Addiction;Drug(S);LSDNCT06550167
Neuroprotective Effect of (Nano PSO), in Patients Who Used to Consume Psychoactive Substances
A study testing Nano-PSO, Pomegranate seed oil (omega-5) in people with Addiction;Drug(S);LSD and Neuroprotective, run by Distribuidora Biolife SA de CV at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Addiction;Drug(S);LSD, Neuroprotective
- What is being tested?
- Nano-PSO, Pomegranate seed oil (omega-5)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteMexico
- Study dates
- 15 Mar 2024to 15 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Irene Guadalupe Aguilar García PhD.
Guadalajara, Jalisco
Irene G Aguilar García, PH, 3313297696, irene.agarcia@academicos.udg.mx
About this study
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
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
Read the detailed description
Omega 5 (Nano PSO) has been shown to be a powerful antioxidant with neuroprotective and anti-inflammatory effects in various neurological and neurodegenerative diseases. In patients who consume psychoactive substances, who present high levels of neuroinflammation and oxidative stress, Omega 5 could help to reduce damage on neuronal and glial cells, promoting cell survival and preserving a homeostatic microenvironment in the brain.
It has been suggested that Omega 5 could modify the levels of neurotrophic factors such as BDNF and VEGF, which might contribute to the protection of brain cells and the improvement of cognitive status in substance abuse patients. In addition, it has been mentioned that Omega 5 acts through the reduction of inflammation and reactive oxygen species, which could reduce neuronal death and prevent cognitive deterioration in these patients.
In summary, Omega 5 (Nano PSO) seems to play an important role in protecting the brain cells of patients who consume psychoactive substances by acting as an antioxidant and anti-inflammatory, modulating neurotrophic factors and promoting cell survival in a brain environment affected by substance consumption.
It has been investigated that Omega 5 (Nano PSO) exerts its beneficial effects through various regulation and activation mechanisms in patients who consume psychoactive substances:
- Modulation of neurotrophic factors: It has been suggested that Omega 5 can modify the levels of neurotrophic factors such as brain-derived neurotrophic factor (BDNF) and vascular endothelial growth factor (VEGF) in patients who consume psychoactive substances. These factors play a crucial role in the neuroprotection, and its modulation by Omega 5 could contribute to the improvement of cognitive status and cell survival in these patients.
- Antioxidant and anti-inflammatory action: Omega 5 has been shown to have antioxidant and anti-inflammatory effects in several pathologies of the nervous system. In patients who consume psychoactive substances, who have high levels of neuroinflammation and oxidative stress, Omega 5 can help reduce damage to neuronal and glial cells, promoting cell survival and preserving a homeostatic brain environment.
- Protection against oxidative stress: It has been suggested that Omega 5 may be useful to reduce the damage caused by oxidative stress at the brain level in substance abuse patients. By acting as an antioxidant, Omega 5 could counteract the negative effects of oxidative stress on brain cells and contribute to neuronal protection.
- Conditions
- Addiction;Drug(S);LSD, Neuroprotective
- Being tested
- Nano-PSO, Pomegranate seed oil (omega-5), PLACEBO
- Keywords
- Addiction, Drug, Neuroprotective, pomegranate seed oil
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nano-PSO, Pomegranate seed oil (omega-5)Dietary supplement
Also called Oil of pomegranate seed with nanotechnology
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.
PLACEBOOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: A BASELINE EVALUATION AND AN EVALUATION AFTER SIX MONTHS OF INTERVENTION
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start15 Mar 2024
- Primary completion30 Mar 2026 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Addiction;Drug(S);LSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Distribuidora Biolife SA de CV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Irene Guadalupe Aguilar García, Distribuidora Biolife SA de CV
- Investigators
- Irene G Aguilar, PH, Principal investigator, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550167
- Sponsor's protocol ID
- 23-122
- Status last verified
- Aug 2024
- First submitted
- 13 Jun 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdel-Zaher AO, Mostafa MG, Farghly HM, Hamdy MM, Omran GA, Al-Shaibani NK. Inhibition of brain oxidative stress and inducible nitric oxide synthase expression by thymoquinone attenuates the development of morphine tolerance and dependence in mice. Eur J Pharmacol. 2013 Feb 28;702(1-3):62-70. doi: 10.1016/j.ejphar.2013.01.036. Epub 2013 Jan 30.
PubMed 23376567Abdel-Zaher AO, Mostafa MG, Farghaly HS, Hamdy MM, Abdel-Hady RH. Role of oxidative stress and inducible nitric oxide synthase in morphine-induced tolerance and dependence in mice. Effect of alpha-lipoic acid. Behav Brain Res. 2013 Jun 15;247:17-26. doi: 10.1016/j.bbr.2013.02.034. Epub 2013 Mar 5.
