Substance Use DisordersNCT05833399
Correlation of Genetic Variations With Clinical Response in Substance Use Disorder
An observational study of Substance Use Disorders and Substance Dependence, run by Alexandria University at 1 site in Egypt.
Trial summary
This research outcomes can be summarized as follows: 1. Pharmacogenomic analysis of Substance Use Disorder (SUD) and medications used for the treatment of SUD. 2. Identification of novel genetic variations related to SUD specifically in the Egyptian population. 3. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorders, Substance Dependence
- What is being tested?
- Quetiapine, olanzapine, mirtazapine, carbamazepine, sertraline, amitriptyline, chlorpromazine and risperidone
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Nov 2022to Dec 2024
- Phase
- Observational
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects participating in this study are those receiving outpatient or inpatient programs for the management of SUD with or without psychiatric disorders, supported by the specialized mental health care facility; "Al-Maa'moura Hospital for Psychiatry" in Alexandria, Egypt.
Who may be able to join
- Addicted patients receiving outpatient or inpatient treatment for SUD with or without psychiatric disorders at a mental health care facility.
Who cannot join
- Patients with renal or hepatic impairment.
- Patients receiving chemotherapy or radiotherapy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria University
Alexandria
Hebat-ALLAH I Mandour, MSc, +201223342903, hebamandour24@gmail.com
Ahmed F El-Yazbi, PhD, +201155881772, ahmed.fawzy.aly@alexu.edu.eg
About this study
Official title: Assessment of the Inter-patient Variability in Clinical Response and Correlated Genetic Variations in Substance Use Disorders
This research outcomes can be summarized as follows:
- Pharmacogenomic analysis of Substance Use Disorder (SUD) and medications used for the treatment of SUD.
- Identification of novel genetic variations related to SUD specifically in the Egyptian population.
- Validation of currently known genetic variations associated with SUD. When the functional interpretation of common or rare variants in studied genes becomes available, such pharmacogenomic information can be used to improve pharmacotherapy individualization.
Read the detailed description
This is a correlational cross-sectional study to investigate the correlation of some genetic variants to the predisposition to SUD in addicted patients as well as to the clinical response of the medications they receive as a part of their treatment plan.
Subjects participating in this study are those receiving outpatient or inpatient programs for the management of SUD with or without psychiatric disorders, supported by the specialized mental health care facility; "Al-Maa'moura Hospital for Psychiatry" in Alexandria.
An informed consent is obtained from each participant prior their contribution to the study. Approval from the General Secretariat of Mental Health and Addiction Treatment (GSMHAT), Ministry of Health and Population (MoHP), has been obtained before conducting the study as well as from the Ethics Committee, Faculty of Medicine, Alexandria University.
A minimal total sample size of 100 participants with SUD, male or female, and another 40 controls will be included in the study. This sample size was calculated with the assistance of instructors in the Department of Medical Statistics, Medical Research Institute, Alexandria University. The targeted sample is selected regarding the inclusion and exclusion criteria.
Patients' medical records will be checked to select the medications of interest. The medications selected include those most prescribed by the psychiatrists assigned at the hospital. They include quetiapine, carbamazepine, amitriptyline, olanzapine, sertraline, chlorpromazine, risperidone, and mirtazapine.
A structured questionnaire will be designed for proper patient data collection. It will be validated for its content using the jury method. The reliability, internal consistency of the questionnaire, will be estimated through the calculated value of Cronbach's alpha. Face to face interviewing with the eligibly selected patients will be done after they sign the patient consent. The questionnaire will be divided into sectors regarding the patients' sociodemographic data, their general health condition, their SUD, and the medications they receive for treatment.
Blood samples will be collected from controls and patients receiving their treatment. These samples will be used for preparation of plasma in which the drug levels will be estimated. They will also be used for isolation of DNA to screen selected mutations, sequence selected genes or perform whole genome sequencing.
- Conditions
- Substance Use Disorders, Substance Dependence
- Being tested
- Quetiapine, olanzapine, mirtazapine, carbamazepine, sertraline, amitriptyline, chlorpromazine and risperidone
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quetiapine, olanzapine, mirtazapine, carbamazepine, sertraline, amitriptyline, chlorpromazine and risperidoneDrug
Also called Seroquel, Olapex, Remeron, Tegretol, Moodapex, Tryptizol, Neurazine and Apexidone.
Medications are prescribed orally for outpatient or inpatient treatment of addicted patients.
| Study group | Role | What they receive |
|---|---|---|
| Addicted patients on treatment with psychiatric medications. | Addicted patients receiving treatment with either quetiapine, olanzapine, mirtazapine, carbamazepine, sertraline, amitriptyline, chlorpromazine or risperidone as oral dosage forms of usual prescribed doses for psychiatric disorders. Receives: Drug: Quetiapine, olanzapine, mirtazapine, carbamazepine, sertraline, amitriptyline, chlorpromazine and risperidone | |
| Healthy non-addicted controls. | Individuals who have never been addicted to any substance of use and did not receive any treatment with psychiatric medications. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacogenomic analysis of SUD and medications used for the treatment of SUD.
