Opioid AddictionMED-DOPENCT07022782
MEDiterranean Diet-driven Detoxification of OPioid Addicted patiEnts (MED-DOPE)
A study testing A nutritional intervention based on the principles of Mediterranean diet in people with Opioid Addiction, run by Aristidis Veskoukis at 1 site in Greece.
Trial summary
The MED-DOPE (MEDiterranean diet-driven Detoxification of OPioid addicted patiEnts) study is a randomized controlled trial that aims to investigate the role of a nutritional intervention based on the principles of Mediterranean diet on craving, which is the primary outcome, and blood redox status of opioid-addicted… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Opioid Addiction
- What is being tested?
- A nutritional intervention based on the principles of Mediterranean diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- 10 Mar 2025to May 2026
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 20 years of age
- Long-term heroine or other opioid drug use
- Suffering from physical and mental dependence due to chronic opioid use
Who cannot join
- Serious medical problems, such as infection by human immunodeficiency virus or hepatitis B virus
- Current use of anti-inflammatory medication
- Relapse to other addictive substances (i.e., opioids, methamphetamine, benzodiazepines, cannabis, tetrahydrocannabinol, amphetamine) - To rule out the use of such substances, all participants will undergo weekly urine tests during the three-month period of the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Nutritional Intervention Based on the Principles of Mediterranean Diet as a Putative Regulator of Craving and Redox Status of Patients Under Medication-assisted Treatment With Methadone and Buprenorphine: The Study Protocol of a Randomized Controlled Trial (the MED-DOPE Study)
The MED-DOPE (MEDiterranean diet-driven Detoxification of OPioid addicted patiEnts) study is a randomized controlled trial that aims to investigate the role of a nutritional intervention based on the principles of Mediterranean diet on craving, which is the primary outcome, and blood redox status of opioid-addicted patients under medication-assisted treatment with buprenorphine and methadone. In detail, the patients of the intervention group will consume three meals per day (i.e., breakfast, lunch and dinner) based on the principles of Mediterranean diet for 90 days. The patients of the control group will follow their normal nutritional habits. Craving as the primary outcome, quality of sleep and biochemical parameters such as blood redox status will be evaluated. It is hypothesized that the applied nutritional intervention will reduce craving, probably through the improvement of blood redox status, of the patients of the intervention group compared to the patients of the control group.
Read the detailed description
Background: Methadone and buprenorphine are considered as the "gold standard" medication-assisted treatment (MAT) for patients with opioid use disorders (OUDs). Patients who suffer from OUDs usually experience serious health consequences in the psychosocial and the biochemical level. Specifically, they are at 10-fold higher mortality risk than those of the general population. Moreover, there are inconsistencies related to the efficacy of MAT (i.e., methadone and buprenorphine) on retention to treatment and opioid craving, that is a major psychosocial parameter to be improved towards successful rehabilitation. Craving is a central psychosocial component for addiction characterized by a strong urge to use an illicit substance that induces addiction. It appears that although MAT partially normalizes this parameter, patients with OUDs continue to experience craving for opioids leading to drug-seeking behavior and relapse. Furthermore, opioids such as heroine induce oxidative stress, a common toxic biochemical outcome. However, this is the case also for methadone and buprenorphine, although in a lower extent compared to heroine. Therefore, opioid-addiction induced oxidative stress seems to be rather neglected and needs further attention. Oxidative stress is a result of excessive reactive oxygen species generation, which may cause protein and lipid oxidation and oxidative modification of DNA. To that end, the use of plant-derived compounds as auxiliary therapeutic approaches, in combination with methadone and buprenorphine could be a promising approach towards enhancement of the effectiveness of MAT. The biological plausibility for the adoption of such a nutritional practice relies on the fact that plant components namely polyphenols exert potent antioxidant properties against oxidative stress. It has been clearly shown that pomegranate juice is such a physical product. A nutritional approach on the basis of Mediterranean diet could also be considered as an alternative approach towards rehabilitation from addiction to opioids. Indeed, Mediterranean diet has been associated with better health outcomes. Its beneficial effects on human health have largely been attributed to the antioxidant properties of its components, mainly polyphenols.
