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The development of medications for the treatment of nicotine dependence in patients with schizophrenia is a public health priority due to its high prevalence rates, devastating medical consequences, and difficulty to treat. It has been hypothesized that the high prevalence of nicotine dependence among patients with schizophrenia may be due to a shared neurobiological vulnerability. This shared vulnerability has been evidenced in reports showing that nicotine improves neuropsychological deficits associated with schizophrenia such as in the P50 evoked auditory potentials, spatial working memory, and attention. The common pathophysiologic pathways of smoking and schizophrenia may serve as the basis for the pharmacological evaluation of medications for the treatment of these concurrent disorders. Currently, little research of medications for the treatment of this comorbidity has been conducted. Studies have evaluated the efficacy of smoking cessation medications in patients with schizophrenia. These include the nicotine replacement therapy (patch, nasal spray) and sustained release bupropion. Others have evaluated the anti-smoking effect of medications (e.g., clozapine, haloperidol) used for the treatment of schizophrenia. In both cases, the results have not been conclusive. Newer smoking cessation approaches such as varenicline, selegiline, rimonabant, and nicotine vaccine, among others, have yet to be tested in this population. The purpose of this article is to review the results of the studies conducted to date and propose some potential pharmacotherapies based on the current knowledge of the pathophysiology of both disorders. [ABSTRACT FROM AUTHOR]

This article examines the effect of target, perceiver, and relationship characteristics on the perceiver's assessment that the target may be HIV seropositive (HIV+). A sample of 267 persons was recruited from low income, high drug use neighborhoods. Respondents (perceivers) were asked to name people (targets) with whom they had a social, drug sharing, or sexual relationship. Perceivers described 1,640 such relationships. Perceivers were asked about the targets' age, gender, and race/ethnicity, whether the targets were good-looking, their level of trust with the target, and how long they had known them. Perceivers were then asked to evaluate the chances that the target mentioned was HIV+. Two regression models were estimated on the 1,640 relationships mentioned. Model 1 included variables reflecting only target characteristics as independent variables. Model 2 included variables reflecting target characteristics as well as variables reflecting perceivers and perceiver-target relationship characteristics. The results showed that targets that were female, younger, and good-looking were perceived as being less likely to be HIV+. However, when accounting for perceiver and relationship effects, some of the target characteristic effects disappeared. ((c) 2006 APA, all rights reserved). [ABSTRACT FROM AUTHOR]

The purpose of this study is to examine the potential effectiveness of Temporary Aid to Needy Families (TANF) in achieving the goals of self-sufficiency through 'work first' initiatives. A sample of 252 female TANF recipients was interviewed every 4 months for 1 year. Cluster analysis was used to group recipients by critical labor market variables including education, knowledge, skills, abilities (KSAs), and substance abuse. Results revealed 2 groups of recipients, 1 with significantly higher levels of education and KSAs and lower levels of substance use. The cluster with less desirable employment qualifications exhibited significantly lower employment levels. 'Work first' is a successful strategy for some recipients, but for many it is an unrealistic goal. Other strategies must be developed to address the many problems that a significant portion of recipients experience. [ABSTRACT FROM AUTHOR]

Co-occurrence of drug use and psychological disorders is prevalent in both clinical and population-based samples. Severity of drug use, including injection drug use, polydrug use, and frequency of drug use, may have negative consequences for psychological treatment outcomes. The current research examines the psychological functioning of 224 out-of-treatment drug users and demographically matched nonusers using the Brief Symptom Inventory (BSI). Results indicate that drug users are more psychologically impaired than nonusers on all 9 dimensions of the BSI. Comparisons of injectors to noninjectors and polydrug users to single-drug users reveal few differences. However, in examining the frequency of drug use, chronic drug users score higher on 7 of the 9 BSI dimensions. Our findings imply injection and polydrug use do not have as much effect on psychological functioning as compared with frequency of drug use. [ABSTRACT FROM AUTHOR]

The present study examined the independent effects of work-activity-participation status (whether a welfare recipient is required to work or is exempt from such requirements) on employment, receipt of cash welfare benefits known as Temporary Assistance for Needy Families (TANF), and psychological functioning. The sample consisted of 228 female TANF recipients, 75 of whom were chronic drug users. Participants were administered self-report instruments to measure self-perceived work skills and barriers to employment, drug use, employment-related variables, TANF receipt, and psychological functioning. Contrary to the tested study hypotheses, results show that the work mandate was not significantly related to employment and was positively related to TANF receipt. The work mandate showed no effect on psychological distress. Aside from initial psychological functioning, self-perceived employment barriers had the only significant impact on change in psychological functioning. Self-perceived office skills was a significant predictor of higher wages earned and less time to employment. It is concluded that training recipient in office skills training while continuing to address other barriers may be the best approach to accomplishing the goals of welfare reform. [ABSTRACT FROM AUTHOR]

Background: To present four treatment models and evaluate their effectiveness in reducing HIV risk for high-risk patients. Methods: Four models are described: 1) Traditional Medical Practice Model; 2) Physician Management Model; 3) Integrated Provider-Patient Management Model; and 4) Integrated Network Treatment Model. Data from a study of 168 drug user and nonuser social networks are used to simulate the effects of each practice model on HIV transmission and seroconversion. Survey respondents described sexual and injection risk behaviors and partners for the last 30 days. An HIV risk index was computed for each individual, combining reported risk behaviors, HIV prevalence rates for partners and HIV transmission probabilities for each risk behavior. To evaluate the 4 models, 1 person from each network was selected as a 'patient' and a simulation was performed to estimate the number of network members who would seroconvert to HIV over a 10-year period as affected by prevention efforts within each model. Results: The simulation projected that 99.7 persons in the social networks studied would seroconvert over 10 years without any intervention. The Integrated Network Treatment Model produced the greatest reduction in risk, producing 12.6 fewer sero-conversions over 10 years. Conclusions: The greater the patient involvement in prevention-oriented interventions, the greater the effect. The most pronounced effect occurs when a patient's unique social network is included in the prevention effort. [ABSTRACT FROM AUTHOR]

