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Background: Learning which letters correspond to which speech sounds is fundamental for learning to read. Based on previous experimental studies, we developed a serious game aiming to boost letter‐speech sound (L‐SS) correspondences in a motivational game environment. Objectives: The goal of this study was to determine the efficacy of this game in training L‐SS correspondences in pre‐readers. Additionally, an extended version of the game was developed given the importance of handwriting in audio‐visual integration. We established whether including a motoric component in the game boosted the letter‐speech sound training on top of the effect of the game without the motoric component. Methods: One‐hundred forty‐five kindergartners were randomly allocated to play either the standard audio‐visual version of the game, the motoric version or a control math game. All children were pre‐ and post‐tested on L‐SS knowledge and reading accuracy. Results and conclusions: We found that playing the game enhanced pre‐readers' L‐SS knowledge, but not reading accuracy, after a short, intensive intervention period of 3 weeks. However, children who played the motoric version of the game did not differ significantly from either the standard or the control condition. Implications: This game was efficient in training L‐SS correspondences in pre‐readers. These results suggest that this game might be useful as a preventive evidence‐based intervention for at‐risk children in kindergarten who might benefit from a head start before learning how to read. Future studies are needed to examine whether a longer intervention period results in L‐SS knowledge being translated into reading skills. Lay Description: What is already known about this topic: Automatised and fluent reading requires much exposure and practice, but intensive teacher support for all at‐risk readers is economically and practically unfeasibleHandwriting movement likely to enhance coupling of auditory and visual informationOne way to provide high exposure is with game‐based interventionsLack of studies examining the efficacy of these interventions What this paper adds: Serious game enhances letter‐speech sound knowledge in pre‐readers after 3 weeks of intensive interventionThis effect did not transfer to reading performanceNo additional effect of the handwriting movement, possibly due to the short intervention periodIn‐game measures slightly mediated intervention progress Implications for practice and/or policy: Growing evidence of game‐based interventions as promising tools to support reading developmentGame can possibly serve as evidence‐based intervention for at‐risk children in kindergarten who might benefit from a head start before learning how to read [ABSTRACT FROM AUTHOR]

Background: Leaderboards are a highly popular gamification component used in student learning to enhance motivation, attentional engagement, and learning performance. However, few studies have examined the effects of individual leaderboard elements on English vocabulary learning through video lectures. Objectives: The present study aimed to examine how different leaderboard elements (i.e., points and rank) may affect students' English vocabulary learning through video lectures. Methods: A total of 34 students were assigned to groups using different leaderboard elements in a counterbalanced order. Participants' motivation, eye movements, and learning performance were measured and analysed. Results and Conclusions: Students' leaderboard rank was shown to increase their motivation regardless of whether other elements were present. Eye movement tracking revealed that the presence of the leaderboard increased students' saccades between the questions and the options, and lengthened their dwell time on the learning materials while reducing their dwell time on the non‐learning‐related screen areas. Presenting students' rank alone also improved their learning performance. Implications: Our findings strongly support the use of video lectures for English vocabulary learning, with the following recommendations: (1) Instructors should present students' rank on the leaderboard to enhance students' motivation and engagement; (2) Instructors should present only the students' rank on the leaderboard to also enhance students' learning performance. Lay Description: What is already known about this topic: While learning English vocabulary from video lectures, students might experience low levels of motivation and engagement, and pay less attention to the lectures.Leaderboards are a highly popular gamification component used in student learning to enhance motivation, attentional engagement, and learning performance.It remains unclear which leaderboard elements (i.e., points or rank) contribute most significantly to the effectiveness of the leaderboards. What this paper adds: Leaderboard elements have different effects on English vocabulary learning.The rank on the leaderboard benefited students' motivation and engagement.The rank also enhances students' confidence and learning performance. Implications for practice and/or policy: Instructors should present students' rank on the leaderboard to enhance students' motivation and engagement.Instructors should present only the students' rank on the leaderboard to also enhance students' learning performance. [ABSTRACT FROM AUTHOR]

