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Search / Trial NCT06550167

Neuroprotective Effect of (Nano PSO), in Patients Who Used to Consume Psychoactive Substances

Launched by DISTRIBUIDORA BIOLIFE SA DE CV · Aug 9, 2024

Trial Information

Current as of August 22, 2025

Recruiting

Keywords

Addiction, Drug Neuroprotective Pomegranate Seed Oil

ClinConnect Summary

This clinical trial is studying the effects of a treatment called Omega 5 (Nano PSO) on men who have been using drugs like methamphetamines, cocaine, and cannabis for a long time. The researchers believe that this treatment could help protect the brain from damage caused by these substances, which often leads to problems like inflammation and stress in the brain. By reducing these harmful effects, the goal is to improve brain health and cognitive function, helping patients recover better while they are in rehabilitation.

To participate in the trial, men aged 18 to 50 who are currently in a residential treatment program for drug use and have been using these substances for at least three years may be eligible. They must also agree to take part in the study by signing a consent form. Participants can expect to receive either the treatment or a placebo (a non-active version) for the next two years while their progress is monitored. Importantly, the trial is being conducted at a health science university and involves rehabilitation centers, ensuring that participants are supported throughout the process.

Gender

MALE

Eligibility criteria

  • Inclusion Criteria:
  • Patients who are multiple users of methamphetamines, cocaine, and cannabis with or without alcohol and tobacco, and have a history of at least 3 years of consumption.
  • Patients who accept informed consent to participate in the protocol.
  • Male gender.
  • Age between 18-50 years in the withdrawal phase currently in residential treatment
  • Exclusion Criteria:
  • Individuals under 18 years of age.
  • Patients who do not sign the informed consent.
  • Discharge of patients prior to the stipulated 6 months, requested by family members.
  • Patients with developed or known allergies.
  • Patients who are consuming NSAIDs, MAOIs (monoamine oxidase Inhibitor), active chronic inflammatory diseases, or any type of cancer

About Distribuidora Biolife Sa De Cv

Distribuidora BioLife SA de CV is a leading clinical trial sponsor dedicated to advancing biopharmaceutical innovation through rigorous research and development. With a commitment to improving patient outcomes, the organization specializes in the distribution and clinical evaluation of cutting-edge therapies and medical products. Leveraging a robust network of healthcare professionals and research institutions, BioLife ensures compliance with regulatory standards while fostering collaboration to enhance the efficiency and efficacy of clinical trials. Their mission is to bring transformative health solutions to market, prioritizing safety, quality, and ethical practices in all undertakings.

Locations

Guadalajara, Jalisco, Mexico

Patients applied

0 patients applied

Trial Officials

Irene G Aguilar, PH

Principal Investigator

University of Guadalajara

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported