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

NCT06550167 | Recruiting DMC

• 1 other identifier: 23-122
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Addiction, Drug; Neuroprotective; pomegranate seed oil

Outcome Measures

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.

  A BASELINE EVALUATION AND AN EVALUATION AFTER SIX MONTHS OF INTERVENTION

Secondary Outcomes (1)

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

  A BASELINE EVALUATION AND AN EVALUATION AFTER SIX MONTHS OF INTERVENTION

Study Arms (2)

Nano-PSO

EXPERIMENTAL

Nano-PSO or Pomegranate seed oil with nanotechnology, capsules with a net content of 640mg with a dosage indicated by sponsor of 2 capsules in fast

Dietary Supplement: Nano-PSO, Pomegranate seed oil (omega-5)

PLACEBO

PLACEBO COMPARATOR

Placebo physically identical to Nano-PSO capsules Soft gelatin capsules 640 mg edible oil for PLACEBO being the following information: oil edible, oval shape, 640 mg

Other: PLACEBO

Interventions

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.

Also known as: Oil of pomegranate seed with nanotechnology

Nano-PSO

PLACEBO OTHER

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.

PLACEBO

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Distribuidora Biolife SA de CV: lead

Study Sites (1)

Irene Guadalupe Aguilar García PhD.

Guadalajara, Jalisco, Mexico

RECRUITING

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MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Nano-PSO; Nanotechnology

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Miniaturization; Technology; Technology, Industry, and Agriculture

Study Officials

• Irene G Aguilar, PH

  University of Guadalajara

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irene G Aguilar, PH

CONTACT

523313297696; irene.agarcia@academicos.udg.mx

Rolando Castañeda, PH

CONTACT

523312521782; rolando.castaneda@academicos.udg.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The randomized drawing was carried out through the Randomization.com program, which is an online platform that provides randomization services for clinical studies. In addition, the treatments received were previously labeled and randomized by the sponsor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator,

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: August 12, 2024
• Study Start: March 15, 2024
• Primary Completion: March 30, 2026
• Study Completion (Estimated): March 15, 2027
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)