Virtual reality (VR) can promote design performance, and may generate a high cognitive load and affect creative design thinking as well. In order to examine the effect of VR application on cognitive load and engineering design creativity, this study recruited 81 eighth‐grade students as participants and employed a non‐equivalent‐groups quasi‐experimental design to examine how VR application influences creativity components and creative performance. A creativity component scale (creative motivation, creative thinking, and professional cognition), a measurement of creative performance, and a cognitive load scale were used to collect data. The study also investigated the ability of VR application to predict creativity components and creative performance, using cognitive load as the mediator. The conclusions are as follows: (1) VR application had marked effects on professional cognition and creative motivation but no effect on creative thinking skills. (2) VR application had marked effects on the novelty and usefulness aspects of creative performance, particularly with respect to usefulness. (3) VR application had marked effects on extraneous and germane cognitive load, but no influence on intrinsic cognitive load, and (4) Both VR application and cognitive load were able to predict creativity components and creative performance. Their abilities to predict creative performance approached an acceptable level. Nevertheless, VR application had no effect on general creative thinking skills; therefore, other teaching strategies are needed to strengthen creative thinking. Lay Description: What is already known about this topicVirtual reality (VR) can transmit complex knowledge.Virtual reality (VR) can promote design performance.What this paper addsInfluence of VR application on creativity components and creative performance.Ability of VR application and cognitive load to predict creativity components.Ability of VR application and cognitive load to predict creative performance.Implications for practice and/or policyUsing VR teaching to improve learning effects and creativity in high‐risk, expensive, and inaccessible learning fields.Using VR teaching to practice repeatedly, and facilitate basic understanding of the application. [ABSTRACT FROM AUTHOR]

Migraine has close associations with depression and anxiety. Catastrophizing, an alarmist reaction to pain, has been proposed as one of the mediators in the relationship between headache and emotional distress. However, much experimental evidence is needed to make such a view more validated. The aims of this study are to examine the effects of mood induction on the pain responses and to investigate the role of pain catastrophizing in the relationship between pain and mood amongst a sample of patients with migraine. For this purpose, 60 patients with migraine were recruited from a headache clinic in Tehran-Iran and were randomly assigned into one of three groups: negative mood induced group, positive mood induced group and control group. The following instruments and measures were used in this study: mood induction by presenting different types of films (positive, negative), a computerized cognitive task to elicit pain, Beck Depression Inventory and Pain Catastrophizing Scale. The results showed that while the induction of depressed mood increased the pain intensity, the induction of positive mood reduced it significantly ( p < 0.05). Further analyses revealed that catastrophizing is as a confounding factor in the relationship between pain and mood. Once catastrophizing scores were entered into the analyses as a covariate, the significant effect of mood on the pain intensity reduced. In conclusion, both mood and catastrophizing are important factors in understanding the migraine pain. Clinical implications of these findings are discussed in the paper. Copyright © 2014 John Wiley & Sons, Ltd. Key Practitioner Message Pain-related catastrophizing and mood induction are important factors in understanding pain intensity amongst patients with migraine pain., Catastrophizing as a confounding factor in the relationship between pain and mood may partially mediate the relationship between mood and pain., Therapeutic interventions should focus on the reduction of depression and catastrophizing. [ABSTRACT FROM AUTHOR]

Aims This study examines the preliminary outcomes of an intervention targeting service providers in methadone maintenance therapy ( MMT) clinics in China. The intervention effects on both service providers and clients are reported. Design The MMT CARE intervention pilot was developed and implemented collaboratively with local health educators. After three group intervention sessions, trained providers in intervention clinics delivered two individual motivational interviewing sessions with their clients. Settings Six clinics in Sichuan, China, were randomized to either the MMT CARE intervention condition or a standard care condition. Participants A total of 41 providers and 179 clients were sampled from the six clinics. Measurements At baseline and three-, six-, and nine-month assessments, providers completed self-administrated paper/pencil questionnaires regarding provider-client interaction, MMT knowledge, perceived job-related stigma and clinic support. Clients completed a face-to-face survey about their concurrent drug use and drug avoidance self-efficacy. Mixed-effects regression models with clinic-level random effect were used to assess the intervention effects. Findings Significant intervention effects for providers were found in improved MMT knowledge, provider-client interaction and perceived clinic support. For clients, better improvements in drug avoidance self-efficacy and reduced concurrent drug use were observed for the intervention compared with the standard care group. Conclusions The MMT CARE intervention targeting providers in methadone maintenance clinics can improve providers' treatment knowledge and their interaction with clients. The intervention can also reduce clients' drug-using behavior through motivational interviewing sessions conducted by trained providers. [ABSTRACT FROM AUTHOR]