Objectives: The MED-DOPE (MEDiterranean diet-driven Detoxification of OPioid addicted patiEnts) study aims to investigate the role of a nutritional intervention based on the principles of Mediterranean diet on craving and blood redox status of patients with OUDs under buprenorphine and methadone. This diet scheme is rich in antioxidant compounds that, along with medication (i.e., methadone and buprenorphine), could putatively act beneficially on several health parameters of the patients with OUDs.
Methods: Three meals (i.e., breakfast, lunch and dinner) will be administered daily for 90 days to patients with OUDs under methadone and buprenorphine. In two time points namely Days 1 and 90 the patients will form the heroine craving questionnaire to assess craving, which is the primary outcome of MED-DOPE study. Blood samples will also be collected from the participants in order to measure redox biomarkers (i.e., glutathione concentration, total antioxidant capacity, concentraiton of protein carbonyls, glutathione reductase activity and glutathione peroxidase activity).
Anticipated Outcome: It is hypothesized that the applied nutritional intervention will reduce craving probably through the improvement of blood redox status.
Conclusion: MED-DOPE is a hypothesis-driven and evidence-based project that proposes a nutrition-based solution for craving amelioration in patients with OUDs under MAT, potentially assisting towards their successful rehabilitation and societal reintegration.
- Conditions
- Opioid Addiction
- Being tested
- A nutritional intervention based on the principles of Mediterranean diet
- Keywords
- Mediterranean diet, Opioid use disorders, Methadone, Buprenorphine, Oxidative stress, Antioxidants, Nutrition, Craving
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A nutritional intervention based on the principles of Mediterranean dietOther
The patients will consume meals three times (i.e., breakfast, lunch and dinner) per day for 90 days (i.e., three months) that are based on the principles of Mediterranean diet.
| Study group | Role | What they receive |
|---|---|---|
| Intervention - Nutrition | Experimental | The intevention group will comprise patients under medication-assisted treatment (MAT) who are active members of the therapeutic units of the Greek Organization Against Drugs (OKANA). The participants will be stratified into two subgroups, i.e., methadone maintenance treatment (MMT) and buprenorphine maintenance treatment (BMT), according to the maintenance treatment program they attend. The nutritional intervention based on the principles of Mediterranean diet will be administered to the participants of both MMT and BMT subgroups of the intervention group. The patients will consume meals three times (i.e., breakfast, lunch and dinner) per day for 90 days (i.e., three months). Receives: Other: A nutritional intervention based on the principles of Mediterranean diet |
| No intervention - Control group | No intervention | The control group will comprise patients under medication-assisted treatment (MAT) who are active members of the therapeutic units of the Greek Organization Against Drugs (OKANA). The participants will be stratified into two subgroups, i.e., methadone maintenance treatment (MMT) and buprenorphine maintenance treatment (BMT), according to the maintenance treatment program they attend. No intervention wil be applied. The patients will follow their normal nutritional habbits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Craving
The effects of the applied nutritional intervention on craving will be assessed through the Heroin Craving Questionnaire (HCQ), which is a validated self-reported instrument. It is consisted of 45 questions divided in 5 dimensions, namely desire to use heroine, intentions and planning to use heroine, anticipation of positive outcome, relief from withdrawal or dysphoria, and lack of control overuse. The score is calculated with a 7-point Likert scale ranging from 1 (i.e., strongly disagree) to 7 (i.e., strongly agree) and the higher the score, the worse the outcome. HCQ will be completed by the volunteers of both the experimental and control groups at two timepoints as follows: Before the start of the experiment (i.e., Day 1 or pre) and at the end of the experiment (i.e., day 90 or post).
Measured: Changes between Day 1 (pre) and Day 90 (post) will be assessed.
Secondary outcomes (6)
Quality of Sleep
Quality of sleep of the patients will be assessed through the Pittsburgh Sleep Quality Index (PSQI), which is a 19-item self-reported questionnaire. It subjectively assesses sleep quality and quantity, sleep habits related to quality and occurrence of sleep disturbances in adults. It is consisted by 7 components, each of which has a score that is marked on a 0-3-Likert scale. Finally, the PSQI is calculated as the sum of the 7 components ranging between 0 and 21. Higher obtained scores indicate increased sleep complaints and lower sleep quality.
Measured: Changes between Day 1 (pre) and Day 90 (post) will be assessed.
