MedTrace Logo

Effect of Folic Acid on the Presentation of Nuclear Abnormalities in People With a History Drug Abuse

NCT05712044 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2023-02-03

No results posted yet for this study

Summary

Background: Multiple studies have pointed to the harmful potential of licit and illicit drugs.

as agents associated with neoplastic processes and other non-communicable diseases, for which reason It has become a problem of global size. Objective: The central objective is to determine the cytogenotoxic damage in the oral mucosa of people with chronic drug use, as well as establishing the therapeutic effect of acid administration folic on said damage. Methodology: Quasi-experimental study, pretest-posttest design with no control group.

equivalent, in subjects with substance abuse and healthy subjects. The intervention will consist of administration of 15 mg of folic acid divided into 3 doses per day. Mucosal samples will be taken orally in duplicate to each participant to determine the frequency of micronuclei (MN), bursts cells (NBUD), binucleated cells (BN), condensed chromatin (CC), karyorrhexis (CR), pyknosis (PIC) and caryolysis (CL) at different time events: pre-treatment, 15 days and 30 days. So as a survey to determine consumption patterns of psychoactives, sociodemographic data, dietary and exposure to known cytogenotoxic agents. Resources and infrastructure: The study will be carried out in the pharmacology laboratory of the Center University of Tonalá, who will make their equipment and reagents available. Group experience: The research group has over a decade of experience in the development of projects related to mutagenesis and cyto-genotoxic agents.

Development time: The project will be developed from February 2023 to August of 2023

Conditions

  • Drug Abuse
  • Genotoxicity

Interventions

DRUG

Folic Acid 5 MG

Folic acid 5mg tablets will be administered orally every 8 hours then samples from buccal mucosa will be taken 15 days and 30 days after suplementation.

Sponsors & Collaborators

  • Centro Universitario de Tonalá

    lead OTHER

Principal Investigators

  • Guadalupe Sanchez, PhD · Centro Universitario de Tonalá

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2023-05-01
Completion
2023-08-01

Countries

  • Mexico

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05712044 on ClinicalTrials.gov