Objectives: To determine the efficacy of four different oral hygiene protocols involving adjunctive interdental devices in terms of plaque and bleeding scores in periodontitis‐affected patients. Material and methods: This was a randomized clinical trial with a 5‐week follow‐up, including previously treated periodontitis patients not undergoing any supportive care. Patients were randomly allocated to 4 groups: manual toothbrush (group TB); toothbrush plus dental floss (group TB/F); toothbrush plus interdental brushes (group TB/IDB) and toothbrush plus rubber interdental picks (group TB/RIDB). Oral hygiene instructions (OHI) were provided at baseline (T‐7) and at T0 (1‐week) then bi‐weekly (T14/T28). At T0, supragingival professional cleaning was delivered. Plaque and bleeding indexes were taken at all timepoints by a single calibrated examiner, blind to group allocation. Results: At T‐7, patients were comparable for age, body mass index (BMI) and all clinical parameters, exceptions for the Interdental Angulated Bleeding Index. At T28, significant reductions of plaque and gingival inflammation were noted in all groups (p < 0.001) and within the expected ranges. Intergroup comparisons identified that group TB/IDB and group TB/RIDB achieved lower levels of plaque and inflammation than group TB (p < 0.05). Group TB/IDB and group TB/RIDB showed lower levels of plaque and lower inflammation as measured by angulated bleeding index than group TB/RIDB (p < 0.05). Conclusion: Interdental brushes and rubber interdental picks were more efficient than toothbrushing alone and toothbrushing and floss in reducing plaque and gingival inflammation measured in a periodontitis‐affected population. [ABSTRACT FROM AUTHOR]

Aim To investigate the clinical and microbiological effects of local disinfection with 0.5% sodium hypochlorite (NaOCl) with or without systemic antimicrobials (amoxicillin and metronidazole, AM) during basic periodontal therapy (BPT). Material and Methods In a randomized clinical trial (four groups), 110 chronic periodontitis patients received BPT plus local irrigation with saline (BPT + S), local disinfection with NaOCl (BPT + DIS), BPT + DIS + AM or BPT + S + AM. The outcome was analysed at baseline, 3, 6 and 12 months. Results There was no difference in clinical attachment level gain at 12 months between the four groups. BPT + DIS showed no additional improvement compared to BPT + S; BPT + DIS + AM showed fewer sites with probing pocket depth (PPD) ≥7 mm versus BPT + S only up to 6 months ( p = 0.037). In factorial analyses, additional clinical reduction for PPD ( p = 0.023) and number of sites with PPD ≥5 ( p = 0.007), ≥6 ( p = 0.002) and ≥7 mm ( p < 0.001) were found when AM was added to BPT, but not when DIS was applied. In all groups, a comparable decrease in targeted bacteria was found. AM caused adverse events in 22% of the patients. Conclusion Local disinfection with NaOCl, also in combination with AM, showed, after 1-year follow-up, no additional clinical and microbiological effects compared to BPT alone. [ABSTRACT FROM AUTHOR]

Objectives To compare the use of sonic powered or manual toothbrush in patients with intellectual disability ( ID) in terms of plaque (PlI) and gingival ( GI) indices and adverse effects. Material and Methods Subjects with ID were recruited for this cluster-randomized, single blinded (examiner), 6-month clinical trial, comparing powered versus manual toothbrushing. Outcome variables included PlI and GI, evaluated at baseline and 3 months after supervised toothbrushing and after 3 additional months of unsupervised used. Clinical outcome variables were analysed by repeated measures ANCOVA considering time and group as factors and respective baseline values as covariates (generalized linear model). Results Sixty-four patients (34 male, mean age 34.5) in six clusters were included in the study. No statistically significant effect of toothbrushing group was observed for PlI or GI. A significant effect of time was identified ( p < 0.001) with mean reductions ranging 0.44-0.45 for PlI and 0.30-0.36 for GI from baseline to 3-6 months. No relevant adverse effect or technical problems were observed. Conclusion The tested sonic powered toothbrush was as effective and safe as the manual toothbrush. The use of powered or manual toothbrushes, together with fluoride toothpaste, may improve plaque and gingivitis levels, in patients with mild to limit ID. [ABSTRACT FROM AUTHOR]

