Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
MALE
NCT06550167

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

Led by Distribuidora Biolife SA de CV · Updated on 2024-08-12

80

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Addiction problems to psychoactive substances are becoming more frequent, which implies a serious health problem, with social, family and work repercussions. Participants with chronic consumption present important degeneration processes mediated by Neuroinflammation, oxidative stress and excitotoxicity. At the moment there is no effective treatment that can reduce the damage. The effectiveness of Omega 5 has been demonstrated in different disorders of the nervous system; However, very little has been elucidated about the mechanisms of regulation and activation in consumer patients. Omega 5 Nano-PSO has an important role in mechanisms of cell survival in different pathological events. In this project aims to explain the possible mechanisms underlying the morphological changes and pathologies associated with oxidative stress and inflammation, since it could be a useful strategy to counteract the effects of substances of abuse on brain cells. Omega 5 (Nano PSO) will modify the levels of neurotrophic factors through the decrease in inflammation and reactive oxygen species in patient-consumers of substances, reducing neuronal death and therefore cognitive deterioration. Methodological design Type of study: Clinical trial, randomized controlled, double blind. Research Headquarters: This work will be carried out at the University Center for Health Science with the participation of the "My family is waiting for me" rehabilitation centers. Study Period: 2 years

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 50Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male patients aged 18 to 50 years
  • History of at least 3 years of multiple use of methamphetamines, cocaine, and cannabis, with or without alcohol and tobacco
  • Currently in the withdrawal phase and residential treatment
  • Acceptance and signing of informed consent to participate
Not Eligible

You will not qualify if you...

  • Individuals younger than 18 years
  • Patients who do not sign the informed consent
  • Patients discharged before the 6-month study period, requested by family
  • Patients with known or developed allergies
  • Patients currently using NSAIDs, MAOIs, or with active chronic inflammatory diseases or any type of cancer

AI-Screening

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Trial Site Locations

Total: 1 location

1

Irene Guadalupe Aguilar García PhD.

Guadalajara, Jalisco, Mexico

Actively Recruiting

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Research Team

I

Irene G Aguilar, PH

CONTACT

R

Rolando Castañeda, PH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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