Answering questions about electronic cigarettes using a multidisciplinary model.

Electronic cigarettes (ECIGs) are a relatively new class of tobacco products and a subject of much debate for scientists and policymakers worldwide. Objective data that address the ECIG risk-benefit ratio for individual and public health are needed, and addressing this need requires a multidisciplinary approach that spans several areas of psychology as well as chemistry, toxicant inhalation, and physiology. This multidisciplinary approach would benefit from methods that are reliable, valid, and swift. For this reason, we formed a multidisciplinary team to develop methods that could answer questions about ECIGs and other potential modified risk tobacco products. Our team includes scientists with expertise in psychology (clinical, community, and experimental) and other disciplines, including aerosol research, analytical chemistry, biostatistics, engineering, internal medicine, and public health. The psychologists on our team keep other members focused on factors that influence individual behavior, and other team members keep the psychologists aware of other issues, such as product design. Critically, all team members are willing to extend their interests beyond the boundaries of their discipline to collaborate effectively with the shared goal of producing the rigorous science needed to inform empirically based tobacco policy. In addition, our trainees gain valuable knowledge from these collaborations and learn that other disciplines are accessible, exciting, and can enhance their own research. Multidisciplinary work presents challenges: learning other scientists' languages and staying focused on our core mission. Overall, our multidisciplinary team has led to several major findings that inform the scientific, regulatory, and public health communities about ECIGs and their effects. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Smoking Behaviors in Arab Americans: Acculturation and Health Beliefs.

INTRODUCTION: Arab Americans are a growing population in the United States. In the 2011 American Community Survey, the U.S. Census Bureau reported there were close to 1.8 million Arab Americans living within the United States, a 47% increase in population size from 2000. According to the Arab American Institute, currently, that estimate has grown to approximately 3.7 million. They have high rates of smoking and low rates of smoking cessation. In this study, the researchers investigated factors influencing desire to quit smoking among Arab Americans, and their association with acculturation and health beliefs. METHODOLOGY: Cross-sectional descriptive study investigating smoking behaviors and factors influencing the desire to quit smoking among adult Arab American. Data were collected to measure tobacco use, nicotine dependence, desire to quit smoking, acculturation, and health beliefs. RESULTS: The sample ( N = 96) was 55% female, mean age of 44 years (±14.79). The desire to quit smoking was positively associated with perceived severity (p < .05) and susceptibility to cancer (p < .05), perceived benefits of quitting smoking ( p < .01); and negatively associated with smoking barriers (addiction barriers p < .05, external barriers p = .27, internal barriers p < .05), and nicotine dependence (p < .05). Being female, having a lower level of nicotine dependence, and a higher perception of cancer severity predicted higher desire to quit smoking ( p < .01). DISCUSSION: Smoking cessation intervention studies need to target appropriate health beliefs, especially the high risk of cancer caused by smoking among Arab Americans.

Evidence acquisition and evaluation for evidence summit on population-level behavior change to enhance child survival and development in low- and middle-income countries.

Recognizing the need for evidence to inform public health officials and health care workers in the U.S. government and low- and middle-income country governments on efficient, effective behavior change policies, strategies, and programs for child health and development, the U.S. government convened the Evidence Summit on Enhancing Child Survival and Development in Lower- and Middle-Income Countries by Achieving Population-Level Behavior Change. This article summarizes the background and methods for the acquisition and evaluation of the evidence used to the achieve the goals of the summit that is reviewed in other articles in this special issue of the Journal of Health Communication. The process began by identifying focal questions intended to inform the U.S. and low- and middle-income governments about behavior change interventions that accelerate reductions in under-5 mortality and optimize healthy and protective child development to 5 years of age. Experts were selected representing the research and program communities, academia, relevant nongovernmental organizations, and government agencies and assembled into evidence review teams. This was followed by the systematic gathering of relevant peer-reviewed literature that would inform the focal questions. Members of the evidence review teams were invited to add relevant articles not identified in the initial literature review to complete the bibliographies. Details of the search processes and methods used for screening and quality reviews are described. The evidence review teams were asked to comply with a specific evaluation framework for recommendations on practice and policy on the basis of both expert opinion and the quality of the data reviewed.

