The goal of this randomized clinical trial is to verify if a Scott-Kaiser neurofeedback protocol can improve inhibitory control, reduce craving, and enhance treatment adherence in individuals with crack cocaine use disorder. The main research question is: does a 30-session, multi-phase neurofeedback intervention lead to better clinical outcomes, resulting in a more significant stabilization of the therapeutic pathway and reduction in relapse and drop-out rates, compared to treatment as usual (TAU) alone? Participants will: * Undergo initial assessment (T0) including psychological questionnaires, a computerized cognitive task, and quantitative EEG (qEEG) recording. * Be randomly assigned (1:1 ratio) to either receive 30 sessions of a modified Scott-Kaiser neurofeedback intervention (Experimental Group) or receive standard care alone (Control Group). * Complete the neurofeedback training (Experimental Group), which consists of 1 daily sessions of approximately 45 minutes divided into an initial Beta-SMR phase (5-10 sessions) and an advanced Alpha-Theta phase (20 sessions). * Undergo post-treatment assessment at approximately 30-45 days (T1) including psychological questionnaires, the cognitive task and qEEG. * A follow-up assessement 4-weeks after the end of the treatment including the same psychological questionnaires, cognitive task and qEEG (T2).
Chronic crack cocaine use represents one of the most severe forms of substance use disorder, characterized by rapid onset, high compulsivity, and elevated relapse rates. Chronic consumption is known to induce profound neurobiological alterations in fronto-striatal circuits and disrupt dopaminergic regulation, particularly within reward systems and mechanisms of inhibitory control. This interplay between neurophysiology, clinical psychopathology, and systemic biological responses highlights the necessity for multidimensional treatment models. While traditional psychosocial and pharmacological interventions show limited efficacy for this specific population, qEEG-guided neurofeedback has emerged as a promising non-invasive neuromodulation technique. By providing real-time feedback of neural activity, neurofeedback allows participants to learn brain autoregulation strategies, promoting neuroplasticity and enhancing cognitive and emotional control. This study focuses on a specific neurofeedback training program implementing the Scott-Kaiser modification of the Peniston Alpha-Theta protocol. This approach suggests that targeted training of distinct cortical rhythms can directly modulate clinical symptoms such as impulsivity and craving. While preliminary evidence supports the use of EEG biofeedback in addiction, there is a critical need for rigorous, randomized controlled designs to systematically evaluate the clinical efficacy of this protocol on both neurophysiological patterns and objective behavioral outcomes in crack cocaine users. Participants will be recruited from individuals hospitalized for crack cocaine use at the Short-Stay Accommodation Center (Centro di Pronta Accoglienza) of the ASP Palermo. It is planned to enroll a total sample of 104 participants (aged 18-55 years, stratified for sex and age). For initial assessment, interested subjects will be evaluated by using the Structured Clinical Interview for DSM-5 Disorders (SCID-5, incorporating the CV and PD modules), to operationalize psychiatric diagnoses and substance use profiles. Following the initial assessment and confirmation of eligibility, subjects will be randomized via an automated electronic system with allocation concealment to either the Experimental group or the Control group (1:1 ratio). All experimental and training sessions will occur in a controlled setting within the laboratory. * Neurophysiological parameters include qEEG spectral power analyses in the theta, alpha, SMR and beta bands, the beta/alpha and theta/beta ratios. * Behavioral and cognitive parameters include inhibitory control evaluated by a computerized Go/No-Go task, included in BFE-A battery. * Psychological assessment included: encompass current craving intensity (SCQ-NOW) and general psychopathology (GAD-7, PHQ-9). Upon arrival (T0 - Baseline, executed within 72 hours of admission across two dedicated days), initial psychometric and behavioral parameters will be collected. Resting-state qEEG parameters will be recorded using the DigiTrack 32-channel system to establish neurophysiological baselines. Subsequently, participants will enter their assigned parallel arms for the duration of the institutional stay. The Experimental group will receive standard institutional care (TAU) combined with 30 sessions of the modified Scott-Kaiser neurofeedback protocol, delivered via the DigiTrack system with interactive audiovisual feedback. This intervention is structured into two sequential phases at a rate of 1 daily sessions (45 minutes): Phase I consists of 5-10 sessions of Beta/SMR training to enhance cortical regulation and attentional control, followed by Phase II, consisting of 20 sessions of Alpha-Theta training focused on emotional regulation and craving reduction. The Control group will receive standard institutional TAU alone. The same assessment will be implemented at the end of the intervention protocol (T1) and at a 4 weeks follow-up (T2). This research aims to provide robust evidence on the efficacy of a multi-phase Scott-Kaiser neurofeedback protocol as a complementary tool for crack cocaine use disorder. Understanding these specific neurobiological and psychological shifts can inform the integration of non-invasive neuromodulation techniques within public health addiction services (SerD). By utilizing a randomized controlled design, the study aims to differentiate the specific neuroplastic and cognitive benefits of targeted EEG biofeedback from the general outcomes of standard clinical care. The findings may contribute to a broader scientific understanding of how targeted brain training influences autonomic cortical regulation and behavioral control, ultimately facilitating the adherence at the TAU, reducing craving and increasing inhibitory control, finally increasing the possibility to an occupational reintegration for recovering individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
104
The neurofeedback training protocol will consist of 25-30 sessions (1 daily sessions, lasting 45 minutes each), structured into an initial Phase I (5-10 sessions of Beta/SMR training) targeting attentional and inhibitory control, and a Phase II (20 sessions of Alpha-Theta training) focused on emotional regulation and craving reduction.