Blood GSH concentration
The concentration of reduced form of glutathione (GSH) as a crucial intrinsic antioxidant metabolite will be measured spectrophotometrically in erythrocytes.
Measured: Changes in GSH concentration will be compared between Day 1 (pre) and Day 90 (post).
Concentration of protein carbonyls in blood
The concentration of protein carbonyls, as a biomarker of protein oxidation, will be evaluated spectrophotometrically in plasma.
Measured: Changes in protein carbonyl concentration will be compared between Day 1 (pre) and Day 90 (post).
Total antioxidant capacity of blood
Total antioxidant capacity (TAC) will be evaluated spectrophotometrically in plasma.
Measured: Changes in TAC will be compared between Day 1 (pre) and Day 90 (post).
Activity of glutathione reductase
The activity of glutathione reductase as an antioxidant enzyme will be measured in erythrocytes.
Measured: Changes in glutathione reductase activity will be compared between Day 1 (pre) and Day 90 (post).
Activity of glutathione peroxidase
The activity of glutathione peroxidase as an antioxidant enzyme will be measured in erythrocytes.
Measured: Changes in glutathione peroxidase activity will be compared between Day 1 (pre) and Day 90 (post).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start10 Mar 2025
- Primary completion18 Aug 2025
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Opioid AddictionStudies 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
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristidis Veskoukis
- Sponsor type
- University, hospital or other
- Collaborators
- Organization Against Drugs (OKANA)
- Responsible party
- Sponsor-investigator, Aristidis Veskoukis, University of Thessaly
- Investigators
- Christonikos Leventelis, Principal investigator, Organization Against Drugs (OKANA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022782
- Sponsor's protocol ID
- 48383/3-2-2022
- Acronym
- MED-DOPE
- Status last verified
- Jun 2025
- First submitted
- 7 Jun 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this investigation will be provided, upon request respecting GDPR, to qualified researchers and clinicians with related academic interest.
Publications
Veskoukis AS, Tsatsakis AM, Kouretas D. Dietary oxidative stress and antioxidant defense with an emphasis on plant extract administration. Cell Stress Chaperones. 2012 Jan;17(1):11-21. doi: 10.1007/s12192-011-0293-3. Epub 2011 Sep 30.
PubMed 21956695Leventelis C, Makri S, Ververi A, Papageorgiou K, Tentolouri A, Mountzouridi E, Tekos F, Barmpas PT, Tasoulis S, Metsios GS, Kouretas D, Veskoukis AS. Pomegranate juice ameliorates craving and oxidative stress on patients under medication for opioid addiction treatment with methadone and buprenorphine: A ranzomised controlled trial. Clin Nutr ESPEN. 2025 Apr;66:34-45. doi: 10.1016/j.clnesp.2025.01.025. Epub 2025 Jan 10.
PubMed 39798867Leventelis C, Goutzourelas N, Kortsinidou A, Spanidis Y, Toulia G, Kampitsi A, Tsitsimpikou C, Stagos D, Veskoukis AS, Kouretas D. Buprenorphine and Methadone as Opioid Maintenance Treatments for Heroin-Addicted Patients Induce Oxidative Stress in Blood. Oxid Med Cell Longev. 2019 Apr 9;2019:9417048. doi: 10.1155/2019/9417048. eCollection 2019.
PubMed 31093318Estruch R, Ros E, Salas-Salvado J, Covas MI, Corella D, Aros F, Gomez-Gracia E, Ruiz-Gutierrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pinto X, Basora J, Munoz MA, Sorli JV, Martinez JA, Fito M, Gea A, Hernan MA, Martinez-Gonzalez MA; PREDIMED Study Investigators. Primary Prevention of Cardiovascular Disease with a Mediterranean Diet Supplemented with Extra-Virgin Olive Oil or Nuts. N Engl J Med. 2018 Jun 21;378(25):e34. doi: 10.1056/NEJMoa1800389. Epub 2018 Jun 13.
PubMed 29897866Billingsley HE, Carbone S. The antioxidant potential of the Mediterranean diet in patients at high cardiovascular risk: an in-depth review of the PREDIMED. Nutr Diabetes. 2018 Mar 9;8(1):13. doi: 10.1038/s41387-018-0025-1.