William L. Woolverton: a case history in unraveling the behavioral pharmacology of stimulants.

Clinical findings suggest that the most promising strategy for cocaine addiction is a combination of indirect-acting monoamine agonists with some form of behavioral intervention. This approach can be traced back to preclinical research, some of which was conducted by William L. Woolverton. The goal of this brief review is to provide readers with an appreciation for the experimental breadth involving both behavior and pharmacology that encompassed Woolverton's amazing career, from the evaluation of abuse liability of drugs to the use of complex behavioral contingencies to better model the human condition. We begin with Woolverton's research using simple and complex schedules of reinforcement to evaluate abuse liability and how that has impacted current animal models. We also discuss his use of cocaine vs. food choice schedules of reinforcement as a model to evaluate potential medications for treating cocaine use disorders. Woolverton concluded that drug taking behavior was not "impulsive" and "out of control" as has often been proposed, but rather directly determined by the environmental contingencies and the context of its availability, providing a nuanced understanding of drug-behavior interactions. This article is part of the Special Issue entitled 'CNS Stimulants'

Abuse liability measures for use in analgesic clinical trials in patients with pain: IMMPACT recommendations.

Assessing and mitigating the abuse liability (AL) of analgesics is an urgent clinical and societal problem. Analgesics have traditionally been assessed in randomized clinical trials (RCTs) designed to demonstrate analgesic efficacy relative to placebo or an active comparator. In these trials, rigorous, prospectively designed assessment for AL is generally not performed. The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) convened a consensus meeting to review the available evidence and discuss methods for improving the assessment of the AL of analgesics in clinical trials in patients with pain. Recommendations for improved assessment include: (1) performing trials that include individuals with diverse risks of abuse; (2) improving the assessment of AL in clinical trials (eg, training study personnel in the principles of abuse and addiction behaviors, designing the trial to assess AL outcomes as primary or secondary outcome measures depending on the trial objectives); (3) performing standardized assessment of outcomes, including targeted observations by study personnel and using structured adverse events query forms that ask all subjects specifically for certain symptoms (such as euphoria and craving); and (4) collecting detailed information about events of potential concern (eg, unexpected urine drug testing results, loss of study medication, and dropping out of the trial). The authors also propose a research agenda for improving the assessment of AL in future trials.

GLYX-13, a NMDA receptor glycine-site functional partial agonist, induces antidepressant-like effects without ketamine-like side effects.

Recent human clinical studies with the NMDA receptor (NMDAR) antagonist ketamine have revealed profound and long-lasting antidepressant effects with rapid onset in several clinical trials, but antidepressant effects were preceded by dissociative side effects. Here we show that GLYX-13, a novel NMDAR glycine-site functional partial agonist, produces an antidepressant-like effect in the Porsolt, novelty induced hypophagia, and learned helplessness tests in rats without exhibiting substance abuse-related, gating, and sedative side effects of ketamine in the drug discrimination, conditioned place preference, pre-pulse inhibition and open-field tests. Like ketamine, the GLYX-13-induced antidepressant-like effects required AMPA/kainate receptor activation, as evidenced by the ability of NBQX to abolish the antidepressant-like effect. Both GLYX-13 and ketamine persistently (24 h) enhanced the induction of long-term potentiation of synaptic transmission and the magnitude of NMDAR-NR2B conductance at rat Schaffer collateral-CA1 synapses in vitro. Cell surface biotinylation studies showed that both GLYX-13 and ketamine led to increases in both NR2B and GluR1 protein levels, as measured by Western analysis, whereas no changes were seen in mRNA expression (microarray and qRT-PCR). GLYX-13, unlike ketamine, produced its antidepressant-like effect when injected directly into the medial prefrontal cortex (MPFC). These results suggest that GLYX-13 produces an antidepressant-like effect without the side effects seen with ketamine at least in part by directly modulating NR2B-containing NMDARs in the MPFC. Furthermore, the enhancement of 'metaplasticity' by both GLYX-13 and ketamine may help explain the long-lasting antidepressant effects of these NMDAR modulators. GLYX-13 is currently in a Phase II clinical development program for treatment-resistant depression.