This article examines the factors affecting the help-seeking behavior for HIV-related social services among a sample of HIV+ urban poor individuals. In particular, the article examines how financial transfers from friends and family affect the decision to seek HIV social services from public and community organizations. The effect of transfers on the help-seeking behavior is examined while controlling for sociodemographic factors, Acquired Immunodeficiency Syndrome (AIDS) status, and HIV-transmission mode. The determinants of help-seeking behavior were estimated by conducting nine logistic regressions on a sample of 501 HIV+ individuals. The results showed that financial transfers from friends and family had a negative effect on individual's help-seeking behavior for social HIV-services, especially for supportive services. The results also showed that sociodemographic factors and HIV-transmission mode were significant determinants in the help-seeking behavior for HIV-services. [ABSTRACT FROM AUTHOR]

OBJECTIVE: This paper examines whether or not topography is a contextual variable that indirectly influences the transmission of infectious diseases. Age, gender, race/ethnicity, education level, economic status, injection drug use, and high-risk sexual behavior are known to influence infectious diseases transmission, but the effects of topography are often overlooked. DESIGN: A sample of 395 drug users were chosen from census tracts based upon a target profile of drug use behavior and demographics for the city of Houston. HIV was chosen as the infectious disease used to test this hypothesis. SETTING: Residents of 16 census tracts in Houston, Texas participated in this study. RESULTS: The findings revealed that census tracts that were 'isolated' by topographic barriers, such as bayous, parks, railroad tracks, railway yards, major thoroughfares, freeways, and unique street grids had fewer cases of HIV than census tracks that were more accessible to thru-traffic. CONCLUSION: The research findings suggest that future research studies should consider topography as being contextually related to infectious disease transmission. [ABSTRACT FROM AUTHOR]

Anecdotal accounts suggest that residency requirements often lead to denial of services at a time when HIV positive migrators are most in need of these services. However, this suspicion has never been empirically tested. Using needs assessment data collected for Harris County, Texas, this article examines eligibility and knowledge barriers faced by HIV positive recent migrators into Harris County. Results indicated that migration into the county was a significant predictor of failure to receive government-administered basic services such as food services but was not a significant predictor of failure to receive community based organization (CBO)-administered 'specialized' services targeted specifically to HIV positive individuals. Results also indicated that migration was associated with knowledge barriers for all types of services. [ABSTRACT FROM AUTHOR]

The level of sexual risk among crack cocaine uses had remained high, regardless of their level of AIDS knowledge. Consequently, researchers have advocated the use of rigorous behavioral theory in aiding epidemiological research and intervention. To test whether stage of change for 'insisting that men (besides your main partner) use condoms every time you have sex with them' was associated with behavioral attitudes, subjective norms, and self-efficacy among female crack cocaine users, a behavioral context questionnaire was administered to 61 female crack cocaine users who were recruited in the field and interviewed in an urban HIV testing center. Results indicated that all three were associated with stage of change and that self-efficacy was the variable most strongly related to stage of change. [ABSTRACT FROM AUTHOR]

Calcium phosphate materials, particularly hydroxyapatite (HA), are extensively used in biomedical applications because of their prominence as primary inorganic constituents of human hard tissues. This study investigates the synthesis of HA coatings via spray pyrolysis using various precursors, including HA derived from bovine bone. The effects of pH on the formation and properties of HA coatings were systematically examined. Samples exposed to acidic conditions or left without pH adjustment led to the formation of HA, contrasting with the outcomes observed through dissolution methods. Different characterization techniques, such as scanning electron microscopy (SEM), transmission electron microscopy (TEM), and X-ray diffraction (XRD), were employed to evaluate the quality and crystallinity of the coatings. Among the samples, those exhibiting superior crystallinity and nanostructured features, including bovine HA, were selected for further surface functionalization with the antibiotic enrofloxacin using spin coating. As expected, the antibiotic loading on each material's surface depended on the amount of HA deposited on the substrate. However, the desorption results indicated that, in all cases, desorption persisted beyond 38 h, implying that HA-loaded matrices could be effective systems for controlled and prolonged drug release, which could be useful in dental or orthopedic implants for inhibiting the growth of bacterial biofilms., (© 2024 The Author(s). Journal of Biomedical Materials Research Part B: Applied Biomaterials published by Wiley Periodicals LLC.)

