Subthreshold opioid use disorder prevention (STOP) trial: a cluster randomized clinical trial: study design and
Jane M Liebschutz1, Geetha A Subramaniam2, Rebecca Stone3
1Division of General Internal Medicine, Center for Research On Health Care, University of Pittsburgh, 200 Lothrop Street, Suite 933W, Pittsburgh, PA, 15213, USA. liebschutzjm@upmc.edu.
Addiction Science & Clinical Practice
|November 19, 2023
Summary
The Subthreshold Opioid Use Disorder Prevention (STOP) Trial tested a collaborative care intervention to reduce risky opioid use in primary care. This approach aims to prevent progression to moderate or severe opioid use disorder (OUD).
Area of Science:
- Public Health
- Clinical Intervention Research
- Substance Use Disorders
Background:
- Preventing progression to moderate or severe opioid use disorder (OUD) in individuals with subthreshold OUD is poorly understood.
- Risky opioid use without meeting current treatment criteria requires effective primary care-based interventions.
- The Subthreshold Opioid Use Disorder Prevention (STOP) Trial addresses this knowledge gap.
Purpose of the Study:
- To evaluate the efficacy of a collaborative care intervention for adult primary care patients with subthreshold OUD.
- To reduce risky opioid use and prevent the progression to moderate or severe OUD.
- To provide a potential blueprint for feasible and effective primary care interventions.
Main Methods:
- Cluster randomized controlled trial (RCT) across 5 geographic sites, randomized at the primary care provider (PCP) level.
- Intervention group received a practice-embedded nurse care manager, brief advice, and telephone health coaching.
- Primary outcome: self-reported days of risky opioid use over 180 days; assessed monthly via text message.
Main Results:
- The study is designed to estimate the difference in means between the intervention and control groups.
- Secondary outcomes include other substance use, mental health, quality of life, and healthcare utilization.
- PCP prescribing and monitoring behaviors are also assessed as secondary outcomes.
Conclusions:
- The STOP trial's findings will inform the development of interventions for managing patients with risky opioid use.
- This study may offer a feasible and effective approach for primary care settings.
- Effective management of subthreshold OUD is crucial for preventing more severe substance use disorders.
Keywords:
Cluster-Randomized controlled trialCollaborative CareOpioid use disorderPreventionPrimary CareRisky Opioid UseSubstance use disorderMore Related Videos
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