PubMed 29549354Arezoomandan M, Zhiani R, Mehrzad J, Motavalizadehkakhky A, Eshrati S, Arezoomandan R. Inflammatory, oxidative stress and cognitive functions in patients under maintenance treatment with methadone or buprenorphine and healthy subjects. J Clin Neurosci. 2022 Jul;101:57-62. doi: 10.1016/j.jocn.2022.04.018. Epub 2022 May 6.
PubMed 35533613Aleksandrova K, Koelman L, Rodrigues CE. Dietary patterns and biomarkers of oxidative stress and inflammation: A systematic review of observational and intervention studies. Redox Biol. 2021 Jun;42:101869. doi: 10.1016/j.redox.2021.101869. Epub 2021 Jan 22.
PubMed 33541846
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nutritional Intervention Based on the Principles of Mediterranean Diet as a Putative Regulator of Craving and Redox Status of Patients Under Medication-assisted Treatment With Methadone and Buprenorphine: The Study Protocol of a Randomized Controlled Trial (the MED-DOPE Study)
- ClinicalTrials.gov ID
- NCT07022782
- Acronym / sponsor ID
- MED-DOPE / 48383/3-2-2022
- Conditions
- Opioid Addiction
- Keywords
- Mediterranean diet, Opioid use disorders, Methadone, Buprenorphine, Oxidative stress, Antioxidants, Nutrition, Craving
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Aristidis VeskoukisUniversity, hospital or other
- Collaborators
- Organization Against Drugs (OKANA)
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 18 Aug 2025 (actual)
- Study completion
- May 2026 (estimated)
- First posted
- 15 Jun 2025 (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.
The MED-DOPE (MEDiterranean diet-driven Detoxification of OPioid addicted patiEnts) study is a randomized controlled trial that aims to investigate the role of a nutritional intervention based on the principles of Mediterranean diet on craving, which is the primary outcome, and blood redox status of opioid-addicted patients under medication-assisted treatment with buprenorphine and methadone. In detail, the patients of the intervention group will consume three meals per day (i.e., breakfast, lunch and dinner) based on the principles of Mediterranean diet for 90 days. The patients of the control group will follow their normal nutritional habits. Craving as the primary outcome, quality of sleep and biochemical parameters such as blood redox status will be evaluated. It is hypothesized that the applied nutritional intervention will reduce craving, probably through the improvement of blood redox status, of the patients of the intervention group compared to the patients of the control group.
Detailed description
Background: Methadone and buprenorphine are considered as the "gold standard" medication-assisted treatment (MAT) for patients with opioid use disorders (OUDs). Patients who suffer from OUDs usually experience serious health consequences in the psychosocial and the biochemical level. Specifically, they are at 10-fold higher mortality risk than those of the general population. Moreover, there are inconsistencies related to the efficacy of MAT (i.e., methadone and buprenorphine) on retention to treatment and opioid craving, that is a major psychosocial parameter to be improved towards successful rehabilitation. Craving is a central psychosocial component for addiction characterized by a strong urge to use an illicit substance that induces addiction. It appears that although MAT partially normalizes this parameter, patients with OUDs continue to experience craving for opioids leading to drug-seeking behavior and relapse. Furthermore, opioids such as heroine induce oxidative stress, a common toxic biochemical outcome. However, this is the case also for methadone and buprenorphine, although in a lower extent compared to heroine. Therefore, opioid-addiction induced oxidative stress seems to be rather neglected and needs further attention. Oxidative stress is a result of excessive reactive oxygen species generation, which may cause protein and lipid oxidation and oxidative modification of DNA. To that end, the use of plant-derived compounds as auxiliary therapeutic approaches, in combination with methadone and buprenorphine could be a promising approach towards enhancement of the effectiveness of MAT. The biological plausibility for the adoption of such a nutritional practice relies on the fact that plant components namely polyphenols exert potent antioxidant properties against oxidative stress. It has been clearly shown that pomegranate juice is such a physical product. A nutritional approach on the basis of Mediterranean diet could also be considered as an alternative approach towards rehabilitation from addiction to opioids. Indeed, Mediterranean diet has been associated with better health outcomes. Its beneficial effects on human health have largely been attributed to the antioxidant properties of its components, mainly polyphenols.
