ArticleAddiction science & clinical practice2023
Subthreshold opioid use disorder prevention (STOP) trial: a cluster randomized clinical trial: study design and methods.
Article in Addiction science & clinical practice, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04218201 (Subthreshold Opioid Use Disorder Prevention), which is not on this map. Cited by 4 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Subthreshold Opioid Use Disorder Prevention (STOP) Trial
Who cites it
4 citing papers in PubMed, 5 citations in OpenAlex.
- Collaborative care intervention for risky opioid use among primary care patients: The STOP randomized clinical trial.Addiction (Abingdon, England) · 2026Trial
- Understanding the characteristics and comorbidities of primary care patients with risky opioid use: Baseline data from the multi-site "Subthreshold Opioid Use Disorder Prevention" (STOP) Trial.Journal of general internal medicine · 2025Trial
- Using explainable machine learning to elucidate social and neurobehavioral risk factors linked to nonmedicinal opioid use in young adults.Scientific reports · 2025Article
- Why is substance use missing from my patient's problem list? CTN research to advance screening, prevention, and treatment of substance use in primary care.Journal of substance use and addiction treatment · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors at 9 institutions in 1 country.
Funding
Abstract
backgroundPreventing progression to moderate or severe opioid use disorder (OUD) among people who exhibit risky opioid use behavior that does not meet criteria for treatment with opioid agonists or antagonists (subthreshold OUD) is poorly understood. The Subthreshold Opioid Use Disorder Prevention (STOP) Trial is designed to study the efficacy of a collaborative care intervention to reduce risky opioid use and to prevent progression to moderate or severe OUD in adult primary care patients with subthreshold OUD.
methodsThe STOP trial is a cluster randomized controlled trial, randomized at the PCP level, conducted in 5 distinct geographic sites. STOP tests the efficacy of the STOP intervention in comparison to enhanced usual care (EUC) in adult primary care patients with risky opioid use that does not meet criteria for moderate-severe OUD. The STOP intervention consists of (1) a practice-embedded nurse care manager (NCM) who provides patient participant education and supports primary care providers (PCPs) in engaging and monitoring patient-participants; (2) brief advice, delivered to patient participants by their PCP and/or prerecorded video message, about health risks of opioid misuse; and (3) up to 6 sessions of telephone health coaching to motivate and support behavior change. EUC consists of primary care treatment as usual, plus printed overdose prevention educational materials and an educational video on cancer screening. The primary outcome measure is self-reported number of days of risky (illicit or nonmedical) opioid use over 180 days, assessed monthly via text message using items from the Addiction Severity Index and the Current Opioid Misuse Measure. Secondary outcomes assess other substance use, mental health, quality of life, and healthcare utilization as well as PCP prescribing and monitoring behaviors. A mixed effects negative binomial model with a log link will be fit to estimate the difference in means between treatment and control groups using an intent-to-treat population. DISCUSSION: Given a growing interest in interventions for the management of patients with risky opioid use, and the need for primary care-based interventions, this study potentially offers a blueprint for a feasible and effective approach to improving outcomes in this population.
trial registrationClinicaltrials.gov, identifier NCT04218201, January 6, 2020.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.