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BackgroundCollaborative data sharing between research groups provides an opportunity to explore the basis for the heterogeneity in cognitive training outcomes reported in the schizophrenia literature. The current analyses focused on the contribution of site and participant characteristics to these heterogeneous outcomes.MethodsData from two independent studies, from New York (NY) and Los Angeles (LA), were combined to yield a sample of 132 outpatient adults with schizophrenia/schizoaffective disorder. While similar treatment doses, cognitive exercises and outcome measures were used, sites differed in use of coaching, group discussion and compensation. Between-site differences in participant demographic and baseline clinical characteristics were tested. Regression examined predictors of change in cognition (MCCB) and functional capacity (UPSA) which could explain site differences in treatment effects.ResultsMedium to large treatment effect size differences in MCCB and UPSA favored the NY site over LA. When the studies were combined, the effect of site was significant for both outcomes with a medium effect size difference. After controlling for background characteristics, the effect of site was reduced for both outcomes, but remained significant for cognition. Improvement in UPSA was associated with better baseline MCCB (p

Objective: To determine if treatment of co-occurring adult ADHD and Cannabis Use Disorder (CUD) with extended-release mixed amphetamine salts (MAS-ER) would be effective at improving ADHD symptoms and promoting abstinence. Method: A 12-week randomized, double-blind, two-arm pilot feasibility trial of adults with comorbid ADHD and CUD (n = 28) comparing MAS-ER (80 mg) to placebo. Main outcomes: ADHD: ≥30% symptom reduction, measured by the Adult ADHD Investigator Symptom Rating Scale (AISRS). CUD: Abstinence during last 2 observed weeks of maintenance phase. Results: Overall, medication was well-tolerated. There was no significant difference in ADHD symptom reduction (MAS-ER: 83.3%; placebo: 71.4%; p =.65) or cannabis abstinence (MAS-ER: 15.4%; placebo: 0%; p =.27). MAS-ER group showed a significant decrease in weekly cannabis use days over time compared to placebo (p <.0001). Conclusions: MAS-ER was generally well-tolerated. The small sample size precluded a determination of MAS-ER's superiority reducing ADHD symptoms or promoting abstinence. Notably, MAS-ER significantly reduced weekly days of use over time. [ABSTRACT FROM AUTHOR]

Cannabis Use Disorder (CUD) has no FDA-approved treatment. Serotonin-2c (5HT2c) agonists have preclinical and human laboratory evidence for their potential efficacy for CUD. We assessed the tolerability and effects of lorcaserin (5HT2c agonist) on CUD. In a 10-week, open label, uncontrolled trial, the tolerability of lorcaserin was tested in outpatients with CUD. Adverse events (AE) were assessed weekly. Cannabis use was assessed twice weekly by the Timeline follow-back and quantitative urine metabolites. Seventeen participants enrolled, and 14 received medication. Participants' average age was 35 years; majority were male (N = 12). The medication was well tolerated in males. There were no serious adverse events (SAE). The most common AE's were headache/migraine (N = 4, all females), anorexia (N = 3), and irritability (N = 2). Participants decreased their frequency of cannabis use significantly (p < 0.001), adjusted for baseline use. By the end of the trial, participants decreased by 1.76 (SE = 0.47) cannabis using days/week. Average daily amount of cannabis and urine THC metabolite levels did not change significantly. Lorcaserin was well tolerated in males but not females, suggesting possible sex differences. Future trials of other 5HT2c agonists (lorcaserin was withdrawn at the request of the FDA) should consider longer dose titration phases. [ABSTRACT FROM AUTHOR]

The U.S. Centers for Disease Control and Prevention (CDC) Diffusion of Effective Behavioral Interventions project has disseminated HIV behavioral interventions (EBIs) across the United States since the 1990s. In 2011, the CDC launched the High-Impact HIV Prevention (HIP) project, providing EBIs plus high-impact services (HIV testing, primary care, and support services). Providers (nurses, social workers, educators) are unable to consistently make linkages; thus, numerous at-risk individuals are not benefitting from HIP. Research on providers' roles in the HIV Continuum of Care--linking clients to HIV testing, primary care, and support services--is lacking. This article helps fill this gap with evidence that providers exposed to EBIs, whose agencies offer EBIs, more frequently link clients to high-impact services. This is based on diffusion of innovations theory, where individuals in social networks influence one another's adoption of innovations. We hypothesize that providers are exposed to EBIs via training, reading and hearing about EBIs, and/or discussing EBIs with colleagues. We used cross-sectional data from 379 providers from 36 agencies in New York City. We used multilevel ordinal logistic regression models to test associations between provider exposure to EBIs (agency provides EBIs) and frequency of linkages to high-impact services. Providers exposed to greater numbers of EBIs more frequently link clients to HIV, hepatitis C (HEP-C), and sexually transmitted infections testing; to primary care; and to drug treatment and mental health services. Providers link clients most frequently to primary care and HIV testing and least frequently to HEP-C testing and syringe exchange. Findings suggest a dose effect, with exposure to more EBIs resulting in more linkages. Findings show a staged, evidence-based prevention approach that includes exposure to EBIs, leading to providers linking clients to high-impact services. There needs to be emphasis on inspiring providers to engage with high-impact services at the elevated levels needed to end the epidemic.