Dialectical behaviour therapy (DBT)-informed skills training for borderline personality disorder (BPD) aims at the development of specific emotion regulation skills in patients, particularly with regard to the regulation of problematic anger. While the effects of dialectical behaviour skills training have been shown, their processes of change are rarely examined. Neacsiu, Rizvi and Linehan (2010) found that patient's self-reported use of emotion regulation skills was a mediator of therapeutic change in these treatments; however, they found no effect for problematic anger. From an integrative perspective on anger (Pascual-Leone & Greenberg, 2007; Pascual-Leone & Paivio, 2013), there are several forms of anger, varying in their degree of therapeutic productivity. The present add-on randomized controlled trial included n = 41 patients with BPD ( n = 21 DBT-informed skills training versus n = 20 treatment as usual). The first study examined the outcome of the DBT-informed skills training encompassing basic components of training in mindfulness, distress tolerance, interpersonal effectiveness and emotion regulation. Results showed that symptom reduction was significantly greater in the DBT-informed skills training, compared with the treatment as usual. The second study used process assessment, for which all patient completers underwent a 50-min-long psychological interview both early and late in treatment, which was rated using the Classification of Affective Meaning States. DBT-informed skills training produced increased levels of primary 'assertive' anger, as compared with the treatment as usual, whereas no effect was found for 'rejecting' secondary anger. Most importantly, we showed that changes in assertive anger mediated the reported symptom reduction, in particular in patient's social roles. We discuss these results in the context of underlying mechanisms of change in DBT skills group treatments, in particular towards developing more productive forms of anger in this patient population. Copyright © 2015 John Wiley & Sons, Ltd. Key Practitioner Message A 20-session dialectical behaviour therapy (DBT)-informed skills training is a promising adjunct intervention for patients with borderline personality disorder, in particular for reducing problems related to social role., Increases in assertive anger mediate the effects of DBT-informed skills training, whereas rejecting anger remains unchanged over the course of treatment., Short-term objectives for intervention might involve the specific increase of assertive anger in BPD, by using DBT-informed skills training; long-term objectives for intervention might involve a specific decrease of rejecting anger in BPD. [ABSTRACT FROM AUTHOR]

Background An increased plasma lipopolysaccharide ( LPS) concentration may favour metabolic disorders such as insulin resistance. The meal composition influences plasma LPS concentrations. The present study aimed to investigate the effect of the acute consumption of a high-fat meal (49% of energy from fat) containing conventional or high-oleic peanuts on post-prandial LPS concentrations and its relationship with lipaemia and insulinaemia in overweight and obese men. Methods The test meal consisted of a shake containing conventional peanuts ( CVP; n = 21), high-oleic peanuts ( HOP; n = 23) or a control biscuit ( CT; n = 21). Blood samples were collected in the fasting state and 1, 2 and 3 h post-prandially. LPS, insulin, lipids and glucose concentrations were assessed. Results LPS concentrations were lower in CVP [mean (SE) 0.7 (0.5) EU mL−1] and HOP [1.0 (0.9) EU mL−1] groups compared to CT [1.6 (1.2) EU mL−1] at 3 h post-prandially. Triacylglycerol and insulin concentrations increased in all groups. Triacylglycerol started to increase only after 2 h in the CVP and HOP groups. LPS correlated positively with triacylglycerol. Insulin returned to basal concentrations at 3 h only in the CVP and HOP groups. Conclusions The acute consumption of peanuts delayed the increase in serum triacylglycerol and favoured the quicker return of insulin to basal concentrations, especially in the CVP group. Our results suggest that the consumption of conventional or high-oleic peanuts may help to reduce the risk of endotoxaemia and metabolic disorders. [ABSTRACT FROM AUTHOR]

