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NEUROphysiology of CRACK Use Disorder in ITaly
Sponsor: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Summary
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).
Official title: Efficacy of a Neurofeedback Protocol for Crack Cocaine Users in Residential Treatment: A Randomized Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
104
Start Date
2026-09-01
Completion Date
2029-12-31
Last Updated
2026-07-30
Healthy Volunteers
No
Conditions
Interventions
EEG-Biofeedback - Scott-Kaiser Protocol
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.
Locations (1)
Centro di Pronta Accoglienza Dipendenze Patologiche
Palermo, Palermo, Italy