Objectives: The MED-DOPE (MEDiterranean diet-driven Detoxification of OPioid addicted patiEnts) study aims to investigate the role of a nutritional intervention based on the principles of Mediterranean diet on craving and blood redox status of patients with OUDs under buprenorphine and methadone. This diet scheme is rich in antioxidant compounds that, along with medication (i.e., methadone and buprenorphine), could putatively act beneficially on several health parameters of the patients with OUDs.
Methods: Three meals (i.e., breakfast, lunch and dinner) will be administered daily for 90 days to patients with OUDs under methadone and buprenorphine. In two time points namely Days 1 and 90 the patients will form the heroine craving questionnaire to assess craving, which is the primary outcome of MED-DOPE study. Blood samples will also be collected from the participants in order to measure redox biomarkers (i.e., glutathione concentration, total antioxidant capacity, concentraiton of protein carbonyls, glutathione reductase activity and glutathione peroxidase activity).
Anticipated Outcome: It is hypothesized that the applied nutritional intervention will reduce craving probably through the improvement of blood redox status.
Conclusion: MED-DOPE is a hypothesis-driven and evidence-based project that proposes a nutrition-based solution for craving amelioration in patients with OUDs under MAT, potentially assisting towards their successful rehabilitation and societal reintegration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention - Nutrition | Experimental | Other: A nutritional intervention based on the principles of Mediterranean dietThe intevention group will comprise patients under medication-assisted treatment (MAT) who are active members of the therapeutic units of the Greek Organization Against Drugs (OKANA). The participants will be stratified into two subgroups, i.e., methadone maintenance treatment (MMT) and buprenorphine maintenance treatment (BMT), according to the maintenance treatment program they attend. The nutritional intervention based on the principles of Mediterranean diet will be administered to the participants of both MMT and BMT subgroups of the intervention group. The patients will consume meals three times (i.e., breakfast, lunch and dinner) per day for 90 days (i.e., three months). |
| No intervention - Control group | No intervention | –The control group will comprise patients under medication-assisted treatment (MAT) who are active members of the therapeutic units of the Greek Organization Against Drugs (OKANA). The participants will be stratified into two subgroups, i.e., methadone maintenance treatment (MMT) and buprenorphine maintenance treatment (BMT), according to the maintenance treatment program they attend. No intervention wil be applied. The patients will follow their normal nutritional habbits. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 20 years of age
- Long-term heroine or other opioid drug use
- Suffering from physical and mental dependence due to chronic opioid use
Key exclusion criteria (3 listed)
- Serious medical problems, such as infection by human immunodeficiency virus or hepatitis B virus
- Current use of anti-inflammatory medication
- Relapse to other addictive substances (i.e., opioids, methamphetamine, benzodiazepines, cannabis, tetrahydrocannabinol, amphetamine) - To rule out the use of such substances, all participants will undergo weekly urine tests during the three-month period of the trial
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 |
|---|---|---|
| A nutritional intervention based on the principles of Mediterranean dietThe patients will consume meals three times (i.e., breakfast, lunch and dinner) per day for 90 days (i.e., three months) that are based on the principles of Mediterranean diet. | Other | Intervention - Nutrition |
Primary outcome
Craving
Time frame: Changes between Day 1 (pre) and Day 90 (post) will be assessed.
The effects of the applied nutritional intervention on craving will be assessed through the Heroin Craving Questionnaire (HCQ), which is a validated self-reported instrument. It is consisted of 45 questions divided in 5 dimensions, namely desire to use heroine, intentions and planning to use heroine, anticipation of positive outcome, relief from withdrawal or dysphoria, and lack of control overuse. The score is calculated with a 7-point Likert scale ranging from 1 (i.e., strongly disagree) to 7 (i.e., strongly agree) and the higher the score, the worse the outcome. HCQ will be completed by the volunteers of both the experimental and control groups at two timepoints as follows: Before the start of the experiment (i.e., Day 1 or pre) and at the end of the experiment (i.e., day 90 or post).
6 secondary outcomes
Quality of Sleep
Time frame: Changes between Day 1 (pre) and Day 90 (post) will be assessed.
Blood GSH concentration
Time frame: Changes in GSH concentration will be compared between Day 1 (pre) and Day 90 (post).
Concentration of protein carbonyls in blood
Time frame: Changes in protein carbonyl concentration will be compared between Day 1 (pre) and Day 90 (post).
