Effects of Thai Local Ingredient Odorants, Litsea cubeba and Garlic Essential Oils, on Brainwaves and Moods.

The functional food market is growing with a compound annual growth rate of 7.9%. Thai food recipes use several kinds of herbs. Lemongrass, garlic, and turmeric are ingredients used in Thai curry paste. Essential oils released in the preparation step create the flavor and fragrance of the famous tom yum and massaman dishes. While the biological activities of these ingredients have been investigated, including the antioxidant, anti-inflammatory, and antimicrobial activities, there is still a lack of understanding regarding the responses to the essential oils of these plants. To investigate the effects of essential oil inhalation on the brain and mood responses, electroencephalography was carried out during the non-task resting state, and self-assessment of the mood state was performed. The essential oils were prepared in several dilutions in the range of the supra-threshold level. The results show that Litsea cubeba oil inhalation showed a sedative effect, observed from alpha and beta wave power reductions. The frontal and temporal regions of the brain were involved in the wave alterations. Garlic oil increased the alpha wave power at lower concentrations; however, a sedative effect was also observed at higher concentrations. Lower dilution oil induced changes in the fast alpha activity in the frontal region. The alpha and beta wave powers were decreased with higher dilution oils, particularly in the temporal, parietal, and occipital regions. Both Litsea cubeba and turmeric oils resulted in better positive moods than garlic oil. Garlic oil caused more negative moods than the others. The psychophysiological activities and the related brain functions require further investigation. The knowledge obtained from this study may be used to design functional food products.

Self-blinding citizen science to explore psychedelic microdosing.

Microdosing is the practice of regularly using low doses of psychedelic drugs. Anecdotal reports suggest that microdosing enhances well-being and cognition; however, such accounts are potentially biased by the placebo effect. This study used a 'self-blinding' citizen science initiative, where participants were given online instructions on how to incorporate placebo control into their microdosing routine without clinical supervision. The study was completed by 191 participants, making it the largest placebo-controlled trial on psychedelics to-date. All psychological outcomes improved significantly from baseline to after the 4 weeks long dose period for the microdose group; however, the placebo group also improved and no significant between-groups differences were observed. Acute (emotional state, drug intensity, mood, energy, and creativity) and post-acute (anxiety) scales showed small, but significant microdose vs. placebo differences; however, these results can be explained by participants breaking blind. The findings suggest that anecdotal benefits of microdosing can be explained by the placebo effect.

Psychedelic psychotherapy, therapy enhanced with psychedelic drugs such as LSD or psilocybin (the active ingredient of 'magic mushrooms'), has been suggested to improve psychological well-being. For this reason, trials on psychedelic therapy for the treatment of depression, addiction and other conditions are ongoing. Recently, 'microdosing' ­ a way of administering psychedelics that involves taking about 10% of a recreational dose two or three times per week ­ has gained popularity. Unlike taking large doses of psychedelics, microdosing does not induce hallucinations, but anecdotal reports suggest that it yields similar benefits as psychedelic therapy. A key feature of modern medicine are 'placebo control' studies that compare two groups of patients: one that takes a drug and another that takes inactive pills, known as placebos. Crucially, neither group knows whether they are taking drug or placebo. This control ensures that observed effects are due to the drug itself and not to unrelated psychological causes. For example, in trials of mood medicines, participants often expect to feel happier, which in itself improves their mood even when taking a placebo. This is known as the placebo effect. Restrictive drug policies make placebo-controlled studies on psychedelics difficult and expensive, in particular for microdosing, which involves taking psychedelics over a longer time period. To overcome this problem, Szigeti et al. developed a new citizen-science approach, where microdosers implemented their own placebo control based on online instructions. The advantages are the low cost and the ability to recruit participants globally. The experiment was completed by 191 microdosers, making it the largest placebo-controlled study on psychedelics to-date, for a fraction of the cost of an equivalent clinical study. The trial examined whether psychedelic microdosing can improve cognitive function and psychological well-being. The team found that microdosing significantly increased a number of psychological measures, such as well-being and life satisfaction. However, participants taking placebo also improved: there were no significant differences between the two groups. The findings confirmed positive anecdotes about microdosing improving people's moods, but at the same time show that taking empty capsules, knowing they might be microdoses, have the same benefits. This result suggests that the observed benefits are not caused by the microdose, but rather by psychological expectations. The study's innovative 'do-it-yourself' approach to placebo control may serve as a template for future citizen science studies on other popular phenomena where positive expectations and social factors could play a role, such as cannabidiol (CBD) oils, nootropics and nutrition.

Depressive Symptoms in Stroke Patients: Are There Sex Differences?

BACKGROUND: We aimed to examine sex differences in symptom characteristics and pharmacological responses in post-stroke depressive (PSD) symptoms. METHODS: This is a post hoc analysis of EMOTION (ClinicalTrials.gov, NCT01278498), a randomized, placebo-controlled, double-blind trial that examined the efficacy of escitalopram for 3 months on depression in patients with acute stroke. Depressive symptoms were evaluated using the 10-item Montgomery-Åsberg Depression Rating Scale (MADRS). Baseline characteristics, clinical variables, and treatment responses to escitalopram were compared between male and female patients. Treatment responses were defined as changes in MADRS (total score and its components) between baseline and 3 months and were compared between the escitalopram and placebo groups within each sex group. The least square mean was calculated to determine the independent effect of escitalopram, of which interaction was evaluated with patient sex. RESULTS: Of the 478 patients (intention-to-treat population), 187 (39%) were female. Female patients were significantly older than male patients and demonstrated more severe depressive symptoms at baseline (male vs. female, MADRS score, mean [SD]: 9.7 ± 8.0 vs. 12.2 ± 8.4, p = 0.001), especially in apparent sadness, reported sadness, and reduced appetite items. These differences were significant after adjustment for age and the severity of neurologic deficits. The female escitalopram group showed a significant 3-month improvement in MADRS scores (placebo [n = 86] vs. escitalopram [n = 101], least square mean [95% CI] -2.7 [-4.1 to -1.2] vs. -5.0 [-6.4 to -3.6], p = 0.007), and this efficacy was prominent in apparent sadness, reported sadness, and pessimistic thoughts items. However, there was no significant effect of escitalopram on depressive symptoms in the male group. The treatment responses of escitalopram tended to be more pronounced in the female group, particularly in alleviating a subset of depressive symptoms such as apparent sadness (p for interaction = 0.009). CONCLUSION: PSD may differ according to sex in its symptom characteristics and treatment responses to escitalopram, and tailored treatment strategies for PSD may therefore be needed.

