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NEUROphysiology of CRACK Use Disorder in ITaly

NCT07735923 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2026-07-30

No results posted yet for this 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).

Conditions

  • Crack Cocaine Use

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Centro di Pronta Accoglienza Dipendenze Patologiche Palermo

    collaborator UNKNOWN

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-04-01
Completion
2029-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07735923 on ClinicalTrials.gov