Background: People with substance use disorders generally have unhealthy diets, including limited intake of fruitand vegetables. Evidence shows substantial health benefits from increasing fruit and vegetable consumption onvarious indicators and possibly also psychological distress. A pilot study has indicated that supplementation with fruitsmoothie could be promising also among people receiving opioid agonist therapy for opioid dependence. FruktBARwill compare the efficacy of added fruit smoothie supplementation to people receiving opioid agonist therapy comparedto standard treatment without added supplementation.Methods: FruktBAR is a multicentre, randomised controlled trial. The trial will aim to recruit 302 patients receivingopioid agonist therapy. The intervention involves daily supplementation with 250 ml fruit smoothie including a varietyof fruits such as apple, pineapple, mango, bananas, orange, blueberries, passion fruit, coconut, lime, and blackcurrant.The main endpoints are 16 weeks after intervention initiation. Participants will be included and followed up duringand after the intervention. The target group will be patients with opioid dependence receiving opioid agonist therapyfrom involved outpatient clinics in Bergen and Stavanger, two of the largest cities in Norway. The main outcomeis psychological distress assessed with Hopkins Symptom Checklist (SCL-10) at the end of the intervention period16 weeks after initiation, and will be compared between the intervention and control arms. Secondary outcomemeasures are changes in fatigue, physical functioning assessed with a 4-minute step-test, health-related quality of life,biochemical indicators of inflammation, and biochemical indicators of fruit intake.Discussion: This study will inform on the relative advantages or disadvantages of fruit supplementation in additionto the current medically and psychologically oriented treatment of people receiving opioid agonist therapy. If thesupplementation is efficacious, it can be considered for further scale-up.