Introduction/Background Tralokinumab is a high-affinity monoclonal antibody that specifically targets IL-13, a driver of inflammation in atopic dermatitis (AD). The ECZTRA 1, 2, 3, and 6 trials demonstrated that tralokinumab is efficacious and safe in adults and adolescents; however, real-world evidence on tralokinumab use is limited. Objectives To assess the change from baseline in clinician-assessed and patient-reported outcomes (PROs) among US adults with AD following 6 months of persistent tralokinumab use after treatment initiation in the CorEvitas AD registry. Methods The CorEvitas AD Registry is a prospective, non-interventional registry launched in July 2020 for adult AD patients under the care of a licensed dermatologist or qualified dermatology practitioner. This analysis includes US patients enrolled in the CorEvitas AD registry who initiated tralokinumab between February 1, 2022 and May 31, 2023, had baseline data, and were persistent on tralokinumab at the 6-month follow-up (defined as a visit occurring 5 to 9 months from tralokinumab initiation). Baseline data were summarized using descriptive statistics and stratified by advanced systemic therapy (AST) experience (defined as any previous history of dupilumab, abrocitinib, or upadacitinib). Outcome measures collected included: validated Investigator's Global Assessment for atopic dermatitis (vIGA-ADTM), ≥50%/≥75% improvement in Eczema Area and Severity Index (EASI) (EASI-50/75), ≥4-point improvement in Dermatology Life Quality Index (DLQI), ≥3-point improvement in mean weekly pruritis numerical rating scale, and mean change in Work Productivity and Activity Impairment (WPAI). Results Among the 60 patients in this analysis, the mean age was 49.1 years and mean AD duration was 15.0 years. The majority of patients were female (34/60, 56.7%), White (51/60, 85.0%), worked full-time (38/60, 63.3%), and AST-naïve (44/60, 73.3%). At baseline, the majority of patients had moderate-to-severe AD based on EASI (EASI≥ 7, 40/60, 67%) and vIGA-ADTM (vIGA-ADTM 3: 50/60, 83.3%; vIGA-ADTM 4: 4/60, 6.7%). Disease severity was lower in AST-experienced patients, all of whom were dupilumab-experienced. A notable proportion of patients experienced improvements in clinician-assessed endpoints and PROs from baseline to 6 months: vIGA-ADTM ≤1 from 6.7% (4/60) to 55.0% (33/60), EASI ≤7 from 33.3% (20/60) to 85.0% (51/60), and DLQI ≤5 from 38.3% (23/60) to 66.7% (40/60). Among patients with EASI ≥7.1 at baseline, 85.0% (34/40) achieved EASI-50 (AST-naïve: 90.9%, 30/33; AST-experienced: 57.1%, 4/7) and 77.5% (31/40) achieved EASI-75 (AST-naïve: 84.8%, 28/33; AST-experienced: 42.9%, 3/7) at the 6-month follow-up. In patients with vIGA-ADTM of 3 or 4 at baseline, 79.6% (43/54) achieved EASI-50 (AST-naïve: 83.3%, 35/42; AST-experienced: 66.7%, 8/12) and 66.7% (36/54) achieved EASI-75 (AST-naïve: 76.2%, 32/42; AST-experienced: 33.3%, 4/12) at follow-up. Among patients with baseline DLQI ≥4, 71.4% (30/42) achieved ≥4-point improvement at follow-up (AST-naïve: 78.1%, 25/32; AST-experienced: 50.0%, 5/10). Of patients with baseline mean weekly pruritus NRS ≥3, 69.8% (37/53) achieved ≥3-point improvement at follow-up (AST-naïve: 70.0%, 28/40; AST-experienced: 69.2%, 9/13). Among the 40 patients employed at both baseline and follow-up visit, improvements were reported in WPAI. Percent impairment at work due to AD decreased by 14.8% (95% CI: -25.6%; -3.9%) and percent overall work impairment due to AD decreased by 15.7% (95% CI: -26.4%; -5.0%). For all 60 patients, non-work activity impairment due to AD decreased by 14.5% (95% CI: -23.9%; -5.1%). Conclusions In this real-world study, patients with AD experienced notable improvements in both clinician-assessed and patient-reported outcomes after 6-months of persistent tralokinumab treatment, regardless of prior AST therapy use. All 16 AST-experienced patients had prior use of dupilumab. These findings support the therapeutic potential of tralokinumab for AD patients, highlighting the need for future studies with longer follow-up period and larger sample size. [ABSTRACT FROM AUTHOR]

