NEUROphysiology of CRACK Use Disorder in ITaly (NEURO-CRACK-IT)
Efficacy of a Neurofeedback Protocol for Crack Cocaine Users in Residential Treatment: A Randomized Clinical Trial
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).
調査の概要
詳細な説明
Chronic crack cocaine use represents one of the most severe forms of substance use disorder, characterized by rapid onset, high compulsivity, and elevated relapse rates. Chronic consumption is known to induce profound neurobiological alterations in fronto-striatal circuits and disrupt dopaminergic regulation, particularly within reward systems and mechanisms of inhibitory control. This interplay between neurophysiology, clinical psychopathology, and systemic biological responses highlights the necessity for multidimensional treatment models. While traditional psychosocial and pharmacological interventions show limited efficacy for this specific population, qEEG-guided neurofeedback has emerged as a promising non-invasive neuromodulation technique. By providing real-time feedback of neural activity, neurofeedback allows participants to learn brain autoregulation strategies, promoting neuroplasticity and enhancing cognitive and emotional control. This study focuses on a specific neurofeedback training program implementing the Scott-Kaiser modification of the Peniston Alpha-Theta protocol. This approach suggests that targeted training of distinct cortical rhythms can directly modulate clinical symptoms such as impulsivity and craving. While preliminary evidence supports the use of EEG biofeedback in addiction, there is a critical need for rigorous, randomized controlled designs to systematically evaluate the clinical efficacy of this protocol on both neurophysiological patterns and objective behavioral outcomes in crack cocaine users.
Participants will be recruited from individuals hospitalized for crack cocaine use at the Short-Stay Accommodation Center (Centro di Pronta Accoglienza) of the ASP Palermo. It is planned to enroll a total sample of 104 participants (aged 18-55 years, stratified for sex and age). For initial assessment, interested subjects will be evaluated by using the Structured Clinical Interview for DSM-5 Disorders (SCID-5, incorporating the CV and PD modules), to operationalize psychiatric diagnoses and substance use profiles. Following the initial assessment and confirmation of eligibility, subjects will be randomized via an automated electronic system with allocation concealment to either the Experimental group or the Control group (1:1 ratio).
All experimental and training sessions will occur in a controlled setting within the laboratory.
- Neurophysiological parameters include qEEG spectral power analyses in the theta, alpha, SMR and beta bands, the beta/alpha and theta/beta ratios.
- Behavioral and cognitive parameters include inhibitory control evaluated by a computerized Go/No-Go task, included in BFE-A battery.
- Psychological assessment included: encompass current craving intensity (SCQ-NOW) and general psychopathology (GAD-7, PHQ-9).
Upon arrival (T0 - Baseline, executed within 72 hours of admission across two dedicated days), initial psychometric and behavioral parameters will be collected. Resting-state qEEG parameters will be recorded using the DigiTrack 32-channel system to establish neurophysiological baselines. Subsequently, participants will enter their assigned parallel arms for the duration of the institutional stay.
The Experimental group will receive standard institutional care (TAU) combined with 30 sessions of the modified Scott-Kaiser neurofeedback protocol, delivered via the DigiTrack system with interactive audiovisual feedback. This intervention is structured into two sequential phases at a rate of 1 daily sessions (45 minutes): Phase I consists of 5-10 sessions of Beta/SMR training to enhance cortical regulation and attentional control, followed by Phase II, consisting of 20 sessions of Alpha-Theta training focused on emotional regulation and craving reduction. The Control group will receive standard institutional TAU alone. The same assessment will be implemented at the end of the intervention protocol (T1) and at a 4 weeks follow-up (T2).
This research aims to provide robust evidence on the efficacy of a multi-phase Scott-Kaiser neurofeedback protocol as a complementary tool for crack cocaine use disorder. Understanding these specific neurobiological and psychological shifts can inform the integration of non-invasive neuromodulation techniques within public health addiction services (SerD). By utilizing a randomized controlled design, the study aims to differentiate the specific neuroplastic and cognitive benefits of targeted EEG biofeedback from the general outcomes of standard clinical care. The findings may contribute to a broader scientific understanding of how targeted brain training influences autonomic cortical regulation and behavioral control, ultimately facilitating the adherence at the TAU, reducing craving and increasing inhibitory control, finally increasing the possibility to an occupational reintegration for recovering individuals.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Giuseppe Maniaci, PhD
- 電話番号：+393294354408
- メール：giuseppe.maniaci02@unipa.it
研究場所
-
-
Palermo
-
Palermo、Palermo、イタリア、90100
- Centro di Pronta Accoglienza Dipendenze Patologiche
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Neurofeedback (NF)
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)
|
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.
|
|
介入なし：Treatment as Usual (TAU)
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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Behavioral Inhibitory Control and Cue Reactivity
時間枠：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.
|
Baseline (T0, within 72 hours of admission), Post-Treatment (T1, approximately 30-45 days post-admission), and Follow-up (T2, 4 weeks post-discharge).
|
|
Neurophysiological Cortical Regulation (Resting-State qEEG Spectral Power)
時間枠：(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.
|
(T0, within 72 hours of admission), Post-Treatment (T1, approximately 40-45 days post-admission), and Follow-up (T2, 4 weeks post-discharge).
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Treatment Adherence and Retention
時間枠：Up to 4 weeks post-discharge (T2).
|
Assessed with the institutional tracking of treatment dropout rates, defined as the proportion of participants who prematurely interrupt the treatment before clinical completion.
|
Up to 4 weeks post-discharge (T2).
|
|
Clinical Relapse Rate
時間枠：4 weeks post-discharge (T2).
|
Assessed with the biological tests (saliva, urine or blood) of crack cocaine relapse events tracked during the treatment
|
4 weeks post-discharge (T2).
|
|
Crack Cocaine Craving Intensity
時間枠：Baseline (T0, within 72 hours of admission), Post-Treatment (T1, approximately 40-45 days post-admission), and Follow-up (T2, 4 weeks post-discharge).
|
Assessed with the total score and subscale scores of the Substance Craving Questionnaire (SCQ-NOW).
The total score ranges from 10 to 70, where higher scores reflect a greater subjective urge and current multidimensional craving for crack cocaine.
|
Baseline (T0, within 72 hours of admission), Post-Treatment (T1, approximately 40-45 days post-admission), and Follow-up (T2, 4 weeks post-discharge).
|
|
Depression Symptoms Severity
時間枠：Baseline (T0, within 72 hours of admission), Post-Treatment (T1, approximately 40-45 days post-admission), and Follow-up (T2, 4 weeks post-discharge).
|
Assessed with the total scores of Patient Health Questionnaire-9 (PHQ-9) scale (range 0-27).
Higher scores indicate greater severity of current depressive symptomatology.
|
Baseline (T0, within 72 hours of admission), Post-Treatment (T1, approximately 40-45 days post-admission), and Follow-up (T2, 4 weeks post-discharge).
|
|
Anxiety Symptoms Severity
時間枠：Baseline (T0, within 72 hours of admission), Post-Treatment (T1, approximately 40-45 days post-admission), and Follow-up (T2, 4 weeks post-discharge).
|
Assessed with the total scores of the Generalized Anxiety Disorder-7 (GAD-7) scale (range 0-21).
Higher scores indicate greater severity of current anxiety symptomatology.
|
Baseline (T0, within 72 hours of admission), Post-Treatment (T1, approximately 40-45 days post-admission), and Follow-up (T2, 4 weeks post-discharge).
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 27/2025
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。