Total antioxidant capacity of blood
Time frame: Changes in TAC will be compared between Day 1 (pre) and Day 90 (post).
Activity of glutathione reductase
Time frame: Changes in glutathione reductase activity will be compared between Day 1 (pre) and Day 90 (post).
Activity of glutathione peroxidase
Time frame: Changes in glutathione peroxidase activity will be compared between Day 1 (pre) and Day 90 (post).
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 9 Apr 2026.
- Background: PubMed 21956695Veskoukis AS, Tsatsakis AM, Kouretas D. Dietary oxidative stress and antioxidant defense with an emphasis on plant extract administration. Cell Stress Chaperones. 2012 Jan;17(1):11-21. doi: 10.1007/s12192-011-0293-3. Epub 2011 Sep 30.
- Background: PubMed 39798867Leventelis C, Makri S, Ververi A, Papageorgiou K, Tentolouri A, Mountzouridi E, Tekos F, Barmpas PT, Tasoulis S, Metsios GS, Kouretas D, Veskoukis AS. Pomegranate juice ameliorates craving and oxidative stress on patients under medication for opioid addiction treatment with methadone and buprenorphine: A ranzomised controlled trial. Clin Nutr ESPEN. 2025 Apr;66:34-45. doi: 10.1016/j.clnesp.2025.01.025. Epub 2025 Jan 10.
- Background: PubMed 31093318Leventelis C, Goutzourelas N, Kortsinidou A, Spanidis Y, Toulia G, Kampitsi A, Tsitsimpikou C, Stagos D, Veskoukis AS, Kouretas D. Buprenorphine and Methadone as Opioid Maintenance Treatments for Heroin-Addicted Patients Induce Oxidative Stress in Blood. Oxid Med Cell Longev. 2019 Apr 9;2019:9417048. doi: 10.1155/2019/9417048. eCollection 2019.
- Background: PubMed 29897866Estruch R, Ros E, Salas-Salvado J, Covas MI, Corella D, Aros F, Gomez-Gracia E, Ruiz-Gutierrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pinto X, Basora J, Munoz MA, Sorli JV, Martinez JA, Fito M, Gea A, Hernan MA, Martinez-Gonzalez MA; PREDIMED Study Investigators. Primary Prevention of Cardiovascular Disease with a Mediterranean Diet Supplemented with Extra-Virgin Olive Oil or Nuts. N Engl J Med. 2018 Jun 21;378(25):e34. doi: 10.1056/NEJMoa1800389. Epub 2018 Jun 13.
- Background: PubMed 29549354Billingsley HE, Carbone S. The antioxidant potential of the Mediterranean diet in patients at high cardiovascular risk: an in-depth review of the PREDIMED. Nutr Diabetes. 2018 Mar 9;8(1):13. doi: 10.1038/s41387-018-0025-1.
- Background: PubMed 35533613Arezoomandan M, Zhiani R, Mehrzad J, Motavalizadehkakhky A, Eshrati S, Arezoomandan R. Inflammatory, oxidative stress and cognitive functions in patients under maintenance treatment with methadone or buprenorphine and healthy subjects. J Clin Neurosci. 2022 Jul;101:57-62. doi: 10.1016/j.jocn.2022.04.018. Epub 2022 May 6.
- Background: PubMed 33541846Aleksandrova K, Koelman L, Rodrigues CE. Dietary patterns and biomarkers of oxidative stress and inflammation: A systematic review of observational and intervention studies. Redox Biol. 2021 Jun;42:101869. doi: 10.1016/j.redox.2021.101869. Epub 2021 Jan 22.
- Individual participant dataSharing planned: Yes. Data obtained through this investigation will be provided, upon request respecting GDPR, to qualified researchers and clinicians with related academic interest.
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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. This study is not recruiting at the moment.
Christonikos Leventelis principal investigator
Organization Against Drugs (OKANA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A nutritional intervention based on the principles of Mediterranean diet in people with Opioid Addiction, run by Aristidis Veskoukis at 1 site in Greece.
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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2026. 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 Greece. 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Craving (time frame: Changes between Day 1 (pre) and Day 90 (post) will be assessed.). 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 NCT07022782, which also lists 7 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 9 Apr 2026.