Background: Communities That HEAL (CTH) is a novel, data-driven community-engaged intervention designed to reduce opioid overdose deaths by increasing community engagement, adoption of an integrated set of evidence-based practices, and delivering a communications campaign across healthcare, behavioral-health, criminal-legal, and other community-based settings. The implementation of such a complex initiative requires up-front investments of time and other expenditures (i.e., start-up costs). Despite the importance of these start-up costs in investment decisions to stakeholders, they are typically excluded from cost-effectiveness analyses. The objective of this study is to report a detailed analysis of CTH start-up costs pre-intervention implementation and to describe the relevance of these data for stakeholders to determine implementation feasibility., Methods: This study is guided by the community perspective, reflecting the investments that a real-world community would need to incur to implement the CTH intervention. We adopted an activity-based costing approach, in which resources related to hiring, training, purchasing, and community dashboard creation were identified through macro- and micro-costing techniques from 34 communities with high rates of fatal opioid overdoses, across four states-Kentucky, Massachusetts, New York, and Ohio. Resources were identified and assigned a unit cost using administrative and semi-structured-interview data. All cost estimates were reported in 2019 dollars., Results: State-level average and median start-up cost (representing 8-10 communities per state) were $268,657 and $175,683, respectively. Hiring and training represented 40%, equipment and infrastructure costs represented 24%, and dashboard creation represented 36% of the total average start-up cost. Comparatively, hiring and training represented 49%, purchasing costs represented 18%, and dashboard creation represented 34% of the total median start-up cost., Conclusion: We identified three distinct CTH hiring models that affected start-up costs: hospital-academic (Massachusetts), university-academic (Kentucky and Ohio), and community-leveraged (New York). Hiring, training, and purchasing start-up costs were lowest in New York due to existing local infrastructure. Community-based implementation similar to the New York model may have lower start-up costs due to leveraging of existing infrastructure, relationships, and support from local health departments., (© 2024. The Author(s).)

Substance use disorders (SUDs) and drug overdose are a public health emergency and safe and effective treatments are urgently needed. Developing new medications to treat them is expensive, time-consuming, and the probability of a compound progressing to clinical trials and obtaining FDA-approval is low. The small number of FDA-approved medications for SUDs reflects the low interest of pharmaceutical companies to invest in this area due to market forces, characteristics of the population (e.g., stigma, and socio-economic and legal disadvantages), and the high bar regulatory agencies set for new medication approval. In consequence, most research on medications is funded by government agencies, such as the National Institute on Drug Abuse (NIDA). Multiple scientific opportunities are emerging that can accelerate the discovery and development of new medications for SUDs. These include fast and efficient tools to screen new molecules, discover new medication targets, use of big data to explore large clinical data sets and artificial intelligence (AI) applications to make predictions, and precision medicine tools to individualize and optimize treatments. This review provides a general description of these new research strategies for the development of medications to treat SUDs with emphasis on the gaps and scientific opportunities. It includes a brief overview of the rising public health toll of SUDs; the justification, challenges, and opportunities to develop new medications; and a discussion of medications and treatment endpoints that are being evaluated with support from NIDA., Competing Interests: Declaration of Competing Interest All authors disclose that there is no financial and personal relationships with other people or organizations that could inappropriately influence (bias) the work. The include, potential competing interests include employment, consultancies, stock ownership, honoraria, paid expert testimony, patent applications/registrations, and grants or other funding., (Published by Elsevier Ltd.)

