Data cleaning and harmonization of clinical trial data: Medication-assisted treatment for opioid use disorder.

Several large-scale, pragmatic clinical trials on opioid use disorder (OUD) have been completed in the National Drug Abuse Treatment Clinical Trials Network (CTN). However, the resulting data have not been harmonized between the studies to compare the patient characteristics. This paper provides lessons learned from a large-scale harmonization process that are critical for all biomedical researchers collecting new data and those tasked with combining datasets.

Optimizing Contingency Management with Reinforcement Learning.

Contingency Management (CM) is a psychological treatment that aims to change behavior with financial incentives. In substance use disorders (SUDs), deployment of CM has been enriched by longstanding discussions around the cost-effectiveness of prized-based and voucher-based approaches. In prize-based CM, participants earn draws to win prizes, including small incentives to reduce costs, and the number of draws escalates depending on the duration of maintenance of abstinence.

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

Importance: No existing model allows clinicians to predict whether patients might return to opioid use in the early stages of treatment for opioid use disorder.

Objective: To develop an individual-level prediction tool for risk of return to use in opioid use disorder.

Design, Setting, And Participants: This 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.

Associations between stimulant use and return to illicit opioid use following initiation onto medication for opioid use disorder.

Aim: The aim of this study was to estimate how ongoing stimulant use affects return to illicit opioid use after initiation onto medication for opioid use disorder (MOUD).

Design: This was a secondary analysis of pooled data from two clinical trials comparing buprenorphine (BUP-NX) and extended-release naltrexone (XR-NTX).

Setting: Thirteen opioid treatment programs and HIV clinics across 10 states in the United States from 2014 to 2019 took part in this study.

Capturing drug use patterns at a glance: An n-ary word sufficient statistic for repeated univariate categorical values.

Introduction: The efficacy of treatments for substance use disorders (SUD) is tested in clinical trials in which participants typically provide urine samples to detect whether the person has used certain substances via urine drug screenings (UDS). UDS data form the foundation of treatment outcome assessment in the vast majority of SUD clinical trials. However, existing methods to calculate treatment outcomes are not standardized, impeding comparability between studies and prohibiting reproducibility of results.

Risks of returning to opioid use at treatment entry and early in opioid use disorder treatment: Role of non-opioid substances.

Objective: Patients in treatment with medications for opioid use disorder (MOUD) often report use of other substances in addition to opioids. Few studies exist that examine the relationship between use at treatment entry and early non-opioid use in opioid treatment outcome.

Methodology: We combined and harmonized three randomized, controlled MOUD clinical trials from the National Institutes of Drug Abuse (NIDA) Clinical Trials Network (CTN) (N=2197) and investigated the association of non-opioid substance use at treatment entry and during early treatment with a return to opioid use.

Clinical effect of endovascular repair of complex aortic lesions using optimized Octopus surgery.

Complex aortic lesions, especially those involving branches of the visceral artery, remain a challenge to treat. A single-center study using the Octopus technique to evaluate the safety and short-term effects of endovascular repair of complex aortic lesions was reported and documented. The data of six cases who underwent optimized Octopus surgery in our center from August 2020 to February 2022 were analyzed retrospectively.

Immune checkpoint inhibitors related respiratory disorders in patients with lung cancer: A meta-analysis of randomized controlled trials.

Background: In recent years, immune checkpoint inhibitors (ICIs) had extremely rapid growth in anti-cancer and improved outcomes of many malignancies, specifically lung cancer. However, the incidence of ICIs-related adverse events also raised. Using this meta-analysis, ICIs-related respiratory disorders were investigated in lung cancer patients.

Risk of Experiencing an Overdose Event for Patients Undergoing Treatment With Medication for Opioid Use Disorder.

Objective: Overdose risk during a course of treatment with medication for opioid use disorder (MOUD) has not been clearly delineated. The authors sought to address this gap by leveraging a new data set from three large pragmatic clinical trials of MOUD.

Methods: Adverse event logs, including overdose events, from the three trials (N=2,199) were harmonized, and the overall risk of having an overdose event in the 24 weeks after randomization was compared for each study arm (one methadone, one naltrexone, and three buprenorphine groups), using survival analysis with time-dependent Cox proportional hazard models.

Characteristics of the Severe Acute Respiratory Syndrome Coronavirus 2 Omicron BA.2 Subvariant in Jilin, China from March to May 2022.

Background And Objectives: In the midst of the pandemic, new coronavirus mutants continue to emerge; the most relevant variant worldwide is omicron. Here, patients who recovered from the disease living in Jilin Province were analyzed to identify factors affecting the severity of omicron infection and to provide insights into its spread and early indication.

Methods: In this study, 311 cases of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were divided into two groups.

Treatment of abdominal aortic pseudoaneurysm caused by brucellosis with endovascular aneurysm repair.

Peripheral vascular disease caused by brucellosis is rarely seen around the world; thus, it is easily ignored by patients and doctors, leading to a lack of corresponding screening and delayed comprehensive treatment. Currently, there is no standard or guideline for diagnosing and treating peripheral arterial disease caused by brucellosis. From June 2021 to December 2022, four cases of abdominal aortic pseudoaneurysm caused by brucellosis disease were treated with endovascular aneurysm repair This study reported treatment results as follows and reviewed the incidence, treatment, and prognosis of abdominal aortic pseudoaneurysm caused by brucellosis.