PubMed 23470902Adu-Frimpong M, Firempong CK, Omari-Siaw E, Wang Q, Mukhtar YM, Deng W, Yu Q, Xu X, Yu J. Preparation, optimization, and pharmacokinetic study of nanoliposomes loaded with triacylglycerol-bound punicic acid for increased antihepatotoxic activity. Drug Dev Res. 2019 Mar;80(2):230-245. doi: 10.1002/ddr.21485. Epub 2018 Nov 10.
PubMed 30414214Andreska T, Aufmkolk S, Sauer M, Blum R. High abundance of BDNF within glutamatergic presynapses of cultured hippocampal neurons. Front Cell Neurosci. 2014 Apr 11;8:107. doi: 10.3389/fncel.2014.00107. eCollection 2014.
PubMed 24782711Aruna P, Venkataramanamma D, Singh AK, Singh RP. Health Benefits of Punicic Acid: A Review. Compr Rev Food Sci Food Saf. 2016 Jan;15(1):16-27. doi: 10.1111/1541-4337.12171. Epub 2015 Oct 21.
PubMed 33371578Berrios-Carcamo P, Quezada M, Quintanilla ME, Morales P, Ezquer M, Herrera-Marschitz M, Israel Y, Ezquer F. Oxidative Stress and Neuroinflammation as a Pivot in Drug Abuse. A Focus on the Therapeutic Potential of Antioxidant and Anti-Inflammatory Agents and Biomolecules. Antioxidants (Basel). 2020 Sep 4;9(9):830. doi: 10.3390/antiox9090830.
PubMed 32899889Castillo-Navarrete JL, Guzman-Castillo A, Bustos C, Rojas R. Peripheral brain-derived neurotrophic factor (BDNF) and salivary cortisol levels in college students with different levels of academic stress. Study protocol. PLoS One. 2023 Feb 22;18(2):e0282007. doi: 10.1371/journal.pone.0282007. eCollection 2023.
PubMed 36812175Cai Y, Yang L, Hu G, Chen X, Niu F, Yuan L, Liu H, Xiong H, Arikkath J, Buch S. Regulation of morphine-induced synaptic alterations: Role of oxidative stress, ER stress, and autophagy. J Cell Biol. 2016 Oct 24;215(2):245-258. doi: 10.1083/jcb.201605065. Epub 2016 Oct 17.
PubMed 27810915Famitafreshi H, Karimian M. Socialization Alleviates Burden of Oxidative-Stress in Hippocampus and Prefrontal Cortex in Morphine Addiction Period in Male Rats. Curr Mol Pharmacol. 2018;11(3):254-259. doi: 10.2174/1874467210666170919161045.
PubMed 28933310George O, Koob GF. Individual differences in prefrontal cortex function and the transition from drug use to drug dependence. Neurosci Biobehav Rev. 2010 Nov;35(2):232-47. doi: 10.1016/j.neubiorev.2010.05.002. Epub 2010 May 20.
PubMed 20493211Guerra-Vazquez CM, Martinez-Avila M, Guajardo-Flores D, Antunes-Ricardo M. Punicic Acid and Its Role in the Prevention of Neurological Disorders: A Review. Foods. 2022 Jan 18;11(3):252. doi: 10.3390/foods11030252.
PubMed 35159404Guillin O, Diaz J, Carroll P, Griffon N, Schwartz JC, Sokoloff P. BDNF controls dopamine D3 receptor expression and triggers behavioural sensitization. Nature. 2001 May 3;411(6833):86-9. doi: 10.1038/35075076.
PubMed 11333982Grimm JW, Lu L, Hayashi T, Hope BT, Su TP, Shaham Y. Time-dependent increases in brain-derived neurotrophic factor protein levels within the mesolimbic dopamine system after withdrawal from cocaine: implications for incubation of cocaine craving. J Neurosci. 2003 Feb 1;23(3):742-7. doi: 10.1523/JNEUROSCI.23-03-00742.2003.
PubMed 12574402Horger BA, Iyasere CA, Berhow MT, Messer CJ, Nestler EJ, Taylor JR. Enhancement of locomotor activity and conditioned reward to cocaine by brain-derived neurotrophic factor. J Neurosci. 1999 May 15;19(10):4110-22. doi: 10.1523/JNEUROSCI.19-10-04110.1999.
