Efficacy of a Neurofeedback Protocol for Crack Cocaine Users in Residential Treatment: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Behavioral Inhibitory Control and Cue Reactivity
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Behavioral Inhibitory Control and Cue Reactivity
时间窗: 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)
时间窗: (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.
次要结局
- Treatment Adherence and Retention(Up to 4 weeks post-discharge (T2).)
- Clinical Relapse Rate(4 weeks post-discharge (T2).)
- Crack Cocaine Craving Intensity(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(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(Baseline (T0, within 72 hours of admission), Post-Treatment (T1, approximately 40-45 days post-admission), and Follow-up (T2, 4 weeks post-discharge).)
研究者
Giuseppe Maniaci
Assistant Professor
University of Palermo