Introduction/Background Tralokinumab is a high-affinity monoclonal antibody that specifically targets interleukin (IL)-13, a key driver of atopic dermatitis (AD). In clinical trials, tralokinumab demonstrated efficacy and a favorable safety profile for the treatment of moderate-to-severe AD in adults and adolescents. However, data on patients in the real-world setting and persistence to treatment is currently limited. Objectives To describe the baseline characteristics and persistence at 6 months of treatment in US adult patients with AD initiating tralokinumab in the CorEvitas AD registry. Methods The CorEvitas Atopic Dermatitis Registry is a prospective, non-interventional registry launched in July 2020 for adult AD patients under the care of a licensed dermatologist or qualified dermatology practitioner. Data are collected from both patients and providers approximately every 6 months during routine clinical encounters. This analysis included U.S. patients enrolled in the CorEvitas AD registry who initiated tralokinumab between February 1, 2022 (the commercial launch date) and May 31, 2023 and had baseline data. Baseline demographics and clinical characteristics were summarized using descriptive statistics and stratified by advanced systemic therapy (AST) experience, defined as any previous history of dupilumab, abrocitinib, or upadacitinib for AD treatment. A 6-month follow-up visit was defined as a visit occurring 5 to 9 months following tralokinumab initiation. Results Among 259 included patients in this study the mean age was 50.8 years. The majority of patients were female (156/259, 60.2%), White (202/259, 78.0%), worked full-time (143/259, 55.2%), had private health insurance (201/259, 77.6%), and were concomitantly on topical therapy (203/259, 78.4%). Most patients had moderate-to-severe disease, with mean Eczema Area and Severity Index (EASI) of 14.2. Approximately half of patients reported AD involvement of head (face: 121/259, 46.7%; scalp: 80/259, 30.9%; neck: 93/259, 35.9%) and hands (dorsal: 150/259, 57.9%; palmar: 130/259, 50.2%). Patients reported high symptomatic disease burden, demonstrated by mean peak pruritus in past 24 hours numerical rating scale (NRS) of 6.2, and moderate impact on quality of life, as demonstrated by mean Dermatology Life Quality Index (DLQI) of 9.8. At tralokinumab initiation, 87 patients (33.6%) were AST-experienced, of whom 95.4% (83/87) had used dupilumab. Among AST-naïve patients, 80.8% (139/172) had used super potent topical steroids, 36.0% (62/172) topical calcineurin inhibitors, and 10.5% (18/172) topical PDE4 inhibitors. Overall, socio-demographic characteristics were similar between AST-naïve and AST-experienced groups, while AST-naïve patients had higher disease severity at initiation, including mean BSA (29.4% vs. 16.9%) and mean EASI (16.9 vs. 8.8). Among patients with a 6-month follow-up visit (n=81), 74.1% (60/81) remained persistent on tralokinumab. Baseline characteristics of patients with 6-month follow-up, and of persistent patients, were similar to the total population. Among persistent patients, 73.3% (44/60) were AST-Naïve and 26.7% (16/60) were AST-experienced, all of whom were dupilumab-experienced. Mean EASI among persistent patients improved from 13.8 at baseline to 3.3 at 6 months. Of the 21 patients who discontinued tralokinumab, 52.4% (11/21) were AST-experienced at initiation, and 42.9% (9/21) switched to another systemic therapy following tralokinumab. Reasons for discontinuation included lack of efficacy (AST-naïve: 30.0%, 3/10; AST-experienced: 45.5%, 5/11), safety (AST-naïve: 30.0%, 3/10; AST-experienced: 9.1%, 1/11), insurance (AST-naïve: 10.0%, 1/10; AST-experienced: 9.1%, 1/11), and other (AST-naïve: 30.0%, 3/10; AST-experienced: 36.4%, 4/11). Conclusions In this US real-world study, adult AD patients initiating tralokinumab were both AST-naïve and AST-experienced with a high burden of disease. Approximately three-quarters of patients were persistent with tralokinumab treatment at 6 months. Further real-world evidence studies on tralokinumab persistence with longer follow-up period are warranted. [ABSTRACT FROM AUTHOR]