Centro di Pronta Accoglienza Dipendenze Patologiche
Palermo, Palermo, Italy
Behavioral Inhibitory Control and Cue Reactivity
Assessed with the computerized Modified Go/No-Go Task (MGNGT) from the Executive Functions Battery in Addiction (BFE-A), which incorporates both neutral and drug-related stimuli. The metrics evaluated include the number of commission errors, reflecting motor impulsivity and failure of inhibition, number of omission errors, and reaction times measured in milliseconds. Higher scores in commission errors indicate poorer inhibitory control.
Time frame: Baseline (T0, within 72 hours of admission), Post-Treatment (T1, approximately 30-45 days post-admission), and Follow-up (T2, 4 weeks post-discharge).
Neurophysiological Cortical Regulation (Resting-State qEEG Spectral Power)
Assessed via quantitative EEG (qEEG) data recorded through the DigiTrack 32-channel system at the Neuroscience and Behavioral Disorders Laboratory . Specific neurophysiological metrics include absolute and relative spectral power within the theta (4-8 Hz), alpha (8-12 Hz), beta (13-30 Hz) and sensorimotor rhythm (SMR, 12-15 Hz) frequency bands, alongside the calculation of the frontal theta/beta and alpha/theta ratios, which serve as neurofisiological markers of cortical arousal and vulnerability to craving.
Time frame: (T0, within 72 hours of admission), Post-Treatment (T1, approximately 40-45 days post-admission), and Follow-up (T2, 4 weeks post-discharge).
Treatment Adherence and Retention
Assessed with the institutional tracking of treatment dropout rates, defined as the proportion of participants who prematurely interrupt the treatment before clinical completion.
Time frame: Up to 4 weeks post-discharge (T2).
Clinical Relapse Rate
Assessed with the biological tests (saliva, urine or blood) of crack cocaine relapse events tracked during the treatment
Time frame: 4 weeks post-discharge (T2).
Crack Cocaine Craving Intensity
Assessed with the total score and subscale scores of the Substance Craving Questionnaire (SCQ-NOW). The total score ranges from 10 to 70, where higher scores reflect a greater subjective urge and current multidimensional craving for crack cocaine.
Time frame: Baseline (T0, within 72 hours of admission), Post-Treatment (T1, approximately 40-45 days post-admission), and Follow-up (T2, 4 weeks post-discharge).
Depression Symptoms Severity
Assessed with the total scores of Patient Health Questionnaire-9 (PHQ-9) scale (range 0-27). Higher scores indicate greater severity of current depressive symptomatology.
Time frame: Baseline (T0, within 72 hours of admission), Post-Treatment (T1, approximately 40-45 days post-admission), and Follow-up (T2, 4 weeks post-discharge).
Anxiety Symptoms Severity
Assessed with the total scores of the Generalized Anxiety Disorder-7 (GAD-7) scale (range 0-21). Higher scores indicate greater severity of current anxiety symptomatology.
Time frame: Baseline (T0, within 72 hours of admission), Post-Treatment (T1, approximately 40-45 days post-admission), and Follow-up (T2, 4 weeks post-discharge).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.