Electroencephalographic Biofeedback Therapy in Heroin Craving

NCT06840912 | Completed

• 1 other identifier: 36264MS20/1/23
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Electroencephalographic; Biofeedback Therapy; Heroin; Craving

Outcome Measures

Primary Outcomes (1)

• Brief substance craving scale( BSCS)

  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.

  14 months

Secondary Outcomes (2)

• Electroencephalographic (EEG) biofeedback

  14 months

• General Health Questionnaire (GHQ-12)

  14 months

Study Arms (2)

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.

Other: Pharmacological in addition to electroencephalographic (EEG) biofeedback

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).

Drug: Pharmacotherapy

Interventions

Pharmacological in addition to electroencephalographic (EEG) biofeedback OTHER

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

EEG biofeedback beside pharmacotherapy group

Pharmacotherapy DRUG

Patients with heroin use disorder taken as control group matching with patients group treated only by pharmacotherapy

Also known as: Control group

pharmacotherapy group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Gender Eligibility Details: All persons included in this study are males.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Interventions

Biofeedback, Psychology; Drug Therapy; Control Groups

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Neuropsychiatry, Faculty of Medicine, Tanta University, Tanta, Egypt.

Model Details: 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

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 21, 2025
• Study Start: February 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)