Correlation of Genetic Variations With Clinical Response in Substance Use Disorder

April 16, 2023 updated by: Alexandria University

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:

  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.

Study Overview

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

Observational

Enrollment (Anticipated)

200

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

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

Yes

Sampling Method

Probability Sample

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.

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

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

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:
  • Seroquel, Olapex, Remeron, Tegretol, Moodapex, Tryptizol, Neurazine and Apexidone.
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 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

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

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

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)

November 28, 2022

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

April 16, 2023

First Submitted That Met QC Criteria

April 16, 2023

First Posted (Actual)

April 27, 2023

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 16, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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.

Clinical Trials on Substance Use Disorders

Clinical Trials on Quetiapine, olanzapine, mirtazapine, carbamazepine, sertraline, amitriptyline, chlorpromazine and risperidone

3
Subscribe