PubMed 10234039Jang EY, Yang CH, Hedges DM, Kim SP, Lee JY, Ekins TG, Garcia BT, Kim HY, Nelson AC, Kim NJ, Steffensen SC. The role of reactive oxygen species in methamphetamine self-administration and dopamine release in the nucleus accumbens. Addict Biol. 2017 Sep;22(5):1304-1315. doi: 10.1111/adb.12419. Epub 2016 Jul 14.
PubMed 27417190
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06550167
- Acronym / sponsor ID
- 23-122
- Conditions
- Addiction;Drug(S);LSD, Neuroprotective
- Keywords
- Addiction, Drug, Neuroprotective, pomegranate seed oil
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Distribuidora Biolife SA de CVIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 12 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Omega 5 (Nano PSO) has been shown to be a powerful antioxidant with neuroprotective and anti-inflammatory effects in various neurological and neurodegenerative diseases. In patients who consume psychoactive substances, who present high levels of neuroinflammation and oxidative stress, Omega 5 could help to reduce damage on neuronal and glial cells, promoting cell survival and preserving a homeostatic microenvironment in the brain.
It has been suggested that Omega 5 could modify the levels of neurotrophic factors such as BDNF and VEGF, which might contribute to the protection of brain cells and the improvement of cognitive status in substance abuse patients. In addition, it has been mentioned that Omega 5 acts through the reduction of inflammation and reactive oxygen species, which could reduce neuronal death and prevent cognitive deterioration in these patients.
In summary, Omega 5 (Nano PSO) seems to play an important role in protecting the brain cells of patients who consume psychoactive substances by acting as an antioxidant and anti-inflammatory, modulating neurotrophic factors and promoting cell survival in a brain environment affected by substance consumption.
It has been investigated that Omega 5 (Nano PSO) exerts its beneficial effects through various regulation and activation mechanisms in patients who consume psychoactive substances:
- Modulation of neurotrophic factors: It has been suggested that Omega 5 can modify the levels of neurotrophic factors such as brain-derived neurotrophic factor (BDNF) and vascular endothelial growth factor (VEGF) in patients who consume psychoactive substances. These factors play a crucial role in the neuroprotection, and its modulation by Omega 5 could contribute to the improvement of cognitive status and cell survival in these patients.
- Antioxidant and anti-inflammatory action: Omega 5 has been shown to have antioxidant and anti-inflammatory effects in several pathologies of the nervous system. In patients who consume psychoactive substances, who have high levels of neuroinflammation and oxidative stress, Omega 5 can help reduce damage to neuronal and glial cells, promoting cell survival and preserving a homeostatic brain environment.
- Protection against oxidative stress: It has been suggested that Omega 5 may be useful to reduce the damage caused by oxidative stress at the brain level in substance abuse patients. By acting as an antioxidant, Omega 5 could counteract the negative effects of oxidative stress on brain cells and contribute to neuronal protection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nano-PSO | Experimental | Dietary Supplement: Nano-PSO, Pomegranate seed oil (omega-5)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 |
| PLACEBO | Placebo comparator | Other: PLACEBOPlacebo 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nano-PSO, Pomegranate seed oil (omega-5)Also: Oil of pomegranate seed with nanotechnologyDuring 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. | Dietary supplement | Nano-PSO |
| PLACEBOIn 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. | Other | PLACEBO |
Primary outcome
Serum Brain-derived neurotrophic factor (BDNF) and Vascular endothelial growth factor VEGF Concentrations after treatment
Time frame: A BASELINE EVALUATION AND AN EVALUATION AFTER SIX MONTHS OF INTERVENTION
ELISA kittesting will be performed on blood samples to measure BDNF and VEGF concentrations before and after Nano PSO treatment.
1 secondary outcome
Changes in the Montreal Cognitive Assessment (MoCA) after treatment.
Time frame: A BASELINE EVALUATION AND AN EVALUATION AFTER SIX MONTHS OF INTERVENTION
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Results publication: PubMed 23376567Abdel-Zaher AO, Mostafa MG, Farghly HM, Hamdy MM, Omran GA, Al-Shaibani NK. Inhibition of brain oxidative stress and inducible nitric oxide synthase expression by thymoquinone attenuates the development of morphine tolerance and dependence in mice. Eur J Pharmacol. 2013 Feb 28;702(1-3):62-70. doi: 10.1016/j.ejphar.2013.01.036. Epub 2013 Jan 30.
