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

Summary

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

• Addiction;Drug(S);LSD
• Neuroprotective

Interventions

DIETARY_SUPPLEMENT

Nano-PSO, Pomegranate seed oil (omega-5)

During the intervention, Nano-PSO dietary supplement will be administered to the participants in the assigned group. Participants will be followed before and after treatment to assess the effects of Nano-PSO on cognitive status, serum concentrations of trophic factors, and other relevant parameters . This randomized, double-blind, controlled clinical trial design allows for a rigorous evaluation of the potential benefits of Nano-PSO in patients with substance use disorders. The study aims to provide valuable insights into the neuroprotective and cognitive-enhancing properties of Nano-PSO in this population.

OTHER

PLACEBO

In this arm of the study the participants will receive a placebo as a control treatment . The placebo is essential in clinical trials to compare the effects of the active intervention (Nano-PSO) with those of an inert substance.

Sponsors & Collaborators

• Distribuidora Biolife SA de CV

  lead INDUSTRY

Principal Investigators

• Irene G Aguilar, PH · University of Guadalajara

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-15

Primary Completion

2026-03-30

Completion

2027-03-15

Countries

• Mexico

Study Locations