MEDiterranean Diet-driven Detoxification of OPioid Addicted patiEnts (MED-DOPE)

NCT07022782 | Active Not Recruiting DMC

• 1 other identifier: 48383/3-2-2022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Opioid Addiction

Keywords

Mediterranean diet; Opioid use disorders; Methadone; Buprenorphine; Oxidative stress; Antioxidants; Nutrition; Craving

Outcome Measures

Primary Outcomes (1)

• 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).

  Changes between Day 1 (pre) and Day 90 (post) will be assessed.

Secondary Outcomes (6)

• Quality of Sleep

  Changes between Day 1 (pre) and Day 90 (post) will be assessed.

• Blood GSH concentration

  Changes in GSH concentration will be compared between Day 1 (pre) and Day 90 (post).

• Concentration of protein carbonyls in blood

  Changes in protein carbonyl concentration will be compared between Day 1 (pre) and Day 90 (post).

• Total antioxidant capacity of blood

  Changes in TAC will be compared between Day 1 (pre) and Day 90 (post).

• Activity of glutathione reductase

  Changes in glutathione reductase activity will be compared between Day 1 (pre) and Day 90 (post).

Study Arms (2)

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).

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.

Interventions

A nutritional intervention based on the principles of Mediterranean diet OTHER

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.

Intervention - Nutrition

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 20 years of age
• Long-term heroine or other opioid drug use
• Suffering from physical and mental dependence due to chronic opioid use

You may not qualify if:

• 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

Sponsors & Collaborators

• Aristidis Veskoukis: lead
• Organization Against Drugs (OKANA): collaborator

Study Sites (1)

Organization Against Drugs (OKANA)

Athens, Greece

Location

Related Publications (7)

• 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.

  PMID: 21956695 BACKGROUND

• Leventelis 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.

  PMID: 39798867 BACKGROUND

• Leventelis 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.

  PMID: 31093318 BACKGROUND

• Estruch 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.

  PMID: 29897866 BACKGROUND

• Billingsley 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.

  PMID: 29549354 BACKGROUND

• Arezoomandan 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.

  PMID: 35533613 BACKGROUND

• Aleksandrova 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.

  PMID: 33541846 BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Christonikos Leventelis

  Organization Against Drugs (OKANA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 7, 2025
• First Posted: June 15, 2025
• Study Start: March 10, 2025
• Primary Completion: August 18, 2025
• Study Completion: May 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

GR (1)