- Results publication: PubMed 23470902Abdel-Zaher AO, Mostafa MG, Farghaly HS, Hamdy MM, Abdel-Hady RH. Role of oxidative stress and inducible nitric oxide synthase in morphine-induced tolerance and dependence in mice. Effect of alpha-lipoic acid. Behav Brain Res. 2013 Jun 15;247:17-26. doi: 10.1016/j.bbr.2013.02.034. Epub 2013 Mar 5.
- Results publication: PubMed 30414214Adu-Frimpong M, Firempong CK, Omari-Siaw E, Wang Q, Mukhtar YM, Deng W, Yu Q, Xu X, Yu J. Preparation, optimization, and pharmacokinetic study of nanoliposomes loaded with triacylglycerol-bound punicic acid for increased antihepatotoxic activity. Drug Dev Res. 2019 Mar;80(2):230-245. doi: 10.1002/ddr.21485. Epub 2018 Nov 10.
- Results publication: PubMed 24782711Andreska T, Aufmkolk S, Sauer M, Blum R. High abundance of BDNF within glutamatergic presynapses of cultured hippocampal neurons. Front Cell Neurosci. 2014 Apr 11;8:107. doi: 10.3389/fncel.2014.00107. eCollection 2014.
- Results publication: PubMed 33371578Aruna P, Venkataramanamma D, Singh AK, Singh RP. Health Benefits of Punicic Acid: A Review. Compr Rev Food Sci Food Saf. 2016 Jan;15(1):16-27. doi: 10.1111/1541-4337.12171. Epub 2015 Oct 21.
- Results publication: PubMed 32899889Berrios-Carcamo P, Quezada M, Quintanilla ME, Morales P, Ezquer M, Herrera-Marschitz M, Israel Y, Ezquer F. Oxidative Stress and Neuroinflammation as a Pivot in Drug Abuse. A Focus on the Therapeutic Potential of Antioxidant and Anti-Inflammatory Agents and Biomolecules. Antioxidants (Basel). 2020 Sep 4;9(9):830. doi: 10.3390/antiox9090830.
- Results publication: PubMed 36812175Castillo-Navarrete JL, Guzman-Castillo A, Bustos C, Rojas R. Peripheral brain-derived neurotrophic factor (BDNF) and salivary cortisol levels in college students with different levels of academic stress. Study protocol. PLoS One. 2023 Feb 22;18(2):e0282007. doi: 10.1371/journal.pone.0282007. eCollection 2023.
- Results publication: PubMed 27810915Cai Y, Yang L, Hu G, Chen X, Niu F, Yuan L, Liu H, Xiong H, Arikkath J, Buch S. Regulation of morphine-induced synaptic alterations: Role of oxidative stress, ER stress, and autophagy. J Cell Biol. 2016 Oct 24;215(2):245-258. doi: 10.1083/jcb.201605065. Epub 2016 Oct 17.
- Results publication: PubMed 28933310Famitafreshi H, Karimian M. Socialization Alleviates Burden of Oxidative-Stress in Hippocampus and Prefrontal Cortex in Morphine Addiction Period in Male Rats. Curr Mol Pharmacol. 2018;11(3):254-259. doi: 10.2174/1874467210666170919161045.
- Results publication: PubMed 20493211George O, Koob GF. Individual differences in prefrontal cortex function and the transition from drug use to drug dependence. Neurosci Biobehav Rev. 2010 Nov;35(2):232-47. doi: 10.1016/j.neubiorev.2010.05.002. Epub 2010 May 20.
- Results publication: PubMed 35159404Guerra-Vazquez CM, Martinez-Avila M, Guajardo-Flores D, Antunes-Ricardo M. Punicic Acid and Its Role in the Prevention of Neurological Disorders: A Review. Foods. 2022 Jan 18;11(3):252. doi: 10.3390/foods11030252.
- Results publication: PubMed 11333982Guillin O, Diaz J, Carroll P, Griffon N, Schwartz JC, Sokoloff P. BDNF controls dopamine D3 receptor expression and triggers behavioural sensitization. Nature. 2001 May 3;411(6833):86-9. doi: 10.1038/35075076.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Irene G Aguilar, PH principal investigator
University of Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nano-PSO, Pomegranate seed oil (omega-5) in people with Addiction;Drug(S);LSD and Neuroprotective, run by Distribuidora Biolife SA de CV at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Irene G Aguilar, PH (523313297696, irene.agarcia@academicos.udg.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Brain-derived neurotrophic factor (BDNF) and Vascular endothelial growth factor VEGF Concentrations after treatment (time frame: A BASELINE EVALUATION AND AN EVALUATION AFTER SIX MONTHS OF INTERVENTION). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06550167, which also lists 37 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.