Electroencephalographic Biofeedback Therapy in Heroin Craving

February 18, 2025 updated by: Alaa El sayed Ali Elhout, Tanta University
The aim of this work is to assess the effectiveness of electroencephalography (EEG) biofeedback in management of heroin craving .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • El-Gharbia
      • Tanta, El-Gharbia, Egypt, 31527
        • Tanta university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EEG biofeedback beside pharmacotherapy group
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
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.
Other: pharmacotherapy group
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
Patients with heroin use disorder taken as control group matching with patients group treated only by pharmacotherapy
Other Names:
  • Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief substance craving scale( BSCS)
Time Frame: 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.
14 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electroencephalographic (EEG) biofeedback
Time Frame: 14 months

Assessment of mean brain waves amplitude by EEG biofeedback device "Thought technology Ltd Flex Comp Infinti" ( used as treatment and assessment device ) , only assessment methods for both group, and treatment method to experimental group.

we use two protocols in experimental group : ten sessions of SMR /Theta protocol and another ten of alpha / Theta protocol every other day for 50 minutes we asses mean SMR wave amplitude to both groups at base line , then after completion of sessions , one and two months after.

we assess also mean Alpha wave amplitude to both groups at base line , then after completion of sessions , one and two months after.

there was an increase in both SMR and Alpha wave mean amplitude in experimental group in comparison to control group, this means decrease impulsivity and increase attention (SMR wave amplitude increase ), decrease anxiety by increase in mean alpha wave amplitude .
14 months
General Health Questionnaire (GHQ-12)
Time Frame: 14 months

The 12-Item General Health Questionnaire (GHQ-12) consists of 12 items, each one assessing the severity of a mental problem over the past few weeks using a 4-point Likert-type scale (from 0 to 3). The score was used to generate a total score ranging from 0 to 36. The positive items were corrected from 0 (always) to 3 (never) and the negative ones from 3 (always) to 0 (never). High scores indicate worse health. It includes three factors, namely Anxiety and Depression, Social Dysfunction, and Loss of Confidence.

  1. Score from (0-15): normal without distress.
  2. Score from (16-25): mild distress.

  3. Score more than or equal 25: severe distress.

    • It was preformed at baseline before starting EEG Biofeedback.
    • At the next day after completion of twenty sessions of EEG Biofeedback to experimental group I , and assessment of control group at the same time.
    • After 1 month follow up.
    • After 2 month follow up. it decreased in experimental group in comparison to control group.
14 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Actual)

May 1, 2024

Study Completion (Actual)

May 1, 2024

Study Registration Dates

First Submitted

February 12, 2025

First Submitted That Met QC Criteria

February 18, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 18, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 36264MS20/1/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD Sharing Time Frame

After the end of study for one year.

IPD Sharing Access Criteria

The data will be available upon a reasonable request from the corresponding author

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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