Specific polysubstance use patterns predict relapse among patients entering opioid use disorder treatment.

Introduction: While polysubstance use has consistently been associated with higher rates of relapse, few studies have examined subgroups with specific combinations and time course of polysubstance use (i.e., polysubstance use patterns).

Electroencephalogram pattern association with drug-related cues in a long-duration virtual reality environment in patients with methamphetamine use disorder.

The cognitive processing of drug-related cues and the subsequent dysregulation of behaviour play a central role in the pathophysiology of substance use disorders. Prior studies are limited by small sample sizes and a lack of immersion in stimulus presentation. In the present study, we recruited patients with methamphetamine use disorder (MUD; N = 1099) from four compulsory isolated detoxification centres and healthy control participants (N = 305).

Optimally Choosing Medication Type for Patients With Opioid Use Disorder.

Patients with opioid use disorder (OUD) tend to get assigned to one of 3 medications based on the treatment program to which the patient presents (e.g., opioid treatment programs tend to treat patients with methadone, while office-based practices tend to prescribe buprenorphine).

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

Background: The extent to which clinical trials of medications for opioid use disorder (MOUD) are representative or not is unknown. Some patient characteristics modify MOUD effectiveness; if these same characteristics differ in distribution between the trial population and usual-care population, this could contribute to lack of generalizability-a discrepancy between trial and usual-care effectiveness. Our objective was to identify interpretable, multidimensional subgroups who were prescribed MOUD in substance use treatment programs in the US but who were not represented or under-represented by clinical trial participants.

Efficacy of terpenoids in attenuating pulmonary edema in acute lung injury: A meta-analysis of animal studies.

The clinical efficiency of terpenoids in treating human acute lung injury (ALI) is yet to be determined. The lipopolysaccharide-induced rat model of ALI is a well-established and widely used experimental model for studying terpenoids' effects on ALI. Using a systematic review and meta-analysis, the therapeutic efficiency of terpenoid administration on the lung wet-to-dry weight ratio in rats was investigated.

Medication Use and Physical Assaults in the Psychiatric Emergency Department.

To evaluate the relationship between medications used to treat acute agitation (antipsychotics, mood stabilizers, and benzodiazepines) and subsequent assault incidence in the psychiatric emergency department. Medication orders and assault incident reports were obtained from electronic health records for 17,056 visits to an urban psychiatric emergency department from 2014 to 2019. Assault risk was modeled longitudinally using Poisson mixed-effects regression.

Optimizing opioid use disorder treatment with naltrexone or buprenorphine.

Background: Relapse rates during opioid use disorder (OUD) treatment remain unacceptably high. It is possible that optimally matching patients with medication type would reduce risk of relapse. Our objective was to learn a rule by which to assign type of medication for OUD to reduce risk of relapse, and to estimate the extent to which risk of relapse would be reduced if such a rule were used.

Open-label trial of a single-day induction onto buprenorphine extended-release injection for users of heroin and fentanyl.

Background And Objectives: Fentanyl and other highly potent synthetic opioids are the leading cause of opioid overdose deaths in the United States.

Methods: This study was an open-label, uncontrolled 12-week outpatient clinical trial to test the feasibility of a single-day induction onto extended-release buprenorphine (BXR) injection treatment for five adults (N = 5) with opioid use disorder using heroin-containing fentanyl. Participants were planned to receive three monthly BXR injections (300, 300, and 100 mg).

An open-label pilot study of pregabalin pharmacotherapy for alcohol use disorder.

: There is a need for alcohol use disorder (AUD) pharmacotherapy that can be administered to actively drinking outpatients. Pregabalin, a gabapentoid anticonvulsant, has preliminary evidence supporting effects on alcohol withdrawal and AUD.: To evaluate the safety, tolerability, and optimal dosing of pregabalin for treating AUD.

Explaining differential effects of medication for opioid use disorder using a novel approach incorporating mediating variables.

Background And Aims: A recent study found that homeless individuals with opioid use disorder (OUD) had a lower risk of relapse on extended-release naltrexone (XR-NTX) versus buprenorphine-naloxone (BUP-NX), whereas non-homeless individuals had a lower risk of relapse on BUP-NX. This secondary study examined differences in mediation pathways to medication effect between homeless and non-homeless participants.

Design: Secondary analysis of an open-label randomized controlled, 24-week comparative effectiveness trial, 2014-17.

Digital Clinical Trials for Substance Use Disorders in the Age of Covid-19.

: As a result of the coronavirus 2019 (Covid-19) pandemic, clinical research for substance use disorders (SUDs) has been impeded due to widespread stay-at-home mandates limiting the operations of "non-essential" work. Although appropriate to proceed with an abundance of caution to prevent viral spread, there will be detrimental consequences for patients with SUDs if clinical trials research cannot adapt and continue uninterrupted. The field of digital health has strong evidence for its feasibility and effectiveness and offers tools that can facilitate the continuation of SUD clinical trials research remotely in accordance with Covid-19 precautions.