Anaemia affects 46% of preschool‐aged children in Nepal. A cluster‐randomised study was conducted in rural Nepal to test whether providing micronutrient powders (MNP) in addition to enhanced homestead food production (EHFP) programme, consisting of home gardens, poultry and nutrition education, could lead to a higher reduction in anaemia compared with providing only EHFP. This sub‐study enrolled 335 children aged 6–9 months into one of three groups: (1) EHFP + MNP; (2) EHFP; or (3) control. The EHFP + MNP group received 60 sachets of MNP for flexible consumption at the start and 6 months later for a total supplementation period of 11 months. The MNP contained 15 micronutrients including iron (10 mg encapsulated ferrous fumarate). Haemoglobin and anthropometry were measured at baseline and post‐MNP supplementation. Mean ± SE haemoglobin concentration increased significantly in all groups, with a slightly higher but non‐significant increase in the EHFP + MNP and EHFP compared with control (difference‐in‐differences: 4.1 g L−1 for EHFP + MNP vs. control; 3.6 g L−1 for EHFP vs. control; 0.5 g L−1 for EHFP + MNP vs. EHFP). Anaemia decreased at a slightly higher magnitude in the EHFP + MNP [51.5 percentage points (PP)] than the EHFP (48.6 PP) and control (39.6 PP), with adjusted odds ratios (95% CI) at post‐supplementation of 0.52 (0.25–1.12) for EHFP + MNP and 0.69 (0.35–1.36) for EHFP, compared with control. There was no impact on child growth. Combining EHFP and MNP programmes yielded a marginally significant reduction in anaemia among children. [ABSTRACT FROM AUTHOR]

Aims To examine the effectiveness of a personality-targeted intervention program (Adventure trial) delivered by trained teachers to high-risk (HR) high-school students on reducing marijuana use and frequency of use. Design A cluster-randomized controlled trial. Setting Secondary schools in London, UK. Participants Twenty-one secondary schools were randomized to intervention ( n = 12) or control ( n = 9) conditions, encompassing a total of 1038 HR students in the ninth grade [mean (standard deviation) age = 13.7 (0.33) years]. Interventions Brief personality-targeted interventions to students with one of four HR profiles: anxiety sensitivity, hopelessness, impulsivity and sensation-seeking. Measurements Primary outcome: marijuana use. Secondary outcome: frequency of use. Assessed using the Reckless Behaviour Questionnaire at intervals of 6 months for 2 years. Personality risk was measured with the Substance Use Risk Profile Scale. Findings Logistic regression analysis revealed significant intervention effects on cannabis use rates at the 6-month follow-up in the intent-to-treat sample [odds ratio (OR) = 0.67, P = 0.05, 95% confidence interval (CI) = 0.45-1.0] and significant reductions in frequency of use at 12- and 18-month follow-up (β = -0.14, P ≤ 0.05, 95% CI = -0.6 to -0.01; β = -0.12, P ≤ 0.05, 95% CI = -0.54 to 0.0), but this was not supported in two-part latent growth models. Subgroup analyses (both logistic and two-part models) reveal that the sensation-seeking intervention delayed the onset of cannabis use among sensation seekers (OR = 0.25, β = -0.833, standard error = 0.342, P = 0.015). Conclusions Personality-targeted interventions can be delivered effectively by trained school staff to delay marijuana use onset among a subset of high-risk teenagers: sensation-seekers. [ABSTRACT FROM AUTHOR]

To analyze the effects of an intervention focused on increasing the time and intensity of Physical Education ( PE), on adolescents' cognitive performance and academic achievement. A 4-month group-randomized controlled trial was conducted in 67 adolescents from South- East Spain, 2007. Three classes were randomly allocated into control group ( CG), experimental group 1 ( EG1) and experimental group 2 ( EG2). CG received usual PE (two sessions/week), EG1 received four PE sessions/week and EG2 received four PE sessions/week of high intensity. Cognitive performance (non-verbal and verbal ability, abstract reasoning, spatial ability, verbal reasoning and numerical ability) was assessed by the Spanish Overall and Factorial Intelligence Test, and academic achievement by school grades. All the cognitive performance variables, except verbal reasoning, increased more in EG2 than in CG (all P < 0.05). Average school grades (e.g., mathematics) increased more in EG2 than in CG. Overall, EG2 improved more than EG1, without differences between EG1 and CG. Increased PE can benefit cognitive performance and academic achievement. This study contributes to the current knowledge by suggesting that the intensity of PE sessions might play a role in the positive effect of physical activity on cognition and academic success. Future studies involving larger sample sizes should confirm or contrast these preliminary findings. [ABSTRACT FROM AUTHOR]

