Google Maps

NCT07735923

Overview

NCT ID: NCT07735923
Lead Sponsor: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone PalermoOTHER
Official Title: Efficacy of a Neurofeedback Protocol for Crack Cocaine Users in Residential Treatment: A Randomized Clinical Trial
Brief 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).

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 30, 2026Actual
Start Date: Sep 1, 2026Estimated
Primary Completion Date: Apr 1, 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 104Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: Giuseppe Maniaci, PhDContact
giuseppe.maniaci02@unipa.it+393294354408

Similar Studies

Participant Group/Arms

Neurofeedback (NF)Experimental

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)

Device: EEG-Biofeedback - Scott-Kaiser Protocol

Treatment as Usual (TAU)No Intervention

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