Measured: 1 year
Secondary outcomes (1)
Identification of novel genetic variations related to SUD specifically in the Egyptian population.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start28 Nov 2022
- Primary completionMar 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sahar M El-Gowilly, PhD, Principal investigator, Professor of Pharmacology and Toxicology, Alexandria UniversityAhmed F El-Yazbi, PhD, Principal investigator, Professor of Pharmacology and Toxicology, Alexandria UniversityNoha A Hamdy, PhD, Principal investigator, Lecturer of Clinical Pharmacy and Pharmacy Practice, Alexandria UniversityNefertiti A El-Nikhely, PhD, Principal investigator, Associate Professor of Biochemistry, Alexandria UniversityAymen H Hamouri, MSc, Principal investigator, Psychiatrist Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833399
- Sponsor's protocol ID
- INTERPAT-VAR-ClinResp-SUD-1
- Status last verified
- Mar 2023
- First submitted
- 16 Apr 2023
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Inter-patient Variability in Clinical Response and Correlated Genetic Variations in Substance Use Disorders
- ClinicalTrials.gov ID
- NCT05833399
- Acronym / sponsor ID
- INTERPAT-VAR-ClinResp-SUD-1
- Conditions
- Substance Use Disorders, Substance Dependence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 27 Apr 2023 (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.
This research outcomes can be summarized as follows:
- Pharmacogenomic analysis of Substance Use Disorder (SUD) and medications used for the treatment of SUD.
- Identification of novel genetic variations related to SUD specifically in the Egyptian population.
- Validation of currently known genetic variations associated with SUD. When the functional interpretation of common or rare variants in studied genes becomes available, such pharmacogenomic information can be used to improve pharmacotherapy individualization.
Detailed description
This is a correlational cross-sectional study to investigate the correlation of some genetic variants to the predisposition to SUD in addicted patients as well as to the clinical response of the medications they receive as a part of their treatment plan.
Subjects participating in this study are those receiving outpatient or inpatient programs for the management of SUD with or without psychiatric disorders, supported by the specialized mental health care facility; "Al-Maa'moura Hospital for Psychiatry" in Alexandria.
An informed consent is obtained from each participant prior their contribution to the study. Approval from the General Secretariat of Mental Health and Addiction Treatment (GSMHAT), Ministry of Health and Population (MoHP), has been obtained before conducting the study as well as from the Ethics Committee, Faculty of Medicine, Alexandria University.
A minimal total sample size of 100 participants with SUD, male or female, and another 40 controls will be included in the study. This sample size was calculated with the assistance of instructors in the Department of Medical Statistics, Medical Research Institute, Alexandria University. The targeted sample is selected regarding the inclusion and exclusion criteria.
Patients' medical records will be checked to select the medications of interest. The medications selected include those most prescribed by the psychiatrists assigned at the hospital. They include quetiapine, carbamazepine, amitriptyline, olanzapine, sertraline, chlorpromazine, risperidone, and mirtazapine.
A structured questionnaire will be designed for proper patient data collection. It will be validated for its content using the jury method. The reliability, internal consistency of the questionnaire, will be estimated through the calculated value of Cronbach's alpha. Face to face interviewing with the eligibly selected patients will be done after they sign the patient consent. The questionnaire will be divided into sectors regarding the patients' sociodemographic data, their general health condition, their SUD, and the medications they receive for treatment.
Blood samples will be collected from controls and patients receiving their treatment. These samples will be used for preparation of plasma in which the drug levels will be estimated. They will also be used for isolation of DNA to screen selected mutations, sequence selected genes or perform whole genome sequencing.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Addicted patients on treatment with psychiatric medications. | – | Drug: Quetiapine, olanzapine, mirtazapine, carbamazepine, sertraline, amitriptyline, chlorpromazine and risperidoneAddicted patients receiving treatment with either quetiapine, olanzapine, mirtazapine, carbamazepine, sertraline, amitriptyline, chlorpromazine or risperidone as oral dosage forms of usual prescribed doses for psychiatric disorders. |
| Healthy non-addicted controls. | – | –Individuals who have never been addicted to any substance of use and did not receive any treatment with psychiatric medications. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects participating in this study are those receiving outpatient or inpatient programs for the management of SUD with or without psychiatric disorders, supported by the specialized mental health care facility; "Al-Maa'moura Hospital for Psychiatry" in Alexandria, Egypt.
Key inclusion criteria (1 listed)
- Addicted patients receiving outpatient or inpatient treatment for SUD with or without psychiatric disorders at a mental health care facility.
Key exclusion criteria (2 listed)
- Patients with renal or hepatic impairment.
- Patients receiving chemotherapy or radiotherapy.
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 |
|---|---|---|
| Quetiapine, olanzapine, mirtazapine, carbamazepine, sertraline, amitriptyline, chlorpromazine and risperidoneAlso: Seroquel, Olapex, Remeron, Tegretol, Moodapex, Tryptizol, Neurazine and Apexidone.Medications are prescribed orally for outpatient or inpatient treatment of addicted patients. | Drug | Addicted patients on treatment with psychiatric medications. |
Primary outcome
Pharmacogenomic analysis of SUD and medications used for the treatment of SUD.
Time frame: 1 year
1 secondary outcome
Identification of novel genetic variations related to SUD specifically in the Egyptian population.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
Sahar M El-Gowilly, PhD principal investigator
Professor of Pharmacology and Toxicology, Alexandria University
Ahmed F El-Yazbi, PhD principal investigator
Professor of Pharmacology and Toxicology, Alexandria University
Noha A Hamdy, PhD principal investigator
Lecturer of Clinical Pharmacy and Pharmacy Practice, Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Use Disorders and Substance Dependence, run by Alexandria 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 27 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hebat-ALLAH I Mandour, MSc (+201223342903, hebamandour24@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacogenomic analysis of SUD and medications used for the treatment of SUD. (time frame: 1 year). 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 27 Apr 2023.