Introduction: The economic burden of substance use disorder (SUD) is significant, comprising costs of health care and social services, criminal justice resources, loss of productivity, and premature mortality. This study assembles and synthesizes two decades of evidence describing the benefits of SUD treatment across five main outcome domains; 1) health care utilization; 2) self-reported criminal activity by offense type; 3) criminal justice involvement collected from administrative records or self-reported; 4) productivity assessed through working hours or wages earned; and 5) social services (e.g., a day spent in transitional housing)., Methods: This review included studies if they reported the monetary value of the intervention outcomes, most commonly through a cost-benefit or cost-effectiveness framework. The search included studies from 2003 to the present day as of this writing (up to October 15, 2021). Summary cost estimates were adjusted using the US Consumer Price Index (CPI) to reflect the 12-month benefits per client in USD 2021. We followed the PRISMA methodology for study selection and assessed quality using the Checklist for Health Economic Evaluation Reporting Standards (CHEERS)., Results: The databases yielded 729 studies after removing duplicates, and we ultimately selected 12 for review. Studies varied widely regarding analytical approaches, time horizons, outcome domains, and other methodological factors. Among the ten studies that found positive economic benefits, reductions in criminal activity or criminal justice costs represented the largest or second largest component of these benefits (range $621 to $193,440 per client)., Conclusions: Consistent with previous findings, a reduction in criminal activity costs is driven by the relatively high societal cost per criminal offense, notably for violent crimes, such as aggravated assault and rape/sexual assault. Accepting the economic rationale for increased investment in SUD interventions will require recognizing that more benefits accrue to individuals by avoiding being victims of a crime than to governments through budget offsets resulting from savings in non-SUD program expenses. Future studies should explore individually tailored interventions to optimize care management, which may yield unexpected economic benefits to services utilization, and criminal activity data to estimate economic benefits across a broad range of interventions., Competing Interests: Declaration of competing interest None., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Introduction: Reducing substance-related morbidity requires an educated and well-supported workforce. The New England Office Based Addiction Treatment Extension for Community Healthcare Outcomes (NE OBAT ECHO) began in 2019 to support community-based addiction care teams through virtual mentoring and case-based learning. We sought to characterize the program's impact on the knowledge and attitudes of NE OBAT ECHO participants., Methods: We conducted an 18-month prospective evaluation of the NE OBAT ECHO. Participants registered for 1 of 2 successive ECHO clinics. Each 5-month clinic included ten 1.5-hour sessions involving brief didactic lectures and de-identified patient case presentations. Participants completed surveys at Month-0, -6, -12, and -18 to assess attitudes about working with patients who use drugs and evidence based practices (EBPs), stigma toward people who use drugs, and addiction treatment knowledge. We compared outcomes using 2 approaches: (i) between-groups, which involved comparing the first intervention group to the delayed intervention (comparison) group, and (ii) within-groups, which involved comparing outcomes at different time points for all participants. In the within-group approach, each participant acted as their own control., Results: Seventy-six health professionals participated in the NE OBAT ECHO, representing various roles in addiction care teams. Approximately half (47% [36/76]) practiced primary care, internal, or family medicine. The first intervention group reported improved job satisfaction and openness toward EBPs compared to the delayed intervention group. Within-group analyses revealed that ECHO participation was associated with increased positive perceptions of role adequacy, support, legitimacy, and satisfaction 6 months following program completion. No changes were identified in willingness to adopt EBPs or treatment knowledge. Stigma toward people who use drugs was persistent in both groups across time points., Conclusions: NE OBAT ECHO may have improved participants' confidence and satisfaction providing addiction care. ECHO is likely an effective educational tool for expanding the capacity of the addiction workforce., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: Given the personal and public consequences of untreated/undertreated OUD among persons involved in the justice system, an increasing number of jails and prisons are incorporating medication for opioid use disorder (MOUD) into their system. Estimating the costs of implementing and sustaining a particular MOUD program is vital to detention facilities, which typically face modest, fixed health care budgets. We developed a customizable budget impact tool to estimate the implementation and sustainment costs of numerous MOUD delivery models for detention facilities., Methods: The aim is to describe the tool and present an application of a hypothetical MOUD model. The tool is populated with resources required to implement and sustain various MOUD models in detention facilities. We identified resources via micro-costing techniques alongside randomized clinical trials. The resource-costing method is used to assign values to resources. Resources/costs are categorized as (a) fixed, (b) time-dependent, and (c) variable. Implementation costs include (a), (b), and (c) over a specified timeframe. Sustainment costs include (b) and (c). The MOUD model example entails offering all three FDA-approved medications, with methadone and buprenorphine provided by vendors, and naltrexone by the jail/prison facility., Results: Fixed resources/costs are incurred only once, including accreditation fees and trainings. Time-dependent resources/costs are recurring, but fixed over a given time-period; e.g., medication delivery and staff meetings. Variable resources/costs are those that are a direct function of the number of persons treated, such as the medication provided to each patient. Using nationally representative prices, we estimated fixed/sustainment costs to be $2919/patient, over 1 year. This article estimates annual sustainment costs to be $2885/patient., Conclusion: The tool will serve as a valuable asset to jail/prison leadership, policymakers, and other stakeholders interested in identifying/estimating the resources and costs associated with alternative MOUD delivery models, from the planning stages through sustainment., Competing Interests: Declaration of competing interest No competing interests to declare., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Seven new Casiopeinas® were synthesized and properly characterized. These novel compounds have a general formula [Cu(N-N)( Indo )]NO 3 , where Indo is deprotonated indomethacin and N-N is either bipyridine or phenanthroline with some methyl-substituted derivatives, belonging to the third generation of Casiopeinas®. Spectroscopic characterization suggests a square-based pyramid geometry and voltammetry experiments indicate that the redox potential is strongly dependent on the N-N ligand. All the presented compounds show high cytotoxic efficiency, and most of them exhibit higher efficacy compared to the well-known cisplatin drug and acetylacetonate analogs of the first generation. Computational calculations show that antiproliferative behavior can be directly related to the volume of the molecules. Besides, a chitosan (CS)-polyacrylamide (PNIPAAm) nanogel was synthesized and characterized to examine the encapsulation and release properties of the [Cu(4,7-dimethyl-1,10-phenanthroline)( Indo )]NO 3 compound. The results show good encapsulation performance in acidic conditions and a higher kinetic drug release in acidic media than at neutral pH. This result can be described by the Peppas-Sahlin model and indicates a release mechanism predominantly by Fick diffusion., Competing Interests: The authors declare no conflict of interest., (This journal is © The Royal Society of Chemistry.)

Introduction: The subjective experience of drug craving is a prominent and common clinical phenomenon for many individuals diagnosed with opioid use disorder (OUD), and could be a valuable clinical endpoint in medication development studies. The purpose of this scoping review is to provide an overview and critical analysis of opioid craving assessments located in the published literature examining OUD., Method: Studies were identified through a search of PubMed, Embase, and PsychInfo databases and included for review if opioid craving was the focus and participants were diagnosed with or in treatment for OUD., Results: Fifteen opioid craving assessment instruments were identified across the 87 studies included for review. The most common were the Visual Analog Scale (VAS, 41 studies), Desires for Drug Questionnaire (DDQ, 12 studies), Heroin Craving Questionnaire (HCQ, 10 studies), and Obsessive-Compulsive Drug Use Scale (OCDUS, 10 studies). Craving assessments varied considerably in their format, content, time frame, and underlying subscales, and only 6 of 15 had been psychometrically evaluated., Discussion: This review identified a variety of opioid craving assessments, but few had been evaluated for their psychometric properties making it difficult to ascertain whether craving is being assessed optimally in studies of OUD. Thus, the development of a reliable and valid opioid craving assessment would be worthwhile and could be guided by recently published Food and Drug Administration Clinical Outcome Assessment (COA) guidelines. Importantly, a COA focused on opioid craving could be a valuable addition to research studies designed to evaluate novel treatments for OUD., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Accurate assessment of inappropriate medication use events (ie, misuse, abuse, and related events) occurring in clinical trials is an important component in evaluating a medication's abuse potential. A meeting was convened to review all instruments measuring such events in clinical trials according to previously published standardized terminology and definitions. Only 2 approaches have been reported that are specifically designed to identify and classify misuse, abuse, and related events occurring in clinical trials, rather than to measure an individual's risk of using a medication inappropriately: the Self-Reported Misuse, Abuse, and Diversion (SR-MAD) instrument and the Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS). The conceptual basis, strengths, and limitations of these methods are discussed. To our knowledge, MADDERS is the only system available to comprehensively evaluate inappropriate medication use events prospectively to determine the underlying intent. MADDERS can also be applied retrospectively to completed trial data. SR-MAD can be used prospectively; additional development may be required to standardize its implementation and fully appraise the intent of inappropriate use events. Additional research is needed to further demonstrate the validity and utility of MADDERS as well as SR-MAD., Perspective: Identifying a medication's abuse potential requires assessing inappropriate medication use events in clinical trials on the basis of a standardized event classification system. The strengths and limitations of the 2 published methods designed to evaluate inappropriate medication use events are reviewed, with recommended considerations for further development and current implementation., (Copyright © 2017 American Pain Society. Published by Elsevier Inc. All rights reserved.)

