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临床试验/NCT06840912
NCT06840912已完成不适用

Electroencephalographic Biofeedback Therapy in Heroin Craving

Tanta University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年2月1日最近更新:
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Brief substance craving scale( BSCS)

研究概览

简要总结

The aim of this work is to assess the effectiveness of electroencephalography (EEG) biofeedback in management of heroin craving .

详细描述

Substance use disorder is characterized by physiological dependence accompanied by the withdrawal syndrome upon abstinence from the drug, psychological dependence, tolerance, expressed in the escalation of the dose needed to achieve a desired euphoric state , and craving which is a pathological motivational state that leads to active drug-seeking behavior which leads to relapse . substance use disorder is a chronic, relapsing mental disease that results from the prolonged effects of drugs on the brain.

Narcotic drugs addiction is recurrent and chronic mental illness with severe motivational disorders and loss of behavioral control.

Craving is a penchant and persistent desire of drugs consumption, if it is not met, will have Psychological and physical sufferings, such as fatigue, anorexia, anxiety, insomnia, aggression, and depression. Also, voracity is very strong sense and urgent desiring to one thing, so that any possibility of focusing on something other than the asked subject is impossible. EEG biofeedback is an operant conditioning technique used to reinforce certain waves and inhibit others, in heroin patients, there is a decrease in mean alpha wave and SMR wave amplitude which persist and excess beta wave activity which abolished after 3 months of abstinence , increase in mean SMR wave amplitude lead to decrease impulsivity and improve attention , increase in alpha wave mean amplitude , decrease anxiety which accompany craving .

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
None

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • All persons included in this study are males.
  • Persons aged from 20 to 50 years.
  • Addicts abusing one substance only (heroin).
  • They had received at least 3 months of pharmacological treatment.
  • complete blood and urine test had been taken from all participants.
  • Subjects must be able to comprehend and perform study related information and tasks , are willing to complete study procedures.

排除标准

  • Addicts abusing other substances with heroin.
  • History of any neurological disorder that would result in abnormal electroencephalography (EEG) activity such as seizure disorders, stroke.
  • Currently on a medication which is known to alter electroencephalography (EEG) activity as anticonvulsant, anticholinergic or benzodiazepine.
  • Age younger than 20 and older than 50 years.
  • Patients suffering from any psychiatric disorders in addition to heroin abuse.

研究组 & 干预措施

EEG biofeedback beside pharmacotherapy group

Experimental

Patients with heroin use disorder diagnosed according to DSM-5 criteria (Diagnostic and Statistical Manual of Mental Disorders 5th edition), treated by pharmacological ( symptomatic treatment only ) in addition to electroencephalographic (EEG) biofeedback device after 3 months of abstinence.

干预措施: Pharmacological in addition to electroencephalographic (EEG) biofeedback (Other)

pharmacotherapy group

Other

Patients with heroin use disorder taken as control group matching with patients group in terms of age, gender, daily heroin use and duration of use , treated only by pharmacotherapy ( symptomatic treatment only).

干预措施: Pharmacotherapy (Drug)

结局指标

主要结局

Brief substance craving scale( BSCS)

时间窗: 14 months

Brief substance craving scale ( BSCS): It is a self-report instrument to assess craving for heroin abuse over a 24 hour period. Patients were asked to complete a scale, rating the intensity, frequency and length of their cravings. Ratings were then scored on a scale of 0 to 12 (0) meaning no cravings- (12) meaning the patient was experiencing severe craving. 1. The intensity of my craving, that is, how much I desired this drug in the past 24 hours was: a- None at all. b- Slight. c-Moderate. d- Considerable. e- Extreme 2. The frequency of my craving, that is, how often I desired this drug in the past 24 hours was: a- Never b- Almost never. c-Several times. d- Regular. Performed at baseline to both groups before starting EEG Biofeedback . At the next day after completion of twenty sessions of EEG Biofeedback. After 1 month follow up. After 2 month follow up. There was a decrease in brief substance craving scale in experimental group in comparison to control group.

次要结局

  • Electroencephalographic (EEG) biofeedback(14 months)
  • General Health Questionnaire (GHQ-12)(14 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alaa El sayed Ali Elhout

Resident of Neuropsychiatry, Faculty of Medicine, Tanta University, Tanta, Egypt.

Tanta University

研究点 (1)

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