Under-representation of key demographic groups in opioid use disorder trials

Rudolph, Kara E.; Russell, Matthew B.; Luo, Sean X.; Rotrosen, John; Nunes, Edward V.

doi:10.1016/j.dadr.2022.100084

Cited by 7 publications

(6 citation statements)

References 67 publications

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“…[15] There are several potential reasons for this discrepancy between trial and real-world data results. First, there are likely differences in the distribution of patient characteristics between the trial and real-world population[12] and these characteristics may increase or decrease the risk of medication discontinuation. For example, the proportion of people experiencing unstable housing may differ between trial and real-world populations and unstable housing has been shown to effect medication effectiveness.…”

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

“…Patients enrolled in clinical trials may not be representative of the real-world population of patients with OUD. [12] How treatment is delivered (e.g., intensity of follow-up, monetary incentives) also differs between trials and real-world practice. These differences in patient characteristics and treatment delivery are likely to modify treatment effectiveness.…”

Section: Introductionmentioning

confidence: 99%

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WITHDRAWN: Comparative effectiveness of extended release naltrexone and sublingual buprenorphine for treatment of opioid use disorder among Medicaid patients

Ross,

Nunes,

Olfson

et al. 2024

Preprint

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Aims: To compare the real-world effectiveness of extended release naltrexone (XR-NTX) and sublingual buprenorphine (SL-BUP) for the treatment of opioid use disorder (OUD) Design: An observational active comparator, new user cohort study Setting: Medicaid claims records for patients in New Jersey and California, 2016-2019 Participants/Cases: Adult Medicaid patients aged 18-64 years who initiated XR-NTX or SL-BUP for maintenance treatment of OUD and did not use medications for OUD in the 90-days before initiation Comparators: New initiation with XR-NTX versus SL-BUP for the treatment of OUD Measurements: We examined two outcomes up to 180 days after medication initiation, 1) composite of medication discontinuation and death, and 2) composite of overdose and death Findings: Our cohort included 1,755 XR-NTX and 9,886 SL-BUP patients. In adjusted analyses, treatment with XR-NTX was more likely to result in discontinuation or death by the end of follow-up than treatment with SL-BUP: cumulative risk 76% (95% confidence interval [CI] 75%, 78%) versus 62% (95% CI 61%, 63%), respectively (risk difference 14 percentage points, 95% CI 13, 16). There was minimal difference in the cumulative risk of overdose or death by the end of follow-up: XR-NTX 3.8% (95% CI 2.9%, 4.7%) versus SL-BUP 3.3% (95% 2.9%, 3.7%); risk difference 0.5 percentage points, 95% CI -0.5, 1.5. Results were consistent across sensitivity analyses. Conclusions: Longer medication retention is important because risks of negative outcomes are elevated after discontinuation. Our results support selection of SL-BUP over XR-NTX. However, most patients discontinued medication by 6 months indicating that more effective tools are needed to improve medication retention, particularly after initiation with XR-NTX, and to identify which patients do best on which medication.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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WITHDRAWN: Comparative effectiveness of extended release naltrexone and sublingual buprenorphine for treatment of opioid use disorder among Medicaid patients

Ross,

Nunes,

Olfson

et al. 2024

Preprint

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“…Future studies are needed in contemporary populations with prevalent use of fentanyl or other high-potency synthetic opioid agonists . As with all individual-level predictive models, there might be substantial pitfalls due to algorithmic bias, as well as issues relative to the underrepresentation of demographic groups that might affect predictive fairness . Finally, using a variety of binary outcomes derived from UDSs (eg, full abstinence, longer or shorter duration of consecutive missing or positive results) could produce a family of predictive models and benefit from a generative modeling approach.…”

Section: Discussionmentioning

confidence: 99%

“…An important limitation is that patients who sign up for a clinical trial may not be fully representative of those seeking treatment in the community. 28 In addition, the 3 data sets came from distinct patient populations, 29 and although the model results were similar across all 3, replication in other populations would be necessary to determine generalizability. The harmonizable study data covered only 12 weeks, a necessary first stage of achieving sustained abstinence.…”

Section: Strengths and Limitationsmentioning

confidence: 99%

Individual-Level Risk Prediction of Return to Use During Opioid Use Disorder Treatment

Luo,

Feaster,

Liu

et al. 2024

JAMA Psychiatry

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ImportanceNo existing model allows clinicians to predict whether patients might return to opioid use in the early stages of treatment for opioid use disorder.ObjectiveTo develop an individual-level prediction tool for risk of return to use in opioid use disorder.Design, Setting, and ParticipantsThis decision analytical model used predictive modeling with individual-level data harmonized in June 1, 2019, to October 1, 2022, from 3 multicenter, pragmatic, randomized clinical trials of at least 12 weeks’ duration within the National Institute on Drug Abuse Clinical Trials Network (CTN) performed between 2006 and 2016. The clinical trials covered a variety of treatment settings, including federally licensed treatment sites, physician practices, and inpatient treatment facilities. All 3 trials enrolled adult participants older than 18 years, with broad pragmatic inclusion and few exclusion criteria except for major medical and unstable psychiatric comorbidities.InterventionAll participants received 1 of 3 medications for opioid use disorder: methadone, buprenorphine, or extended-release naltrexone.Main Outcomes and MeasuresPredictive models were developed for return to use, which was defined as 4 consecutive weeks of urine drug screen (UDS) results either missing or positive for nonprescribed opioids by week 12 of treatment.ResultsThe overall sample included 2199 trial participants (mean [SD] age, 35.3 [10.7] years; 728 women [33.1%] and 1471 men [66.9%]). The final model based on 4 predictors at treatment entry (heroin use days, morphine- and cocaine-positive UDS results, and heroin injection in the past 30 days) yielded an area under the receiver operating characteristic curve (AUROC) of 0.67 (95% CI, 0.62-0.71). Adding UDS in the first 3 treatment weeks improved model performance (AUROC, 0.82; 95% CI, 0.78-0.85). A simplified score (CTN-0094 OUD Return-to-Use Risk Score) provided good clinical risk stratification wherein patients with weekly opioid-negative UDS results in the 3 weeks after treatment initiation had a 13% risk of return to use compared with 85% for those with 3 weeks of opioid-positive or missing UDS results (AUROC, 0.80; 95% CI, 0.76-0.84).Conclusions and RelevanceThe prediction model described in this study may be a universal risk measure for return to opioid use by treatment week 3. Interventions to prevent return to regular use should focus on this critical early treatment period.

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MOUD use among Hispanic clients increased post-ACA, yet differed by heritage and geographic location

Herrera,

Choi,

Johnson

2025

Drug and Alcohol Dependence

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Under-representation of key demographic groups in opioid use disorder trials

Cited by 7 publications

References 67 publications

WITHDRAWN: Comparative effectiveness of extended release naltrexone and sublingual buprenorphine for treatment of opioid use disorder among Medicaid patients

WITHDRAWN: Comparative effectiveness of extended release naltrexone and sublingual buprenorphine for treatment of opioid use disorder among Medicaid patients

Individual-Level Risk Prediction of Return to Use During Opioid Use Disorder Treatment

MOUD use among Hispanic clients increased post-ACA, yet differed by heritage and geographic location

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