Pomegranate juice consumption by patients under medication for addiction treatment as regulator of craving and blood redox status: The study protocol of a randomized control trial (the NUTRIDOPE study)

Abstract

Abstract 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. Pomegranate is a natural substance that contains antioxidant polyphenolic compounds, which have been associated with craving reduction. Aim: The NUTRIDOPE (NUTRItion-driven Detoxification of OPioid addicted patiEnts) study aims to investigate the role of pomegranate juice consumption by opioid patients under buprenorphine and methadone on craving, as the primary outcome, and biopsychosocial parameters. Methods NUTRIDOPE is a randomized control trial with repeated measures. The participants, who will be patients with OUDs attending rehab programs in the Greek Organization Against Drugs, will be randomly divided into the experimental and the control groups and both groups will be further stratified into two subgroups, i.e., methadone and buprenorphine, according to the maintenance treatment program they attend. Pomegranate juice will be administered to the participants of the experimental group, whereas their counterparts in the control group will not consume any similar beverage. The administration regimen will be 250 ml, seven days/week, four months. Results Craving, as well as physiological (sleep, constipation, fatigue), psychosocial (depression, mood state, quality of life) and biochemical (i.e., blood redox status and inflammation) parameters will be evaluated. Conclusions NUTRIDOPE is a hypothesis-driven, evidence-based, multifactorial project that proposes a nutrition-based solution towards craving reduction for opioid patients under MAT, potentially assisting towards their successful rehab and societal reintegration. ClinicalTrials.gov Identifier: NCT05861544