Financial incentives and maternal health: where do we go from here?

Health financing strategies that incorporate financial incentives are being applied in many low- and middle-income countries, and improving maternal and neonatal health is often a central goal. As yet, there have been few reviews of such programmes and their impact on maternal health. The US Government Evidence Summit on Enhancing Provision and use of Maternal Health Services through Financial Incentives was convened on 24-25 April 2012 to address this gap. This article, the final in a series assessing the effects of financial incentives--performance-based incentives (PBIs), insurance, user fee exemption programmes, conditional cash transfers, and vouchers--summarizes the evidence and discusses issues of context, programme design and implementation, cost-effectiveness, and sustainability. We suggest key areas to consider when designing and implementing financial incentive programmes for enhancing maternal health and highlight gaps in evidence that could benefit from additional research. Although the methodological rigor of studies varies, the evidence, overall, suggests that financial incentives can enhance demand for and improve the supply of maternal health services. Definitive evidence demonstrating a link between incentives and improved health outcomes is lacking; however, the evidence suggests that financial incentives can increase the quantity and quality of maternal health services and address health systems and financial barriers that prevent women from accessing and providers from delivering quality, lifesaving maternal healthcare.

Evidence acquisition and evaluation for evidence summit on enhancing provision and use of maternal health services through financial incentives.

Recognizing the need for evidence to inform US Government and governments of the low- and middle-income countries on efficient, effective maternal health policies, strategies, and programmes, the US Government convened the Evidence Summit on Enhancing Provision and Use of Maternal Health Services through Financial Incentives in April 2012 in Washington, DC, USA. This paper summarizes the background and methods for the acquisition and evaluation of the evidence used for achieving the goals of the Summit. The goal of the Summit was to obtain multidisciplinary expert review of literature to inform both US Government and governments of the low- and middle-income countries on evidence-informed practice, policies, and strategies for financial incentives. Several steps were undertaken to define the tasks for the Summit and identify the appropriate evidence for review. The process began by identifying focal questions intended to inform governments of the low-and middle-income countries and the US Government about the efficacy of supply- and demand-side financial incentives for enhanced provision and use of quality maternal health services. Experts were selected representing the research and programme communities, academia, relevant non-governmental organizations, and government agencies and were assembled into Evidence Review Teams. This was followed by a systematic process to gather relevant peer-reviewed literature that would inform the focal questions. Members of the Evidence Review Teams were invited to add relevant papers not identified in the initial literature review to complete the bibliography. The Evidence Review Teams were asked to comply with a specific evaluation framework for recommendations on practice and policy based on both expert opinion and the quality of the data. Details of the search processes and methods used for screening and quality reviews are described.

Evidence acquisition and evaluation for a U.S. Government Evidence Summit on Protecting Children Outside Family Care.

Recognizing the need for evidence to inform policies, strategies, and programs to care for vulnerable children, the U.S. Government convened an Evidence Summit on Protecting Children Outside of Family Care on December 12-13, 2011, in Washington, DC, USA. This paper summarizes the background and methods for the acquisition and evaluation of the evidence used to achieve the goals of the Summit. A multistep process was undertaken to identify the appropriate evidence for review. It began by identifying crucial focal questions intended to inform low and middle income governments and the U.S. Government about effective systems for protecting children outside family care. This was followed by a systematic attempt to gather relevant peer reviewed and gray literature that would inform these focal questions. The search processes, methods used for screening and quality reviews are described. In addition, members of the Evidence Review Teams were invited to add relevant papers not identified in the initial literature review to complete the bibliographies. These teams were asked to comply with a specific evaluation framework for recommendations on practice and policy based on both expert opinion and the quality of the data. This was the first U.S. Government Evidence Summit originating in the U.S. Agency for International Development Global Health Bureau and valuable lessons were learned on the identification and assessment of evidence informing complex development challenges.

