NEUROphysiology of CRACK Use Disorder in ITaly (NEURO-CRACK-IT)

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

Status: Not yet enrolling

Conditions: Crack Cocaine Use

Treatments: Device: EEG-Biofeedback - Scott-Kaiser Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT07735923

27/2025

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women aging between 18 and 55;
• Able to understand the study protocols and provide written informed consent;
• Currently admitted or hospitalized at the Short-Stay Accommodation Center (Centro di Pronta Accoglienza) of ASP Palermo (Pisani site) for crack cocaine use.

Exclusion criteria

• Presence of neurological conditions, including traumatic brain injury with neurological sequelae, uncontrolled epilepsy, previous stroke with significant residual cognitive or motor deficits, or active encephalitis.
• Severe unstable medical conditions that contraindicate the application of electroencephalography (EEG) or venous blood sampling.
• Current pregnancy.
• Inability to fully comprehend the study information or express a valid, autonomous written informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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104 participants in 2 patient groups

Neurofeedback (NF)

Experimental group

Description:

Participants will be seated in a controlled laboratory setting. This neuromodulation technique, rooted in quantitative EEG (qEEG)-guided conditioning which actively utilizes real-time neurophysiological feedback, involves multi-channel skull electrode placement and advanced software processing. It is specifically aimed at promoting cortical regulation and facilitating cognitive-emotional stabilization across distinct training phases throughout the clinical protocol, enhancing targeted neural oscillatory patterns. Selected interactive audiovisual scenarios accompany the session. The intervention will be delivered alongside standard institutional care (TAU)

Treatment:

Device: EEG-Biofeedback - Scott-Kaiser Protocol

Treatment as Usual (TAU)

No Intervention group

Description:

This group is designed to provide the clinical comparative baseline of standard care. Participants will receive standard multi-disciplinary institutional care provided by the clinical facility, while undergoing identical diagnostic, psychometric, and laboratory timelines used in the experimental group. This care is deliberately non-specific to neurophysiological brain-training and contrasts with the targeted quantitative EEG-guided operant conditioning provided to the experimental group. Participants in this group will not receive neurofeedback training sessions. The TAU protocol will span the same duration of the treatment in the Experimental group