Both random walk and respondent-driven sampling (RDS) exploit social networks and may reduce biases introduced by earlier methods for sampling from hidden populations. Although RDS has become much more widely used by social researchers than random walk (RW), there has been little discussion of the tradeoffs in choosing RDS over RW. This paper compares experiences of implementing RW and RDS to recruit drug users to a network-based study in Houston, Texas. Both recruitment methods were implemented over comparable periods of time, with the same population, by the same research staff. RDS methods recruited more participants with less strain on staff. However, participants recruited through RW were more forthcoming than RDS participants in helping to recruit members of their social networks. Findings indicate that, dependent upon study goals, researchers' choice of design may influence participant recruitment, participant commitment, and impact on staff, factors that may in turn affect overall study success., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: The development and approval of an efficacious pharmacotherapy for stimulant use disorders has been limited by the lack of a meaningful indicator of treatment success, other than sustained abstinence., Methods: In March, 2015, a meeting sponsored by Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) was convened to discuss the current state of the evidence regarding meaningful outcome measures in clinical trials for stimulant use disorders. Attendees included members of academia, funding and regulatory agencies, pharmaceutical companies, and healthcare organizations. The goal was to establish a research agenda for the development of a meaningful outcome measure that may be used as an endpoint in clinical trials for stimulant use disorders., Results and Conclusions: Based on guidelines for the selection of clinical trial endpoints, the lessons learned from prior addiction clinical trials, and the process that led to identification of a meaningful indicator of treatment success for alcohol use disorders, several recommendations for future research were generated. These include a focus on the validation of patient reported outcome measures of functioning, the exploration of patterns of stimulant abstinence that may be associated with physical and/or psychosocial benefits, the role of urine testing for validating self-reported measures of stimulant abstinence, and the operational definitions for reduction-based measures in terms of frequency rather than quantity of stimulant use. These recommendations may be useful for secondary analyses of clinical trial data, and in the design of future clinical trials that may help establish a meaningful indicator of treatment success., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

Sandwich structures were fabricated by a vacuum deposition method using MPc (M = Cu, Zn), with a Tetrathiafulvalene (TTF) derivative, and Indium Tin Oxide (ITO) and aluminum electrodes. The structure and morphology of the deposited films were studied by IR spectroscopy, scanning electron microscopy (SEM) and energy dispersive spectroscopy (EDS). The absorption spectra of TTF derivative-MPc (M = Cu, Zn) thin films deposited at room temperature were recorded in the spectral range 200-1000 nm. The optical band gap of the thin films was determined from the (αhν)(1/2) vs. hν plot. The direct-current (DC) electrical properties of the glass/ITO/TTFderiv-MPc (M = Cu, Zn)/Al structures were also investigated. Changes in conductivity of the derivative-TTF-enriched Pc compounds suggest the formation of alternative paths for carrier conduction. At low voltages, forward current density obeys an ohmic I-V relationship; at higher voltages, conduction is mostly due to a space-charge-limited conduction (SCLC) mechanism.

Background: The Food and Drug Administration can set standards that reduce the nicotine content of cigarettes., Methods: We conducted a double-blind, parallel, randomized clinical trial between June 2013 and July 2014 at 10 sites. Eligibility criteria included an age of 18 years or older, smoking of five or more cigarettes per day, and no current interest in quitting smoking. Participants were randomly assigned to smoke for 6 weeks either their usual brand of cigarettes or one of six types of investigational cigarettes, provided free. The investigational cigarettes had nicotine content ranging from 15.8 mg per gram of tobacco (typical of commercial brands) to 0.4 mg per gram. The primary outcome was the number of cigarettes smoked per day during week 6., Results: A total of 840 participants underwent randomization, and 780 completed the 6-week study. During week 6, the average number of cigarettes smoked per day was lower for participants randomly assigned to cigarettes containing 2.4, 1.3, or 0.4 mg of nicotine per gram of tobacco (16.5, 16.3, and 14.9 cigarettes, respectively) than for participants randomly assigned to their usual brand or to cigarettes containing 15.8 mg per gram (22.2 and 21.3 cigarettes, respectively; P<0.001). Participants assigned to cigarettes with 5.2 mg per gram smoked an average of 20.8 cigarettes per day, which did not differ significantly from the average number among those who smoked control cigarettes. Cigarettes with lower nicotine content, as compared with control cigarettes, reduced exposure to and dependence on nicotine, as well as craving during abstinence from smoking, without significantly increasing the expired carbon monoxide level or total puff volume, suggesting minimal compensation. Adverse events were generally mild and similar among groups., Conclusions: In this 6-week study, reduced-nicotine cigarettes versus standard-nicotine cigarettes reduced nicotine exposure and dependence and the number of cigarettes smoked. (Funded by the National Institute on Drug Abuse and the Food and Drug Administration Center for Tobacco Products; ClinicalTrials.gov number, NCT01681875.).