Hijacking of Basic Research: The Case of Synthetic Cannabinoids.

Gathering and communicating knowledge are important aspects of the scientific endeavor. Yet presentation of data in public forums such as scientific meetings and publications makes it available not only to scientists, but also to others who may have different ideas about how to use research findings. A recent example of this type of hijacking is the introduction of synthetic cannabinoids that are sprayed on herbal products and subsequently smoked for their marijuana-like intoxicating properties. Originally developed for the legitimate research purpose of furthering understanding of the cannabinoid system, these synthetic cannabinoids are being abused worldwide, creating issues for regulatory and law enforcement agencies that are struggling to keep up with the growing number of compounds of various structural motifs. Basic and clinical scientists need to provide advice now to facilitate decision-making about the health threats posed by this emerging problem.

Areca nut dependence among chewers in a South Indian community who do not also use tobacco.

AIMS: Previously reported research suggests a dependence syndrome for areca nut use, though well-designed studies are virtually non-existent. The goal of this study was to examine evidence of areca dependence in a sample of areca-only (i.e. no tobacco) chewers using modified measurement scales. DESIGN: A purposive sample of chewers, identified via local informants and advertisements, was surveyed from January to March of 2005. SETTING: Six villages in Dakshina Kannada District, Karnataka State, India. PARTICIPANTS: Fifty-nine daily areca chewers who do not also currently use any form of tobacco. MEASUREMENTS: Questionnaires included modified versions of the Fagerström Tolerance Questionnaire, Cigarette Dependence Scale (CDS-5) and the Smokeless Tobacco Dependence Scale (STDS). Additional questions assessed demographic characteristics and patterns of use. FINDINGS: Approximately half of respondents reported 1-3 chews/day (mean = 1.9; SD = 0.98). The average number of chewing episodes/day was 4.4 (SD = 3.4) and the average number of nuts/day was 1.2 (SD = 1.1). Users' typical chew lasts up to 20 minutes and includes spitting out the juices and rinsing the mouth with water. Overall, the levels of reported dependence symptoms were quite low, but approximately 44% of chewers endorsed at least one of the following items: continued use despite illness or mouth wounds, difficulty refraining from chewing in forbidden places, or craving during periods of abstinence. Approximately 15.4% of chewers reported at least one intentional quit attempt and a subset had summary scores indicative of dependence (13.6% had scores >16 on the CDS-5 and 5.3% had scores >11 on the STDS). Dependence scores were positively correlated with frequency of chews/day. CONCLUSIONS: The symptoms of dependence observed in a subset of areca-only chewers warrant further investigation. Next steps should include well-controlled laboratory evaluation of dependence features.

Risk management and post-marketing surveillance for the abuse of medications acting on the central nervous system: expert panel report.

The abuse and diversion of medications is a significant public health problem. This paper is part of a supplemental issue of Drug and Alcohol Dependence focused on the development of risk management plans and post-marketing surveillance related to minimizing this problem. The issue is based on a conference that was held in October 2008. An Expert Panel was formed to provide a summary of the conclusions and recommendations that emerged from the meeting involving drug abuse experts, regulators and other government agencies, pharmaceutical companies and professional and other non-governmental organizations. This paper provides a written report of this Expert Panel. Eleven conclusions and 11 recommendations emerged concerning the state of the art of this field of research, the regulatory and public health implications and recommendations for future directions. It is concluded that special surveillance tools are needed to detect the emergence of medication abuse in a timely manner and that risk management tools can be implemented to increase the benefit to risk ratio. The scientific basis for both the surveillance and risk management tools is in its infancy, yet progress needs to be made. It is also important that the unintended consequences of increased regulation and the imposition of risk management plans be minimized.

