Randomised controlled trial of the short-term effects of OROS-methylphenidate on ADHD symptoms and behavioural outcomes in young male prisoners with attention-deficit/hyperactivity disorder (CIAO-II)

Abstract Background: Attention-deficit/hyperactivity disorder (ADHD) is a highly prevalence disorder, seen in 20-30% of young adult prisoners. Pharmacoepidemiological studies, a small randomised controlled, and open trial data suggest clinically significant reductions in ADHD symptoms, emotional dysregulation, disruptive behaviour and engagement with educational activities. Yet, routine treatment of ADHD in offenders with ADHD is not yet established clinical practice. There is continued uncertainty about the clinical response to methylphenidate, a first line treatment for ADHD, in offenders who often present with an array of complex mental health problems that may better explain states of inattentive, overactive restless and impulsive behaviours. To address this problem we conduct an efficacy trial to establish the short term effects of OROS-methylphenidate (Concerta XL), an extended release formulation of MPH, on ADHD symptoms, emotional dysregulation and behaviour. Methods: Parallel arm randomised placebo-controlled trial of OROS-MPH on ADHD symptoms, behaviour and functional outcomes in young male prisoners aged 16-25, meeting DSM-5 criteria for ADHD. Participants are randomised to 8-weeks treatment with OROS-MPH or placebo, titrated over 5 weeks to balance ADHD symptom improvement against side effects. 200 participants will be recruited with 1:1 ratio of drug to placebo. The primary outcome is change in level of ADHD symptoms after 8-weeks of trial medication. Discussion: Potential benefits include improvement in ADHD symptoms, emotional dysregulation, attitudes towards violence, critical incidents and engagement with educational and rehabilitation programs. Demonstrating efficacy and safety of MPH on ADHD symptoms and associated impairments may provide the data needed to develop effective healthcare pathways for a significant group of young offenders. Establishing efficacy of MPH in this population will provide the foundation needed to establish long term effectiveness studies with the potential for demonstrating significant reductions in criminal behaviour and improved health-economic outcomes. Trial Registration: ISRCTN16827947l; EudraCT Number: 2015-004271-78. Protocol version: v2.0 30.08.2018