NEUROphysiology of CRACK Use Disorder in ITaly

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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).

Eligibility

Primary outcome measure(s)

• Behavioral Inhibitory Control and Cue Reactivity — Baseline (T0, within 72 hours of admission), Post-Treatment (T1, approximately 30-45 days post-admission), and Follow-up (T2, 4 weeks post-discharge).
  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.
• Neurophysiological Cortical Regulation (Resting-State qEEG Spectral Power) — (T0, within 72 hours of admission), Post-Treatment (T1, approximately 40-45 days post-admission), and Follow-up (T2, 4 weeks post-discharge).
  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.

Trial sites (1)