Clinical trial NCT05910749: Substance Use Disorder, Brain and Behavioral Regulation
Official title: Brain and Behavioral Regulation Processes in a Population With Substance Use Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Substance Use Disorders
Lead sponsor: University of Puerto Rico
Sponsor class: OTHER
First posted: 2023-06-20
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre-experimental repeated measured design
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion criteria

* 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)

Exclusion criteria

* History of brain injury.
* Previous experience with neurofeedback training.
* Being unavailable to complete assessments.

Primary outcomes:
measure: sLORETA Brodmann Areas Voxels Z-Scores
timeFrame: 2 months
measure: Event-Related Potentials P300 latencies
timeFrame: 2 months
measure: Event-Related Potentials P300 amplitudes Drug-cue Go
timeFrame: 2 months
Secondary outcomes:
measure: Attentional Executive Functioning NIH Toolbox Task
timeFrame: 2 months
measure: Episodic Memory NIH Toolbox Task
timeFrame: 2 months
measure: Working Memory NIH Toolbox Task
timeFrame: 2 months
measure: Executive Function NIH Toolbox Task
timeFrame: 2 months
measure: Processing Speed NIH Toolbox Task
timeFrame: 2 months
measure: Drug-cue Go Task Reaction Times
timeFrame: 2 months
measure: Drug-cue Go Task Omission Errors
timeFrame: 2 months
measure: Drug-cue NoGo Task Commission Errors
timeFrame: 2 months
Other outcomes:
Locations:
city: San Juan
country: Puerto Rico
facility: Administración de Servicios de Salud Mental y Contra la Adicción. Centro Residencial de Mujeres y Varones
Study officials:
affiliation: University of Puerto Rico
name: Ismael Castillo Reyes, PhD
role: PRINCIPAL_INVESTIGATOR
References: