Effectiveness of adjunctive, personalised psychosocial intervention for non-response to opioid agonist treatment: Study protocol for a pragmatic randomised controlled trial
Date
2017
Authors
Marsden, J.
Stillwell, G.
Hellier, J.
Brown, A.M.
Byford, S.
Kelleher, M.
Kelly, J.
Murphy, C.
Shearer, J.
Mitcheson, L.
Editors
Advisors
Journal Title
Journal ISSN
Volume Title
Type:
Journal article
Citation
Contemporary Clinical Trials, 2017; 53:36-43
Statement of Responsibility
John Marsden, Garry Stillwell, Jennifer Hellier, Anne Marie Brown, Sarah Byford, Michael Kelleher, Joanne Kelly, Caroline Murphy, James Shearer, Luke Mitcheson
Conference Name
Abstract
Introduction: 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 subpopulation, 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. Methods: 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 28 days prior to the endpoint). Secondary outcomes include: percentage of days abstinent from heroin and cocaine in the 28 days before follow-up; treatment retention; therapy compliance; health and social functioning; exploratory genetic biomarkers; and analyses of treatment moderation and mediation. Conclusions: 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.
School/Discipline
Dissertation Note
Provenance
Description
Access Status
Rights
© 2016 Elsevier Inc. All rights reserved.