Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Not Yet Recruiting NCT05712044

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

Conditions: Drug Abuse, Genotoxicity

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 45
Sponsor: Centro Universitario de Tonalá

Location: Mexico

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

Eligibility Criteria

Inclusion criteria:Being 18 years of age or olderHaving used legal and illegal drugs.Men or women without diseasesExclusion criteria:People who at the moment of the study or 3 months before:Have consumed any dietary supplement or vitamin such as folates, B12,C, E, A, lutein or melatonin, or some other antioxidant, medications forpharmacological treatment of chronic disease and/or periodontal diseasesevere active.That they were exposed to fertilizers, radiation, metals heavy or who live in areas with high levels of air pollution (Tlaquepaque, Miravalle, Las Juntas and Las Pintas).Individuals who after have been informed of the advantages and risks of participating in the study, decide not to be part of this study.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05712044). StuddyBuddy aggregates publicly available trial information.