Clinical trial NCT05861544: NUTRItion-driven Detoxification of OPioid Addicted patiEnts
Official title: Pomegranate Juice Consumption by Patients Under Medication for Addiction Treatment as a Regulator of Craving and Blood Redox Status: The Study Protocol of a Randomized Control Trial (the NUTRIDOPE Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychiatry
Keywords: Craving
Buprenorphine
Opioid use disorders
Methadone
Pomegranate juice
Redox biomarkers
Inflammation
Antioxidants
Nutrition
Lead sponsor: Organization Against Drugs (ΟΚΑΝΑ)
Sponsor class: OTHER_GOV
Collaborators: name: University of Thessaly
First posted: 2023-05-17
Enrollment: 58
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Background: Buprenorphine and methadone are considered the "gold standard" medication for addiction treatment (MAT) for patients with opioid use disorders (OUDs). However, they may cause side effects promoting craving (i.e., opioid use relapse). Therefore, the concurrent administration of natural products could be an adjunct intervention to back up opioid MAT. Pomegranate is a natural substance that contains antioxidant polyphenolic compounds, which have been associated with craving reduction. Moreover, pomegranate positively affects psychosocial parameters, such as depression and anxiety that are common feelings for patients with OUDs, probably due to its potent antioxidant and anti-inflammatory properties.

Objectives: The NUTRIDOPE (NUTRItion-driven Detoxification of OPioid addicted patiEnts) study aims to investigate the role of pomegranate juice consumption by patients with OUDs under buprenorphine and methadone on craving.

Methods: Fresh pomegranate juice will be administered for 120 days (250 ml, 7 days/week) and craving, as the primary outcome, 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.

Anticipated Results: It is hypothesized that pomegranate juice will reduce craving probably through the improvement of blood redox and inflammation status.

Conclusions: NUTRIDOPE is a hypothesis-driven, evidence-based, multifactorial project that proposes a nutrition-based solution towards craving reduction for patients with OUDs under MAT, potentially assisting towards their successful rehab and societal reintegration.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Craving
timeFrame: 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:
measure: Quality of Life (QoL)
timeFrame: Day 1; Day 60; Day 120, six months following the end of the experiment (follow-up measurement)
measure: Determination of antioxidant enzyme Catalase (CAT)
timeFrame: Day 1; Day 60; Day 120, six months following the end of the experiment (follow-up measurement)
measure: Measurement of the total antioxidant capacity (TAC) of plasma
timeFrame: Day 1; Day 60; Day 120, six months following the end of the experiment (follow-up measurement)
measure: In vitro evaluation of antioxidant and reducing properties of the administered pomegranate juice
timeFrame: Day 1
measure: Measurement of the concentration of protein carbonyls
timeFrame: Day 1; Day 60; Day 120, six months following the end of the experiment (follow-up measurement)
measure: Measurement of the concentration of thiobarbituric acid reactive substances (TBARS)
timeFrame: Day 1; Day 60; Day 120, six months following the end of the experiment (follow-up measurement)
measure: Measurement of the capacity of plasma to reduce hydroxyl radical (OH•)
timeFrame: Day 1; Day 60; Day 120, six months following the end of the experiment (follow-up measurement)
measure: Measurement of the capacity of plasma to reduce superoxide radical (O2•-)
timeFrame: Day 1; Day 60; Day 120, six months following the end of the experiment (follow-up measurement)
measure: Measurement of the reducing power
timeFrame: Day 1; Day 60; Day 120, six months following the end of the experiment (follow-up measurement)
measure: Measurement of GSH concentration
timeFrame: Day 1; Day 60; Day 120, six months following the end of the experiment (follow-up measurement)
measure: Measurement of the activity of the antioxidant enzyme superoxide dismutase (SOD)
timeFrame: Day 1; Day 60; Day 120, six months following the end of the experiment (follow-up measurement)
measure: Measurement of the activity of the antioxidant enzyme glutathione peroxidase (GPx)
timeFrame: Day 1; Day 60; Day 120, six months following the end of the experiment (follow-up measurement)
measure: Measurement of the activity of the antioxidant enzyme glutathione reductase (GR)
timeFrame: Day 1; Day 60; Day 120, six months following the end of the experiment (follow-up measurement)
measure: Measurement of the concentration of interferon gamma (IFN-γ)
timeFrame: Day 1; Day 60; Day 120, six months following the end of the experiment (follow-up measurement)
measure: Measurement of the concentration of interferon alpha-2 (IFN-a2)
timeFrame: Day 1; Day 60; Day 120, six months following the end of the experiment (follow-up measurement)
measure: Measurement of the concentration of interleukin-1 betta (IL-1b)
timeFrame: Day 1; Day 60; Day 120, six months following the end of the experiment (follow-up measurement)
measure: Measurement of the concentration of interleukin-8 (IL-8)
timeFrame: Day 1; Day 60; Day 120, six months following the end of the experiment (follow-up measurement)
measure: Measurement of the concentration of monocyte chemoattractant protein-1 (MCP-1)
timeFrame: Day 1; Day 60; Day 120, six months following the end of the experiment (follow-up measurement)
measure: Measurement of the concentration of interleukin-1 alpha (IL-1a)
timeFrame: Day 1; Day 60; Day 120, six months following the end of the experiment (follow-up measurement)
measure: Measurement of the concentration of tumor necrosis factor alpha (TNF-a)
timeFrame: Day 1; Day 60; Day 120, six months following the end of the experiment (follow-up measurement)
measure: Measurement of the concentration of melatonin
timeFrame: Day 1; Day 60; Day 120, six months following the end of the experiment (follow-up measurement)
measure: Measurement of the concentration of cortisol
timeFrame: Day 1; Day 60; Day 120, six months following the end of the experiment (follow-up measurement)
Other outcomes:
measure: Sleep evaluation
timeFrame: Day 1; Day 60; Day 120, six months following the end of the experiment (follow-up measurement)
measure: Fatigue evaluation
timeFrame: Day 1; Day 60; Day 120, six months following the end of the experiment (follow-up measurement)
measure: Mood
timeFrame: Day 1; Day 60; Day 120, six months following the end of the experiment (follow-up measurement)
measure: Evaluation of constipation
timeFrame: Day 1; Day 60; Day 120, six months following the end of the experiment (follow-up measurement)
measure: Faecal evaluation
timeFrame: Day 1; Day 60; Day 120, six months following the end of the experiment (follow-up measurement)
Locations:
city: Athens
country: Greece
facility: Organization Against Drugs
state: Attiki
Study officials:
affiliation: Organization against Drugs
name: Christonikos Leventelis, Dr
role: PRINCIPAL_INVESTIGATOR
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