title: Effectiveness of adjunctive, personalised psychosocial intervention for non-response to opioid agonist treatment: Study protocol for a pragmatic randomised controlled trial.
abstract: Opioid use disorder (OUD) is a debilitating and relapsing psychiatric disorder; opioid agonist therapy (OAT) is the front-line, evidence-supported treatment. A substantial number of patients relapse or continue to use heroin or other illicit drugs during OAT. There is considerable heterogeneity in the OAT-resistant sub-population, with many behavioural moderators of treatment response. We have developed a personalised psychosocial intervention (PSI) targeting these individuals. A formulation-guided assessment is linked to a toolkit of motivational, cognitive/behavioural and social support techniques. Change methods have been adapted from evidence-supported psychological therapies and are idiosyncratically tailored to the need and response.
  
  
  
  In this single-centre, 18-week, parallel group, pragmatic randomised clinical trial, we will determine the clinical and cost-effectiveness of the PSI as an adjunctive intervention during OAT, in comparison to opioid agonist treatment-as-usual. We plan to recruit 368 adults. The primary outcome measure is the proportion of participants categorised as 'responders' at the end of the intervention (defined as self-reported abstinence from heroin and cocaine with no positive biological drug tests during the 28days prior to the endpoint). Secondary outcomes include: percentage of days abstinent from heroin and cocaine in the 28days before follow-up; treatment retention; therapy compliance; health and social functioning; exploratory genetic biomarkers; and analyses of treatment moderation and mediation.
  
  
  
  This pragmatic controlled trial determines the effectiveness and cost-effectiveness of a personalised PSI for non-responding patients during OAT. Our intervention applies motivational, cognitive/behavioural and social support techniques adapted from evidence-based therapies. Findings will inform stratified delivery of OAT.
authors.affiliation: Addictions Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, United Kingdom; Lambeth Addictions, South London and Maudsley NHS Mental Health Foundation Trust, United Kingdom. Electronic address: john.marsden@kcl.ac.uk.
authors.forename: John
authors.initials: J
authors.lastname: Marsden
authors.affiliation: Addictions Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, United Kingdom; Lambeth Addictions, South London and Maudsley NHS Mental Health Foundation Trust, United Kingdom.
authors.forename: Garry
authors.initials: G
authors.lastname: Stillwell
authors.affiliation: Department of Biostatistics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, United Kingdom.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Hellier
authors.affiliation: Addictions Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, United Kingdom; Lambeth Addictions, South London and Maudsley NHS Mental Health Foundation Trust, United Kingdom.
authors.forename: Anne Marie
authors.initials: AM
authors.lastname: Brown
authors.affiliation: King's Health Economics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, United Kingdom.
authors.forename: Sarah
authors.initials: S
authors.lastname: Byford
authors.affiliation: Lambeth Addictions, South London and Maudsley NHS Mental Health Foundation Trust, United Kingdom.
authors.forename: Michael
authors.initials: M
authors.lastname: Kelleher
authors.affiliation: King's Clinical Trials Unit at King's Health Partners, Institute of Psychiatry, Psychology and Neuroscience, King's College London, United Kingdom.
authors.forename: Joanne
authors.initials: J
authors.lastname: Kelly
authors.affiliation: King's Clinical Trials Unit at King's Health Partners, Institute of Psychiatry, Psychology and Neuroscience, King's College London, United Kingdom.
authors.forename: Caroline
authors.initials: C
authors.lastname: Murphy
authors.affiliation: King's Health Economics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, United Kingdom.
authors.forename: James
authors.initials: J
authors.lastname: Shearer
authors.affiliation: Lambeth Addictions, South London and Maudsley NHS Mental Health Foundation Trust, United Kingdom.
authors.forename: Luke
authors.initials: L
authors.lastname: Mitcheson
mesh_terms: D000223:Adaptation, Psychological; D000701:Analgesics, Opioid / Q000627:therapeutic use*; D002047:Buprenorphine / Q000627:therapeutic use; D000069479:Buprenorphine, Naloxone Drug Combination / Q000627:therapeutic use; D015928:Cognitive Behavioral Therapy; D003131:Combined Modality Therapy; D006801:Humans; D008691:Methadone / Q000627:therapeutic use; D009042:Motivation; D058850:Opiate Substitution Treatment / Q000379:methods*; D009293:Opioid-Related Disorders / Q000628:therapy*; D012944:Social Support; D006113:United Kingdom
chemical_list: D000701:Analgesics, Opioid; D000069479:Buprenorphine, Naloxone Drug Combination; D002047:Buprenorphine; D008691:Methadone
keywords: Cocaine; Heroin; Opioid substitution; Psychosocial; Trial