Alcohol is the most widely abused substance in the United States and its pathology is responsible for more pathological conditions than all other forms of drug use combined. Alcohol dependence is associated with a number of adverse individual and societal consequences and high rates of morbidity and mortality. Alcohol use and abuse have a significant pathological effect on the brain, fetus, liver, heart, pancreas, and immune system. Cancer risks have also been attributed to alcohol use and abuse. Assessing acute and chronic alcohol consumption is critical to effective treatment but unfortunately currently available clinical laboratory testing procedures lack the ability to inform alcohol treatment providers about use and abuse.

As the nontherapeutic use of prescription medications escalates, serious associated consequences have also increased. This makes it essential to estimate misuse, abuse, and related events (MAREs) in the development and postmarketing adverse event surveillance and monitoring of prescription drugs accurately. However, classifications and definitions to describe prescription drug MAREs differ depending on the purpose of the classification system, may apply to single events or ongoing patterns of inappropriate use, and are not standardized or systematically employed, thereby complicating the ability to assess MARE occurrence adequately. In a systematic review of existing prescription drug MARE terminology and definitions from consensus efforts, review articles, and major institutions and agencies, MARE terms were often defined inconsistently or idiosyncratically, or had definitions that overlapped with other MARE terms. The Analgesic, Anesthetic, and Addiction Clinical Trials, Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership convened an expert panel to develop mutually exclusive and exhaustive consensus classifications and definitions of MAREs occurring in clinical trials of analgesic medications to increase accuracy and consistency in characterizing their occurrence and prevalence in clinical trials. The proposed ACTTION classifications and definitions are designed as a first step in a system to adjudicate MAREs that occur in analgesic clinical trials and postmarketing adverse event surveillance and monitoring, which can be used in conjunction with other methods of assessing a treatment's abuse potential., (Copyright © 2013 International Association for the Study of Pain. All rights reserved.)

In response to evidence that adverse medical events are widespread, patient safety programs have emerged and proliferated worldwide in recent years. Patient safety may be considered a new and distinct healthcare discipline. It emphasizes the reporting, analysis, and prevention of medical errors that can lead to adverse healthcare events. While this is a useful generic definition, it takes on different meanings for each healthcare discipline. When patient safety programs were studied, it was found that many are generic and may be inappropriately focused and researched. In planning a patient safety program, the basis of patient safety programs for all disciplines will have similarities. But each discipline will require nuances specific to the discipline since the goals, objectives, and requirements of each are unique. Furthermore, each discipline will have its own preferred outcomes that may change over time as new data become available and service providers become more knowledgeable of ways to increase the likelihood of desired outcomes.

Drug addictions are complex disorders that require multiple approaches, including the use of pharmacotherapies. Currently, these therapies are based on "small" molecules or chemicals that penetrate the blood-brain barrier, reach the brain, and produce their effects on neurotransmitter systems. Unfortunately, they often do not have the desired efficacy or may cause undesirable side effects, especially at the central nervous system (CNS) level. A novel approach is the use of biologics to treat drug addictions. Biologics are usually complex and "large" molecules, which do not cross the blood-brain barrier and, thus, have no CNS effects. In principle, it appears that the efficacy of biologics to treat drug addiction is by preventing the access of the drug of abuse to the brain, preventing the activation of brain reward systems, and eventually producing the extinction of addiction. Biologic therapeutics includes immunotherapies, such as vaccines or antibodies, as well as enzymes. New products as well as new and more efficient methods of production, are offering vast opportunities to advance the discovery and development of biologics to treat addictions as well as drug overdose. These products include new vaccines with greater specificity and ability to produce antibodies, new methods and techniques to produce vaccines and antibodies, as well as new enzymes with high efficiency to metabolize cocaine. The purpose of the article is to provide a general overview of the development of biologics for the treatment of drug addictions and overdose.

Cigarette smoking is common among patients in cocaine and opioid dependence treatment, and may influence treatment outcome. We addressed this issue in a secondary analysis of data from an outpatient clinical trial of buprenorphine treatment for concurrent cocaine and opioid dependence (13 weeks, N=200). The association between cigarette smoking (lifetime cigarette smoking status, number of cigarettes smoked per day prior to study entry) and short-term treatment outcome (% of urine samples positive for cocaine or opioids, treatment retention) was evaluated with analysis of covariance, bivariate correlations, and multivariate linear regression. Nicotine-dependent smokers (66% of participants) had a significantly higher percentage of cocaine-positive urine samples than non-smokers (12% of participants) (76% vs. 62%), but did not differ in percentage of opioid-positive urine samples or treatment retention. Number of cigarettes smoked per day at baseline was positively associated with percentage of cocaine-positive urine samples, even after controlling for baseline sociodemographic and drug use characteristics, but was not significantly associated with percentage of opioid-positive urine samples or treatment retention. These results suggest that cigarette smoking is associated with poorer short-term outcome of outpatient treatment for cocaine dependence, but perhaps not of concurrent opioid dependence, and support the importance of offering smoking cessation treatment to cocaine-dependent patients., (Published by Elsevier Ireland Ltd.)

