NUTRItion-driven Detoxification of OPioid Addicted patiEnts

NCT05861544 | Unknown DMC

• 1 other identifier: 44482-2/12/2020
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The NUTRIDOPE (NUTRItion-driven Detoxification of OPioid addicted patiEnts) study is a clinical trial that aims to investigate the role of pomegranate juice consumption by opioid-addicted patients under buprenorphine and methadone on craving, which is the primary outcome, and other parameters. In detail, fresh pomegranate juice will be administered for 120 days (250 ml, 7 days/week) to the patients and craving as well as other psychosocial (e.g., depression, mood state, quality of life) and biochemical (i.e., blood redox status and inflammation) parameters will be evaluated. It is hypothesized that pomegranate juice will reduce craving probably through the improvement of blood redox and inflammation status. Pomegranate juice, which is the examined nutritional intervention, will be administered to the participants of the experimental group, whereas their counterparts in the control group will not consume any similar beverage as a placebo due to the objective difficulties of making one that will be identical and not separable with the fresh pomegranate juice.

Conditions

Psychiatry

Keywords

Craving; Buprenorphine; Opioid use disorders; Methadone; Pomegranate juice; Redox biomarkers; Inflammation; Antioxidants; Nutrition

Outcome Measures

Primary Outcomes (1)

• Craving

  Heroin Craving Questionnaire (HCQ), which is a validated instrument, will be used for the assessment of the effects of pomegranate juice on craving. It is consisted of 45 questions divided in 5 dimensions, namely desire to use heroin, intentions and planning to use heroin, anticipation of positive outcome, relief from withdrawal or dysphoria, and lack of control overuse. HCQ will be completed by the volunteers of both the experimental and control groups at four timepoints in order to assess the change on craving as follows: Before the start of the experiment (i.e., day 1 or baseline), in the middle of the experiment (i.e., day 60), at the end of the experiment (i.e., day 120), and 6 months after the end of the experiment (i.e., follow-up measurement).

  Changes between Day 1 (baseline) and the following time points: Day 60, Day 120, six months following the end of the experiment (follow-up measurement) will be assessed.

Secondary Outcomes (22)

• Quality of Life (QoL)

  Day 1; Day 60; Day 120, six months following the end of the experiment (follow-up measurement)

• Determination of antioxidant enzyme Catalase (CAT)

  Day 1; Day 60; Day 120, six months following the end of the experiment (follow-up measurement)

• Measurement of the total antioxidant capacity (TAC) of plasma

  Day 1; Day 60; Day 120, six months following the end of the experiment (follow-up measurement)

• In vitro evaluation of antioxidant and reducing properties of the administered pomegranate juice

  Day 1

• Measurement of the concentration of protein carbonyls

  Day 1; Day 60; Day 120, six months following the end of the experiment (follow-up measurement)

Other Outcomes (5)

• Sleep evaluation

  Day 1; Day 60; Day 120, six months following the end of the experiment (follow-up measurement)

• Fatigue evaluation

  Day 1; Day 60; Day 120, six months following the end of the experiment (follow-up measurement)

• Mood

  Day 1; Day 60; Day 120, six months following the end of the experiment (follow-up measurement)

Study Arms (2)

Experimental group

EXPERIMENTAL

Patients under medication for addiction treatment (MAT) that are active members of the Greek Organization Against Drugs (OKANA) therapeutic units will be recruited for this investigation. 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. Pomegranate juice, which is the examined nutritional intervention, will be administered to the participants of both MMT and BMT subgroups of the experimental group. The juice will be administered to the patients at the following dosage: 250 ml/day, seven days/week, for four months.

Dietary Supplement: Pomegranate juice

Control group

NO INTERVENTION

Patients under medication for addiction treatment (MAT) that are active members of the Greek Organization Against Drugs (OKANA) therapeutic units under methadone or buprenorphine treatment. 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 patients of the control group (both MMT and BMT subgroups) will not consume any similar beverage as a placebo due to the objective difficulties of making one that will be identical to the fresh pomegranate juice.

Interventions

Pomegranate juice DIETARY_SUPPLEMENT

The pomegranate juice that will be used in the experiment is a 100% natural product without conservatives. It will kindly be donated from the company Rodi Hellas SA, Pella, Greece. The product is in line with the quality assurance certificates by the International Organization for Standardization (ISO 22000:2005), Global Gap, Grasp and Kosher.

Experimental group

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 heroin 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 underwent weekly urine tests during the four-month period of the experiment

Sponsors & Collaborators

• Organization Against Drugs (ΟΚΑΝΑ): lead
• University of Thessaly: collaborator

Study Sites (1)

Organization Against Drugs

Athens, Attica, 14233, Greece

Location

Related Publications (32)

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MeSH Terms

Conditions

Opioid-Related Disorders; Inflammation

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christonikos Leventelis, Dr

  Organization against Drugs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Toxicologist, MSc, PhD

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: May 17, 2023
• Study Start: March 23, 2023
• Primary Completion: July 23, 2023
• Study Completion: January 23, 2024
• Last Updated: May 17, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data requests can be submitted starting one year after article publication and the data will be made accessible for up to 24 months.
• Access Criteria: Access to trial data can be requested by qualified researchers and will be provided following review and approval research approval.

Locations

GR (1)