Correlation of Genetic Variations With Clinical Response in Substance Use Disorder

NCT05833399 | Unknown FDA Drug

• 1 other identifier: INTERPAT-VAR-ClinResp-SUD-1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This research outcomes can be summarized as follows:

1. 1.Pharmacogenomic analysis of Substance Use Disorder (SUD) and medications used for the treatment of SUD.
2. 2.Identification of novel genetic variations related to SUD specifically in the Egyptian population.
3. 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.

Conditions

Substance Use Disorders; Substance Dependence

Outcome Measures

Primary Outcomes (1)

• Pharmacogenomic analysis of SUD and medications used for the treatment of SUD.

  1 year

Secondary Outcomes (1)

• Identification of novel genetic variations related to SUD specifically in the Egyptian population.

  1 year

Other Outcomes (1)

• Validation of currently known genetic variations associated with SUD.

  1 year

Study Arms (2)

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.

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.

Interventions

Quetiapine, olanzapine, mirtazapine, carbamazepine, sertraline, amitriptyline, chlorpromazine and risperidone DRUG

Medications are prescribed orally for outpatient or inpatient treatment of addicted patients.

Also known as: Seroquel, Olapex, Remeron, Tegretol, Moodapex, Tryptizol, Neurazine and Apexidone.

Addicted patients on treatment with psychiatric medications.

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Addicted patients receiving outpatient or inpatient treatment for SUD with or without psychiatric disorders at a mental health care facility.

You may not qualify if:

• Patients with renal or hepatic impairment.
• Patients receiving chemotherapy or radiotherapy.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University

Alexandria, Egypt

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Quetiapine Fumarate; Olanzapine; Mirtazapine; Carbamazepine; Sertraline; Amitriptyline; Chlorpromazine; Risperidone

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Dibenzazepines; 1-Naphthylamine; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Dibenzocycloheptenes; Benzocycloheptenes; Phenothiazines; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hebat-ALLAH I Mandour, MSc

CONTACT

+201223342903; hebamandour24@gmail.com

Ahmed F El-Yazbi, PhD

CONTACT

+201155881772; ahmed.fawzy.aly@alexu.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2023
• First Posted: April 27, 2023
• Study Start: November 28, 2022
• Primary Completion: March 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 27, 2023

Record last verified: 2023-03

Locations

EG (1)