Preclinical evaluation of the abuse potential of the analgesic bicifadine.

The abuse liability of the analgesic bicifadine was investigated in animal models used to predict the abuse potential of psychostimulants in humans. Bicifadine, cocaine, d-amphetamine, bupropion, and desipramine were evaluated for the production of cocaine-like discriminative stimulus effects in rats. Cocaine, d-amphetamine, and bupropion dose-dependently and fully substituted for cocaine. Bicifadine and desipramine produced a maximum mean cocaine-lever selection of 80 and 69%, respectively, but doses yielding peak substitution strongly suppressed response rates. Microdialysis studies in normal waking rats indicated that d-amphetamine increased dopamine levels in the nucleus accumbens and striatum to a much greater degree than bicifadine, but bicifadine increased 5-hydroxytryptamine levels in the nucleus accumbens and striatum more than d-amphetamine. Bicifadine was also tested for intravenous self-administration in rhesus monkeys experienced with cocaine administration. Reinforcing effects of bicifadine were observed in only two of four subjects, whereas cocaine, d-amphetamine, and bupropion served as reinforcers in all four monkeys. When evaluated under a progressive ratio procedure, no dose of bicifadine maintained responding to the extent of cocaine, d-amphetamine, or bupropion. The discriminative stimulus effects associated with bicifadine were similar, but not identical, to those of psychostimulants. Although bicifadine maintained self-administration behavior in some subjects, its reinforcing efficacy was very low relative to cocaine, d-amphetamine, and bupropion. These results are consistent with the microdialysis findings of lower dopamine levels and higher 5-hydroxytryptamine levels after administration of bicifadine relative to d-amphetamine. Overall, the current findings support a low abuse potential of bicifadine, more resembling that of antidepressants than psychostimulants.

The discriminative stimulus effects of N-methyl-D-aspartate glycine-site ligands in NMDA antagonist-trained rats.

RATIONALE: Many N-methyl-D-aspartate (NMDA) antagonists produce phencyclidine (PCP)-like side effects that limit their clinical utility. NMDA glycine-site antagonists may be less likely to produce these effects than other site-selective NMDA antagonists. OBJECTIVES: The objective of the study is to compare the discriminative stimulus effects of novel NMDA glycine-site drugs to those of channel blocking and competitive NMDA antagonists. MATERIALS AND METHODS: Drug discrimination studies were performed in separate groups of rats trained with saline vs. PCP (2 mg/kg i.p.) or the competitive antagonist NPC 17742 (4 mg/kg i.p.) using a standard two-lever operant conditioning procedure under an FR32. RESULTS: Neither the partial glycine-site agonists aminocyclopropane carboxylic acid methyl ester and (+)-HA-966 nor the antagonists L701,324; MDL 100,458; MDL 100,748; MDL 103,371; MDL 104,472; MDL 105,519; MRZ 2/571; MRZ 2/576; and ACEA 0762 produced >50% PCP-lever selection, though all were tested over a sufficient dose range to produce response rate decreasing effects. All of the antagonists, except MDL 100,458 and MDL 100,748, were also tested for NPC 17742-like effects, producing somewhat more variable results than in PCP-trained rats. ACEA-0762 produced full substitution for NPC 17742, whereas MDL 105,519 produced no substitution. The remaining compounds engendered between 20% and 80% drug-lever selection. CONCLUSION: These results provide evidence that NMDA glycine-site partial agonists and antagonists generally do not produce discriminative stimulus effects similar to those of representative NMDA channel blockers or competitive antagonists. This suggests that these NMDA glycine-site antagonists should be less likely to produce the undesirable behavioral side effects seen in clinical trials with many other NMDA antagonists.