Background Modifying the consistency of food and drink is a strategy commonly used in the management of dysphagia for people with intellectual disabilities ( ID). People with ID often depend on others for the preparation of food and drink and therefore depend on those caregivers achieving the correct consistency to keep them safe and avoid discomfort during mealtimes. Clinical experience and prior research have demonstrated that although training can improve modification, carers often find modification difficult and potentially stressful and recommend additional support for carers. Fluid consistency is often modified through the addition of powdered thickener. This study investigates the efficacy of typical training and use of consistency guides, the Thickness Indicator Model ( TIM) tubes, in helping carers to modify fluids accurately. Method A 3 × 3 pre-post experimental design with a control group was employed to compare the observed accuracy of modification across three groups and at three time points (pre-intervention baseline, immediately post-training intervention and 3-10 months post-training). Sixty-two paid carers who supported people with ID were recruited to participate in the study and each was randomly allocated to one of the three groups: a control group given written guidance only, a group who received typical training and written guidance and a group who received training, written guidance and the TIM tubes. Results & Conclusions Typical training resulted in significantly greater carer accuracy in modifying fluid consistencies when compared with written guidance alone. Use of the TIM tubes also significantly improved accuracy in the modification of drinks compared with the group who modified with the aid of written guidance alone. At 3-10-month follow-up only the group who received typical training alongside the TIM tubes were significantly more accurate than the Written Guidance group. Further research is warranted to ascertain the effectiveness of the training and the utility of the TIM tubes in improving accuracy over a longer time scale and in individuals' usual living environments. [ABSTRACT FROM AUTHOR]

Aim Investigate short-term effects of power brushing following experimental induction of biofilm overgrowth in periodontal disease states. Materials and Methods Overall, 175 subjects representing each of five biofilm-gingival interface ( BGI) periodontal groups were enrolled in a single-blind, randomized study. After stent-induced biofilm overgrowth for 21 days subjects received either a manual or a power toothbrush to use during a 4 weeks resolution phase. At baseline and during induction and resolution, standard clinical parameters were measured. Subclinical parameters included multikine analysis of 13 salivary biomarkers and 16s Human Oral Microbe Identification Microarray ( HOMIM) probe analysis of subgingival plaque samples. Results All groups exhibited significantly greater reductions in bleeding on probing ( BOP) ( p = 0.002), gingival index ( GI) ( p = 0.0007), pocket depth ( PD) ( p = 0.04) and plaque index ( p = 0.001) with power brushing compared to manual. When BGI groups were combined to form a shallow PD ( PD ≤ 3 mm) and a deep PD group ( PD > 4 mm) power brushing reduced BOP and GI in subjects with both pocket depths. Power brushing significantly reduced IL-1β levels at resolution while changes in bacterial levels showed non-significant trends between both brushing modalities. Conclusions Short-term changes in select clinical parameters and subclinical salivary biomarkers may be useful in assessing efficacy of power brushing interventions in a spectrum of periodontal disease states. [ABSTRACT FROM AUTHOR]

Aim To determine pre- and post-dosing effects of prenatal methadone compared to buprenorphine on fetal wellbeing. Design A secondary analysis of data derived from the Maternal Opioid Treatment: Human Experimental Research ( MOTHER) study, a double-blind, double-dummy, randomized clinical trial. Setting Six United States sites and one European site that provided comprehensive opioid-dependence treatment to pregnant women. Participants Eighty-one of the 131 opioid-dependent pregnant women completing the MOTHER clinical trial, assessed between 31 and 33 weeks of gestation. Measurements Two fetal assessments were conducted, once before and once after study medication dosing. Measures included mean fetal heart rate ( FHR), number of FHR accelerations, FHR reactivity in the fetal non-stress test ( NST) and biophysical profile ( BPP) score. Findings Significant group differences were found for number of FHR accelerations, non-reactive NST and BPP scores (all Ps < 0.05). There were no significant group differences before time of dosing. Significant decreases (all Ps < 0.05) occurred from pre- to post-dose assessment for mean FHR, FHR accelerations, reactive NST and fetal movement. The decrease in accelerations and reactive NST were significant only for fetuses in the methadone group, and this resulted in a significantly lower likelihood of a reactive NST compared to fetuses in the buprenorphine group. Conclusion Buprenorphine compared with methadone appears to result in less suppression of mean fetal heart rate, fetal heart rate reactivity and the biophysical profile score after medication dosing and these findings provide support for the relative safety of buprenorphine when fetal indices are considered as part of the complete risk-benefit ratio. [ABSTRACT FROM AUTHOR]

