Correlation of Genetic Variations With Clinical Response in Substance Use Disorder
NCT ID: NCT05833399
Last Updated: 2023-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2022-11-28
2024-12-31
Brief Summary
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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. 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.
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Detailed Description
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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
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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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.
Quetiapine, olanzapine, mirtazapine, carbamazepine, sertraline, amitriptyline, chlorpromazine and risperidone
Medications are prescribed orally for outpatient or inpatient treatment of addicted patients.
Healthy non-addicted controls.
Individuals who have never been addicted to any substance of use and did not receive any treatment with psychiatric medications.
No interventions assigned to this group
Interventions
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Quetiapine, olanzapine, mirtazapine, carbamazepine, sertraline, amitriptyline, chlorpromazine and risperidone
Medications are prescribed orally for outpatient or inpatient treatment of addicted patients.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients receiving chemotherapy or radiotherapy.
20 Years
60 Years
ALL
Yes
Sponsors
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Alexandria University
OTHER
Responsible Party
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Principal Investigators
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Sahar M El-Gowilly, PhD
Role: PRINCIPAL_INVESTIGATOR
Professor of Pharmacology and Toxicology, Alexandria University
Ahmed F El-Yazbi, PhD
Role: PRINCIPAL_INVESTIGATOR
Professor of Pharmacology and Toxicology, Alexandria University
Noha A Hamdy, PhD
Role: PRINCIPAL_INVESTIGATOR
Lecturer of Clinical Pharmacy and Pharmacy Practice, Alexandria University
Nefertiti A El-Nikhely, PhD
Role: PRINCIPAL_INVESTIGATOR
Associate Professor of Biochemistry, Alexandria University
Aymen H Hamouri, MSc
Role: PRINCIPAL_INVESTIGATOR
Psychiatrist Consultant
Locations
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Alexandria University
Alexandria, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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INTERPAT-VAR-ClinResp-SUD-1
Identifier Type: -
Identifier Source: org_study_id
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