- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05833399
Correlation of Genetic Variations With Clinical Response in Substance Use Disorder
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Ahmed F El-Yazbi, PhD
- Phone Number: +201155881772
- Email: ahmed.fawzy.aly@alexu.edu.eg
Study Contact Backup
- Name: Hebat-ALLAH I Mandour, MSc
- Phone Number: +201223342903
- Email: hebamandour24@gmail.com
Study Locations
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-
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Alexandria, Egypt
- Recruiting
- Alexandria University
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Contact:
- Ahmed F El-Yazbi, PhD
- Phone Number: +201155881772
- Email: ahmed.fawzy.aly@alexu.edu.eg
-
Contact:
- Hebat-ALLAH I Mandour, MSc
- Phone Number: +201223342903
- Email: hebamandour24@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Addicted patients receiving outpatient or inpatient treatment for SUD with or without psychiatric disorders at a mental health care facility.
Exclusion Criteria:
- Patients with renal or hepatic impairment.
- Patients receiving chemotherapy or radiotherapy.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
Medications are prescribed orally for outpatient or inpatient treatment of addicted patients.
Other Names:
|
Healthy non-addicted controls.
Individuals who have never been addicted to any substance of use and did not receive any treatment with psychiatric medications.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacogenomic analysis of SUD and medications used for the treatment of SUD.
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Identification of novel genetic variations related to SUD specifically in the Egyptian population.
Time Frame: 1 year
|
1 year
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Validation of currently known genetic variations associated with SUD.
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sahar M El-Gowilly, PhD, Professor of Pharmacology and Toxicology, Alexandria University
- Principal Investigator: Ahmed F El-Yazbi, PhD, Professor of Pharmacology and Toxicology, Alexandria University
- Principal Investigator: Noha A Hamdy, PhD, Lecturer of Clinical Pharmacy and Pharmacy Practice, Alexandria University
- Principal Investigator: Nefertiti A El-Nikhely, PhD, Associate Professor of Biochemistry, Alexandria University
- Principal Investigator: Aymen H Hamouri, MSc, Psychiatrist Consultant
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antiemetics
- Gastrointestinal Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Dopamine Agents
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Dopamine Antagonists
- Anti-Anxiety Agents
- Anticonvulsants
- Antidepressive Agents, Tricyclic
- Sodium Channel Blockers
- Antimanic Agents
- Cytochrome P-450 Enzyme Inducers
- Serotonin 5-HT3 Receptor Antagonists
- Cytochrome P-450 CYP3A Inducers
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Adrenergic Uptake Inhibitors
- Adrenergic alpha-Antagonists
- Adrenergic alpha-2 Receptor Antagonists
- Olanzapine
- Sertraline
- Quetiapine Fumarate
- Risperidone
- Amitriptyline
- Mirtazapine
- Carbamazepine
- Chlorpromazine
Other Study ID Numbers
- INTERPAT-VAR-ClinResp-SUD-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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