Clinical Trial

NEUROphysiology of CRACK Use Disorder in ITaly

Study acronym: NEURO-CRACK-IT
Not Yet Recruiting
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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).
Trial Details
NCT Number NCT07735923
Lead Sponsor Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Collaborators: Centro di Pronta Accoglienza Dipendenze Patologiche Palermo
Conditions Crack Cocaine Use
Enrollment 104 participants
Start Date 2026-09-01
Primary Completion 2028-04-01 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-30