Background: The regulation implementing the Patient Safety and Quality Improvement Act of 2005 (PSQIA) was published on November 21, 2008, and became effective on January 19, 2009 (42 C.F.R. Part 3). PSQIA establishes a voluntary reporting system to enhance the data available to assess and resolve patient safety and health care quality issues. To encourage the reporting and analysis of medical errors, PSQIA provides federal privilege and confidentiality protections for patient safety information., Purpose: Greater reporting and analysis of patient safety events will yield increased data and better understanding of patient safety events. A PSO's workforce must have expertise in analyzing patient safety events, such as the identification, analysis, prevention, and reduction or elimination of the risks and hazards associated with the delivery of patient care., Implications: This new legislation provides a vehicle to better understand at a macro level how the clinical laboratory threatens patient safety and how that threat can be better controlled. What is imperative is that the clinical laboratory staff be involved in collecting and analyzing data. If they are not, the probability is high that data being reported by the laboratory will be misunderstood at the PSO and laboratories may be cited as a threat to patient safety because of a lack of understanding of laboratory operations.

Illicit drug intoxications are an increasing public health problem for which, in most cases, no antidotes are clinically available. The diagnosis and treatment of these intoxications requires a trained clinician with experience in recognizing the specific signs and symptoms of intoxications to individual drugs as well as polydrug intoxications, which are more the rule than the exception. To make the diagnosis, the clinical observation and a urine toxicology test are often enough. Evaluating the blood levels of drugs is frequently not practical because the tests can be expensive and results may be delayed and unavailable to guide the establishment of a treatment plan. Other laboratory tests may be useful depending on the drug or drugs ingested and the presence of other medical complications. The treatment should be provided in a quiet, safe and reassuring environment. Vital signs should be closely monitored. Changes in blood pressure, respiratory frequency and temperature should be promptly treated, particularly respiratory depression (in cases of opiate intoxication) or hyperthermia (in cases of cocaine or amphetamine intoxication). Intravenous fluids should be administered as soon as possible. Other psychiatric and medical complication should receive appropriate symptomatic treatment. Research on immunotherapies, including vaccines, monoclonal and catalytic antibodies, seems to be a promising approach that may yield specific antidotes for drugs of abuse, helping to ameliorate the morbidity and mortality associated with illicit drug intoxications.

People with mental health and addictive (MHA) disorders smoke at high rates and require tobacco treatment as a part of their comprehensive psychiatric care. Psychiatric care providers often do not address tobacco use among people with mental illness, possibly owing to the belief that their patients will not be able to quit successfully or that even short-term abstinence will adversely influence psychiatric status. Progress in the development of treatments has been slow in part because smokers with current MHA disorders have been excluded from most smoking cessation trials. There are several smoking cessation treatment options, including psychological and pharmacological interventions, that should be offered to people with an MHA disorder who smoke. Building motivation and readiness to quit smoking is a major challenge, and therefore motivational interventions are essential. We review the treatment options for people with tobacco dependence and MHA disorders, offer recommendations on tobacco assessment and tailored treatment strategies, and provide suggestions for future research. Treatment efficacy could be enhanced through promoting smoking reduction as an initial treatment goal, extending duration of treatment, and delivering it within an integrated care model that also aims to reduce the availability of tobacco in MHA treatment settings and in the community.

Background: US national healthcare expenditure reached over 2 trillion dollars in 2007. medical device expenditure has remained nearly a constant 6% of the total healthcare expenditure. medical technology may be one of the driving factors increasing healthcare costs. the number of medical device (which includes diagnostic tests) and laboratory equipment manufacturers, and investment in research for medical devices continue to rise. medical device manufacturers can receive a higher than average return on investment if they successfully navigate the food and drug administration (FDA) approval process., Objective: this paper focuses on the series of steps a manufacturer can pursue to facilitate the introduction of a new device to the us market., Method: a review of the FDA regulations and current literature was conducted., Results/conclusion: exemption from a full review by the FDA owing to substantial equivalence is one of the pathways a manufacturer can pursue for quicker and easier approval of the new device. three classes of devices are reviewed, as are some of the key regulations governing them. the regulations for advertising and promotion are still unclear because of the gray area that exists between the federal trade commission and the FDA. this paper concludes by summarizing the advertising and promotion regulations set forth by the FDA during the post-approval phase.

Recent discoveries about the effects of drugs of abuse on the brain and the mechanisms of their addictions; new chemical compounds, including immunotherapies; and new actions of available medications are offering many opportunities for the discovery and development of novel medications to treat addictive disorders. Furthermore, advancements in the understanding of the genetic and epigenetic basis of drug addiction and the pharmacogenetics of the safety and/or efficacy of the medications are providing opportunities for more individualized pharmacotherapy approaches. Although multiple medications have been investigated for treating addictions, only a handful have shown acceptable safety and efficacy and are approved by the US Food and Drug Administration. This article reviews the current medications that are medically safe and have shown promising results for treating opioid, cocaine, methamphetamine, and cannabis addictions.

The Institute of Medicine has identified adverse drug events as factors that significantly contribute to increased patient morbidity and mortality. As critically ill patients receive numerous drugs to treat a multitude of complicated health problems, they are at high risk for adverse drug events. Sedation is often a key requirement for the optimal management of critical illness, and propofol, a common sedative, has many desirable characteristics that make it the ideal agent in numerous circumstances. However, over the last decade, increasing numbers of reports have described a potentially fatal adverse effect called propofol-related infusion syndrome. Whether this adverse drug event is preventable is unclear, but recommendations have been proposed to minimize the potential for development of this syndrome. Research is under way to collect data on the use of propofol in intensive care units and on its prevalence.

