Neuroprotective treatment for patients with substance addiction
Official title: 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
Run by Distribuidora Biolife SA de CV · NCT06550167 · Data updated 2026-11-12
This study is testing whether a treatment made from pomegranate seed oil can help people with substance addiction improve their brain health and thinking skills while they are in recovery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | Men only |
| Enrollment | 80 (estimated) |
| Sponsor | Distribuidora Biolife SA de CV Industry-sponsored |
| Locations | 1 site (Guadalajara, Jalisco) |
| Status | Recruiting |
| Started | March 15, 2024 |
| Main results expected | March 30, 2026 |
| Study ends | March 15, 2027 |
| Registry record updated | August 12, 2024 |
| Trial ID | NCT06550167 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are male patients aged 18-50 with a history of multiple substance use and currently in the withdrawal phase of treatment.
✕Probably not a fit
Patients under 18, those with allergies, or those currently taking certain medications or with active chronic diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the neuroprotective effects of Omega 5 (Nano PSO), derived from pomegranate seed oil, in patients who have a history of consuming psychoactive substances such as methamphetamines, cocaine, and cannabis. The trial aims to explore how Omega 5 can reduce neuroinflammation and oxidative stress, which are common in these patients, thereby promoting cell survival and improving cognitive function. Participants will receive either the active treatment or a placebo while undergoing residential treatment for their addiction. The study will assess changes in neurotrophic factors and overall brain health over a six-month period.
Why it matters
Potential benefit: If successful, this treatment could significantly improve brain health and cognitive function in patients recovering from substance addiction.
How similar studies have gone: While the specific application of Omega 5 in this context is novel, similar neuroprotective approaches have shown promise in other neurological conditions.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where it's running
-
Irene Guadalupe Aguilar García PhD.
Guadalajara, Jalisco, Mexico Recruiting
Study contacts
- Principal investigator: Irene G Aguilar, PH — University of Guadalajara
- Study coordinator: Irene G Aguilar, PH
- Email: irene.agarcia@academicos.udg.mx
- Phone: 523313297696
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.