Background and Aims: Fentanyl is a highly lipophilic mu opioid receptor agonist, increasingly found in heroin and other drug supplies, that is contributing to marked increases in opioid‐related overdose and may be complicating treatment of opioid use disorder (OUD). This study aimed to measure the influence of body mass index (BMI) on fentanyl withdrawal and clearance. Design, Setting, Participants: This secondary analysis, from a 10‐day inpatient study on the safety and efficacy of sublingual dexmedetomidine for opioid withdrawal, includes participants with OUD (n = 150) recruited from three sites in New York, New Jersey and Florida, who were maintained on oral morphine (30 mg four times per day) for 5 days before starting study medication. Most participants (n = 118) tested positive for fentanyl on admission to the inpatient unit. Measurements: Urine toxicology and opioid withdrawal symptoms [Clinical Opioid Withdrawal Scale (COWS) and Short Opiate Withdrawal Scale (SOWS)] were assessed daily. The present analysis includes data on opioid withdrawal from days 1–5 of stabilization and urine toxicology data from days 1–10. Findings Fentanyl status at admission was not significantly associated with COWS or SOWS scores after adjusting for sex, site and polysubstance use. Participants classified as overweight or obese (n = 66) had significantly higher odds of testing positive for fentanyl across days 1–10 [odds ratio (OR) = 1.65; P < 0.01] and higher SOWS maximum scores across morphine stabilization (P < 0.05) compared to those with a healthy BMI (n = 68). Conclusions: Among inpatients with opioid use disorder, fentanyl status does not appear to be statistically significantly associated with Clinical Opioid Withdrawal Scale and Short Opiate Withdrawal Scale mean and maximum scores. High body mass index status (overweight or obese) appears to be an important predictor of slower fentanyl clearance and higher Short Opiate Withdrawal Scale maximum scores across the inpatient period than lower body mass index status. [ABSTRACT FROM AUTHOR]

The first steps of the HIV care continuum include patients finding access to HIV testing and primary care. Psychosocial providers ("providers"), such as social workers, health educators, and outreach workers comprise a workforce tasked with linking patients to HIV testing and primary care. This study examines longitudinal associations between provider- and organization-level factors and linkage to HIV testing and primary care. The sample included 245 providers in 36 agencies in New York City. We used longitudinal data (baseline and 12- and 24-months follow-ups) and multilevel ordinal logistic regression to examine associations between factors distributed in three theoretical socioecological domains: individual (demographic and HIV training characteristics); relationship (interprofessional collaboration); and agency (size and capacity), and frequency of HIV testing and primary care linkages. Approximately 30% of providers linked 20 or more patients to HIV testing or HIV primary care in the previous six months. Providers' higher endorsement of interprofessional collaboration at 12 months, formal HIV training, younger age, and Latinx ethnicity had higher odds of making more linkages to HIV testing and HIV primary care at 24 months. Training providers in interprofessional collaboration principles and practice and basic HIV knowledge may improve the frequency of linkages to HIV care continuum services. [ABSTRACT FROM AUTHOR]

Couple-based interventions may play a key role in ending the AIDS epidemic. Progress has been made in demonstrating successful implementation of both manual-based and web-based modalities of couple-based HIV prevention in clinical trials. To ensure real world implementation, however, we need a better understanding of how best to prepare organizations to support such interventions. We sought to examine which domains of staff-reported organizational readiness predicted providers' intention to deliver a couple-based HIV-prevention intervention. Organizational readiness was assessed at baseline from 253 facilitators enrolled in a randomized clinical trial testing dissemination and implementation of a couple-based HIV prevention program (2007–2012). Consistent with current organizational-readiness theory, we measured general capacities; capacities specific to a couple-based intervention; and staff motivation to implement the intervention. We used multilevel regression models to examine the influence of these capacities on intention to implement at 6-, 12-, and 18-month follow-up, adjusting for staff age, education, role, years of service, and randomized condition. Higher perceived organizational resources (B = 0.126, p =.028) and better staff motivation (B = 0.510, p =.009) were significant predictors of increased intention to facilitate Connect. Higher organizational resource availability and stronger motivation to facilitate the intervention are key domains that could inform administrator and staff training to strengthen readiness for couple-based programs. However, further research is needed to clarify the role of these domains regarding actual implementation. [ABSTRACT FROM AUTHOR]