Over the past decade, clinical doctorate programs in health disciplines have proliferated amid both support and controversy among educators, professional organizations, practitioners, administrators, and third-party payers. Supporters argue that the explosion of new knowledge and increasing sophistication of technology have created a need for advanced practice models to enhance patient care and safety and to reduce costs. Critics argue that necessary technological advances can be incorporated into existing programs and believe that clinical doctorates will increase health care costs, not reduce them. Despite the controversy, many health disciplines have advanced the clinical doctorate (the most recent is the doctor of nursing practice in 2004), with some professions mandating the doctorate as the entry-level degree (i.e., psychology, pharmacy, audiology, and so on). One aspect of the introduction of clinical doctoral degrees has been largely overlooked, and that is the marketing aspect. Because of marketing considerations, some clinical doctorates have been more successfully implemented and accepted than others. Marketing is composed of variables commonly known as "the four P's of marketing": product, price, promotion, and place. This report explores these four P's within the context of clinical doctorates in the health disciplines.

Sales of consumer products over the Internet have grown rapidly, including sales of pharmaceutical products. Online pharmacies mimic mail order pharmacies. To operate legally online, pharmacies must be licensed in every state in which sales occur. Although online pharmacies provide benefits to consumers, when compared with traditional pharmacies patients' safety may be compromised. Purchasing prescription drugs online may pose a risk to consumers because they cannot tell whether the site is offering drugs of the same quality offered by a retail pharmacy. There is also a possibility that prescription drugs purchased online may be counterfeit, illegal, or unapproved. A U.S. General Accounting Office study conducted in June 2004 showed that most counterfeit and unapproved drugs sold online are from non-U.S. pharmacies. The Food and Drug Administration and other government agencies have worked to enforce laws on drug sales over the Internet. The biggest challenge in regulating non-U.S. pharmacies is due to their off-shore location. Unfortunately, given the widespread anonymous and ever-changing nature of the Internet, it is very difficult to close down illegal websites.

The goal of this article is to examine whether profit status affects the provision of seven "core" drug treatment services and nine "auxiliary" treatment services. Data on the type of services provided by 8,606 treatment providers obtained from the National Survey of Substance Abuse Treatment Services (N-SSATS) collected by the Substance Abuse and Mental Health Services Administration (SAMHSA) in 2000 were used for this study. The types of services offered by the providers were modeled to be a function of the drug treatment providers' (DTP) profit status, DTP organizational and financial characteristics, staff's characteristics, clients' characteristics, and regional variables. A total of 16 logistic regressions were estimated. For-profit DTPs were found to be more likely to offer only two core services and were less likely to offer eight auxiliary services. However, after correcting for sample selection bias many differences in the supply of services between for-profit and nonprofit providers disappeared.

After 24 years of being declared an epidemic, the human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) has found its way to the remote parts of the Middle East. There are no fastidious HIV/AIDS epidemiological data available specific for the Middle East and insufficient surveys have been conducted in a larger area including the Middle East and North Africa. Currently the total number of people living with HIV in the Middle East and North Africa is 540,000. About 92,000 individuals were newly infected in 2004 and 28,000 people have died of AIDS during the same time period.2 With increasing spread of sexually transmitted infections (STIs), injection drug users (IDUs), numbers of unemployed youth, a conservative culture and low awareness of HIV the region is especially vulnerable to a large-scale epidemic. In this age of globalization the rapid spread of HIV along with highly virulent and multi-drug-resistant HIV strains that progress rapidly to AIDS, the more difficult and expensive prevention efforts and treatment regimes become. Complicating the issue there are many unresolved socio-economic conflicts in the Middle East. Valid and reliable HIV/AIDS epidemiological data, to facilitate policy formulation and to effect urgent prevention intervention is inadequate. This article identifies numerous gaps and shortfalls in the existing programs, elucidates the reasons behind the lack of information, and provides suggestions for taking actions.

This study examined the prevalence of exposure to violence among drug-dependent pregnant women attending a multidisciplinary perinatal substance abuse treatment program. Participants (N = 715) completed the Violence Exposure Questionnaire within 7 days after their admission to the program. Their rates of lifetime abuse ranged from 72.7% for physical abuse to 71.3% for emotional abuse to 44.5% for sexual abuse. Their rates of abuse remained high during their current pregnancy, ranging from 40.9% for emotional abuse to 20.0% for physical abuse to 7.1% for sexual abuse. Nearly one third of the women reported having physical fights with their current partner (lifetime), and 25% of these women reported that children were present during those physical fights. A total of 30% of the women perceived a need for counseling regarding exposure to violence for themselves and 15% perceived a need for counseling for their children. Study findings confirm previous reports of high rates of abuse and violence exposure among substance-abusing pregnant women and their strong need for counseling for psychosocial sequelae. This study affirmed the value of routine screening for violence exposure in this at-risk population as well as the need to train therapists in specific strategies for helping such women address this complex array of problems.

This article examines the extent to which Temporary Assistance to Needy Families (TANF) recipients file income tax returns and take advantage of the Earned Income Credit (EIC), a program specifically designed to increase the economic self-sufficiency of lower income earners by supplementing earned and other income to make working more profitable. This study consisted primarily of Black and Hispanic women (n = 317), recruited for a longitudinal study designed to examine the effects of welfare reform on drug using and non-drug using welfare recipients. At the 2-year mark, 70% of the sample reported having ever filed an income tax return, of these 76% had received an EIC. Both hours worked and earnings were positively associated with EIC receipt. In this population, EIC appears to be a successful mechanism for improving economic self-sufficiency.