Clinical trial NCT06840912: Electroencephalographic Biofeedback Therapy in Heroin Craving
Official title: Electroencephalographic Biofeedback Therapy in Heroin Craving
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electroencephalographic
Biofeedback Therapy
Heroin
Craving
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 40
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: we use EEG Biofeedback device for correction of abnormal wave amplitude in heroin addict patients after three months of abstinence aiming to decrease craving beside traditional pharmacotherapy
Primary purpose: TREATMENT

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

Detailed description: 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 .

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Brief substance craving scale( BSCS)
timeFrame: 14 months
Secondary outcomes:
measure: Electroencephalographic (EEG) biofeedback
timeFrame: 14 months
measure: General Health Questionnaire (GHQ-12)
timeFrame: 14 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References: