RecruitingNot ApplicableNCT06550167

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

Neuroprotective Effect of Omega (Nano PSO), Changes in Neurotrophic BDNF and VEGF, and Their Association With Cognitive Status in Patients Who Used to Consume Psychoactive Substances


Sponsor

Distribuidora Biolife SA de CV

Enrollment

80 participants

Start Date

Mar 15, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 50 Years

Inclusion Criteria4

  • 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 Criteria5

  • 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

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Interventions

DIETARY_SUPPLEMENTNano-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.

OTHERPLACEBO

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.


Locations(1)

Irene Guadalupe Aguilar García PhD.

Guadalajara, Jalisco, Mexico

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NCT06550167


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