciences journals and presented at national and international scientific conferences, especially those related to Neurotherapy, cognitive neuroscience, and biological psychiatry. Findings and insights gained from this study will be shared with government agencies, and medical institutions that provide services for neuro and psychiatric patients, both in Puerto Rico and in the U.S. General Data, without personal identifiers, will be made available to other researchers in Puerto Rico and other institutions outside the country for secondary analyses in their areas of expertise, or confirmation of the adequacy of our findings and conclusions. The research resources developed during the proposed project will be readily available for research purposes to qualified individuals within the scientific community to advance further research in this field. Findings will also be shared via newspapers, news releases, and press conferences.
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain and Behavioral Regulation Processes in a Population With Substance Use Disorder
- ClinicalTrials.gov ID
- NCT05910749
- Acronym / sponsor ID
- PuertoRico
- Conditions
- Substance Use Disorders
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was not carried out because it was not approved by NIH.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Puerto RicoUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 20 Jun 2023 (actual)
- 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 proposed project seeks to explore the effects of a neuroregulation paradigm named Z-Score Quantitative Electroencephalogram (QEEG) guided sLORETA neurofeedback (ZQLN) on optimizing brain electrophysiological activity and behavioral performance in a substance use disorder (SUD) population whose primary drug of use is cocaine.
Detailed description
Aim 1. Measure the effects of ZQLN training on brain electrophysiological activation changes in SUD patients. QEEG and Event-Related Potentials procedures, recorded with a 19-channel digital EEG, will be conducted before and after 12-15 sessions of ZQLN to examine changes on dysregulated brain sites by inspection of the brain maps deviating brain areas sLORETA Brodmann Areas Voxels Z-Scores inside and outside the target window of -/+2 standard deviations. Observation of P300 component latencies and amplitudes will be measured during a Drug-cue GoNoGo paradigm.
Aim 2. Measure the effects of ZQLN training on behavioral performance changes in SUD patients. In the same participants of Aim 1, Pre and Post behavioral performance (before and after 12-15 sessions of ZQLN) includes the assessment of attention and executive function, episodic memory, working memory language, and processing speed as measured by the NIH Toolbox Cognitive Domains battery scales. Other behavioral variables include reaction times, omission, and commission errors in the Drug-cue GoNoGo task.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-experimental repeated measured design
| Arm | Type | Receives |
|---|---|---|
| QEEG-guided sLoreta Neurofeedback | Experimental | Device: QEEG-Guided sLoreta Neurofeedback TrainingBrainmaster Discovery 24 EEG amplifier and BrainAvatar software will be used to conduct the neurofeedback sessions |
Who may qualify
- Ages
- 21 to 51 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age limit: 21 to 51
- Cocaine as a primary drug of selection
- Be stable (such as not having reading or movement problems preventing them from using a computer keyboard or iPad).
- Have completed the first stage of treatment in the program (this first phase consists of the stabilization and detoxification period of the program participants)
Key exclusion criteria (3 listed)
- History of brain injury.
- Previous experience with neurofeedback training.
- Being unavailable to complete assessments.
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 |
|---|---|---|
| QEEG-Guided sLoreta Neurofeedback TrainingThe team will produce a neurofeedback (NFB) protocol based on QEEG sLORETA Brodmann Voxel evaluation of brain deviated/dysregulated areas. Subsequent 12 to15 sessions of individualized NFB protocol will be conducted using BrainAvatar software to normalize these regions. The NFB session will display the cortical surface and subsurface networks being trained in a live fashion. Patients will be seated on a comfortable chair in a dimly lit room and, wearing a 19-channel EEG-cap connected to an EEG amplifier, they will receive auditory and visual feedback when they meet Brodmann Voxels Z-Scores inside of +/-1.5 standard deviations (SD) on each electrode training site. Thresholds for the feedback will be first set a +/-2 SD and brought down to +/-1.5 SD throughout the sessions (subject performance dependent). Patients are encouraged to relax, hear the sounds, and watch a feedback game. | Device | QEEG-guided sLoreta Neurofeedback |
Primary outcome
sLORETA Brodmann Areas Voxels Z-Scores
Time frame: 2 months
An increase of the percent of sLORETA Brodmann Areas Voxels Z-Scores inside the target window of -/+2 standard deviations after a series of ZQLN sessions is expected.
Event-Related Potentials P300 latencies
Time frame: 2 months
Brain response P300 component average latencies (measured in milliseconds) Drug-cue GoNoGo task.
Event-Related Potentials P300 amplitudes Drug-cue Go
Time frame: 2 months
Brain response P300 component average amplitudes (measured in microvolts) during Drug-cue GoNoGo. task.
8 secondary outcomes
Attentional Executive Functioning NIH Toolbox Task
Time frame: 2 months
Episodic Memory NIH Toolbox Task
Time frame: 2 months
Working Memory NIH Toolbox Task
Time frame: 2 months
Executive Function NIH Toolbox Task
Time frame: 2 months
Processing Speed NIH Toolbox Task
Time frame: 2 months
Drug-cue Go Task Reaction Times
Time frame: 2 months
Drug-cue Go Task Omission Errors
Time frame: 2 months
Drug-cue NoGo Task Commission Errors
Time frame: 2 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2025.
- Individual participant dataSharing planned: Yes. Data and findings will be published in peer-review health sciences journals and presented at national and international scientific conferences, especially those related to Neurotherapy, cognitive neuroscience, and biological psychiatry. Findings and insights gained from this study will be shared with government agencies, and medical institutions that provide services for neuro and psychiatric patients, both in Puerto Rico and in the U.S. General Data, without personal identifiers, will be made available to other researchers in Puerto Rico and other institutions outside the country for secondary analyses in their areas of expertise, or confirmation of the adequacy of our findings and conclusions. The research resources developed during the proposed project will be readily available for research purposes to qualified individuals within the scientific community to advance further research in this field. Findings will also be shared via newspapers, news releases, and press conferences.
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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.
Ismael Castillo Reyes, PhD principal investigator
University of Puerto Rico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QEEG-Guided sLoreta Neurofeedback Training in people with Substance Use Disorders, run by University of Puerto Rico at 1 site in Puerto Rico.
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 4 inclusion and 3 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: withdrawn, as of the sponsor's last update on 10 Oct 2025. 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 Puerto Rico. 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
sLORETA Brodmann Areas Voxels Z-Scores (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2025.