Endogenous opioids and µ-opioid receptors have been linked to hedonic and rewarding aspects of palatable food intake. The authors examined the safety, pharmacokinetic, and pharmacodynamic profile of GSK1521498, a µ-opioid receptor inverse agonist that is being investigated primarily for the treatment of overeating behavior in obesity. In healthy participants, GSK1521498 oral solution and capsule formulations were well tolerated up to a dose of 100 mg. After single doses (10-150 mg), the maximum concentration (Cmax) and area under the curve (AUC) in plasma increased in a dose-proportional manner. GSK1521498 selectively reduced sensory hedonic ratings of high-sugar and high-fat dairy products and caloric intake of high-fat/high-sucrose snack foods. These findings provide encouraging data in support of the development of GSK1521498 for the treatment of disorders of maladaptive ingestive behavior or compulsive consumption. [ABSTRACT FROM PUBLISHER]

Recent reports indicate an increase in intranasal use of prescription oral stimulant medication. However, there do not appear to be any published clinical studies that have characterized the behavioral and cardiovascular effects of intranasally administered d-amphetamine, which is commonly prescribed for Attention Deficit Hyperactivity Disorder. In this study, a range of d-amphetamine doses (0, 16, 24, and 32 mg/70 kg) were administered as an intranasal solution delivered using a mucosal atomization device. Equal oral doses were included for comparison. Assessments were conducted before and at regular intervals for 3 hours following drug administration and included self-reported drug-effect questionnaires, cardiovascular indices, a performance task, and 2 measures of impulsivity. d-Amphetamine produced prototypical stimulant effects (eg, increased subject ratings of Stimulated and Like Drug, elevated heart rate and blood pressure, and improved rate and accuracy on the digit symbol substitution task) irrespective of dose, but the onset of these effects was generally earlier following intranasal administration, with significant effects emerging 15 to 30 minutes after intranasal dosing and 45 to 60 minutes after oral dosing. These results demonstrate that intranasal administration of d-amphetamine results in a more rapid onset compared to oral dosing, which could be associated with the popularity of intranasal prescription stimulant use and an enhanced potential for abuse. [ABSTRACT FROM PUBLISHER]

To determine the effect of offering smokers who want to quit easy access to nicotine replacement therapy (NRT), a period of familiarization and choice of product on smoking abstinence at 6 months. Single-blind, randomized controlled trial. New Zealand. A total of 1410 adult smokers who called the national Quitline for quitting support were randomized to usual Quitline care or a box containing different NRT products (patch, gum, inhaler, sublingual tablet, oral pouch) to try for a week prior to quitting, and then to choose one or two of these products for 8 weeks' use. The primary outcome was 7-day point prevalence smoking abstinence 6 months after quit day. Secondary outcomes included continuous abstinence, cigarette consumption, withdrawal, NRT choice and serious adverse events at 1 and 3 weeks and 3 and 6 months. No differences in 6-month quit rates (7-day point prevalence or continuous abstinence) were observed between the groups. However, smokers allocated to the intervention group were more likely to have quit smoking at 3 months [self-reported point prevalence, relative risk (RR) = 1.17, 95% confidence interval (CI): 1.02, 1.35, P = 0.03], had a longer time to relapse (median 70 days versus 28 days, P < 0.01) and used significantly more NRT. The selection box concept was highly acceptable to users, with the patch and inhaler combination the most popular choice (34%). In terms of smoking abstinence at 6 months, offering smokers who want to quit free access to a wide range of nicotine replacement therapy, including a 1-week period of familiarization and choice of up to two products, appears no different to offering reduced cost and choice of nicotine replacement therapy, with no familiarization period. [ABSTRACT FROM AUTHOR]