ElectroencephalographicNCT06840912
Electroencephalographic Biofeedback Therapy in Heroin Craving
A study testing Pharmacological in addition to electroencephalographic (EEG) biofeedback and Pharmacotherapy in people with Electroencephalographic and Biofeedback Therapy, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this work is to assess the effectiveness of electroencephalography (EEG) biofeedback in management of heroin craving . Read more about this study
- Who is it for?
- Ages 20 to 50 years, men only
- Conditions the study is for
- Electroencephalographic, Biofeedback Therapy, Heroin
- What is being tested?
- Pharmacological in addition to electroencephalographic (EEG) biofeedback and Pharmacotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this work is to assess the effectiveness of electroencephalography (EEG) biofeedback in management of heroin craving .
Read the 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 .
- Conditions
- Electroencephalographic, Biofeedback Therapy, Heroin, Craving
- Being tested
- Pharmacological in addition to electroencephalographic (EEG) biofeedback, Pharmacotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacological in addition to electroencephalographic (EEG) biofeedbackOther
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.
PharmacotherapyDrug
Also called Control group
Patients with heroin use disorder taken as control group matching with patients group treated only by pharmacotherapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Drug: Pharmacotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- 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
- 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.
Measured: 14 months
Secondary outcomes (2)
Electroencephalographic (EEG) biofeedback
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 .
Measured: 14 months
General Health Questionnaire (GHQ-12)
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.
- Score from (0-15): normal without distress.
- Score from (16-25): mild distress.
- 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.
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start1 Feb 2023
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElectroencephalographicStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa El sayed Ali Elhout, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840912
- Sponsor's protocol ID
- 36264MS20/1/23
- Status last verified
- Feb 2025
- First submitted
- 12 Feb 2025
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroencephalographic Biofeedback Therapy in Heroin Craving
- ClinicalTrials.gov ID
- NCT06840912
- Acronym / sponsor ID
- 36264MS20/1/23
- Conditions
- Electroencephalographic, Biofeedback Therapy, Heroin, Craving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| EEG biofeedback beside pharmacotherapy group | Experimental | Other: Pharmacological in addition to electroencephalographic (EEG) biofeedbackPatients 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. |
| pharmacotherapy group | Other | Drug: PharmacotherapyPatients 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). |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacological in addition to electroencephalographic (EEG) biofeedbackPatients 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 | EEG biofeedback beside pharmacotherapy group |
| PharmacotherapyAlso: Control groupPatients with heroin use disorder taken as control group matching with patients group treated only by pharmacotherapy | Drug | pharmacotherapy group |
Primary outcome
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.
2 secondary outcomes
Electroencephalographic (EEG) biofeedback
Time frame: 14 months
General Health Questionnaire (GHQ-12)
Time frame: 14 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacological in addition to electroencephalographic (EEG) biofeedback and Pharmacotherapy in people with Electroencephalographic and Biofeedback Therapy, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief substance craving scale( BSCS) (time frame: 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.