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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-50
SponsorDistribuidora Biolife SA de CV

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Dietary supplement

    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.

  • PLACEBO

    Other intervention

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Nano-PSOExperimental treatment 1 intervention
Group B: PLACEBOPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Serum Brain-derived neurotrophic factor (BDNF) and Vascular endothelial growth factor VEGF Concentrations after treatment

ELISA kittesting will be performed on blood samples to measure BDNF and VEGF concentrations before and after Nano PSO treatment.

Time frame
A BASELINE EVALUATION AND AN EVALUATION AFTER SIX MONTHS OF INTERVENTION

Secondary outcomes

1

Changes in the Montreal Cognitive Assessment (MoCA) after treatment.

A neuropsychological battery will be designed to evaluate different cognitive aspects and the results of (Montreal Cognitive Assessment (MoCA) obtained will be interpreted.

Time frame
A BASELINE EVALUATION AND AN EVALUATION AFTER SIX MONTHS OF INTERVENTION

Other outcomes

Sponsors and contacts

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