NEUROphysiology of CRACK Use Disorder in ITaly
Starting soon · Not applicable
Conditions studied: Crack Cocaine Use
In brief
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).
Key facts
- Study ID
- NCT07735923
- Run by
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
- People needed
- 104
- Starts
- 2026-09-01
- Expected to finish
- 2029-12-31
- Last updated by the study team
- 2026-07-30
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Centro di Pronta Accoglienza Dipendenze Patologiche — Palermo, Palermo, Italy
Full record on ClinicalTrials.gov
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