Assessment of the Progression of Poststroke Depression in Ischemic Stroke Patients Using the Patient Health Questionnaire-9.

BACKGROUND: Poststroke depression (PSD) affects one-third of stroke patients and is linked with higher stroke morbidity, mortality, and recurrence. Current guidelines do not direct when to screen for PSD, and predictors of PSD are not well understood. We sought to understand progression of PSD symptoms early after ischemic stroke, identify predictors of PSD, and describe the use of antidepressants in PSD. METHODS: We collected demographic, clinical, and PSD (Patient Health Questionnaire-9; PHQ-9) data from ischemic stroke patients hospitalized at our Comprehensive Stroke Center and followed up in our clinic. PHQ-9 was obtained during hospitalization and again in clinic within 180 days of discharge. We performed univariate analysis and logistic regression to detect variables associated with PSD. RESULTS: Among 201 patients, PSD symptoms (PHQ-9 > 4) were identified in 30% of patients during hospitalization and 46% during follow-up (54% of which had no symptoms during hospitalization). At follow-up, 36% were worse by PHQ-9 category. In univariate analysis, follow-up modified Rankin Scale (mRS) greater than or equal to 2 (P = .03) and antidepressant prescription (P < .001) were associated with worsening PHQ-9 category. In logistic regression analysis, follow-up mRS greater than or equal to 2 (P = .02), posterior circulation stroke (P = .03), and antidepressant prescription (P < .01) were associated with worsening PHQ-9 category. CONCLUSIONS: Almost half of ischemic stroke patients develop PSD symptoms and more than one-third worsen between hospitalization and follow-up. Poststroke disability (mRS ≥ 2) and posterior circulation stroke were associated with worsening PSD. Worsening PSD symptoms prompted treatment change in 29% of patients. Screening for PSD during hospitalization should be repeated during early follow-up.

The Effectiveness and Value of Esketamine for the Management of Treatment-Resistant Depression.

DISCLOSURES: Funding for this summary was contributed by the Laura and John Arnold Foundation, National Institute for Health Care Management, California Health Care Foundation, Blue Cross Blue Shield of Massachusetts, Harvard Pilgrim Healthcare, and Kaiser Foundation Health Plan to the Institute for Clinical and Economic Review (ICER), an independent organization that evaluates the evidence on the value of health care interventions. ICER's annual policy summit is supported by dues from Aetna, America's Health Insurance Plans, Anthem, AstraZeneca, Allergan, Alnylam, Biogen, Blue Shield of California, Cambia Health Services, CVS Caremark, Editas, Express Scripts, Genentech, GlaxoSmithKline, Harvard Pilgrim Health Care, Health Care Service Corporation, HealthPartners, HealthFirst, Johnson & Johnson (Janssen), Kaiser Permanente, LEO Pharma, Mallinkrodt Pharmaceuticals, Merck, Novartis, National Pharmaceutical Council, Premera, Prime Therapeutics, Regeneron, Sanofi, Spark Therapeutics, and United Healthcare. Agboola, Fazioli, and Pearson are employed by ICER. Touchette reports grants from ICER during the course of this work and personal fees from Monument Analytics, unrelated to this work. Atlas has nothing to disclose.

Dissociating the Clinical Role and Economic Value of Intranasal Esketamine.

DISCLOSURES: No funding supported the writing of this commentary. The author has nothing to disclose.

Flavored cigar smoking among African American young adult dual users: An ecological momentary assessment.

BACKGROUND: Flavored cigar sales have increased in recent years in the U.S. African American young adults (AAYAs) have high prevalence of smoking flavored cigars and dual use with cigarettes, but the predictors of use are unclear. We examined the predictors of flavored cigar smoking among AAYA dual users. METHODS: We analyzed data from an Ecological Momentary Assessment (EMA) study that captured near real-time affect, smoking cues, and tobacco smoking from eight text-messaging surveys per day over two weeks. Sixty-three AAYA (ages 18-29) dual users of cigarettes and cigars recorded 1205 cigar smoking moments. Multivariable Generalized Estimating Equations were used to assess the predictors of smoking cigars with flavors and specific flavor types. RESULTS: Half of the participants were women (49.2%) and aged between 18-24 (46.7%). Over the two-weeks, almost all (98.4%) participants smoked flavored cigars, and 64.2% of the cigars smoked were flavored. Alcohol (34.4%) was the most frequently smoked flavor type followed by sweet (23.4%) and mint (5.7%). Feeling stressed (AOR = 1.07) and bored (AOR = 1.10) predicted smoking alcohol flavors. Blunt smoking positively predicted smoking sweet flavors (AOR = 4.79), but negatively predicted smoking alcohol flavors (AOR = 0.40). CONCLUSIONS: Smoking flavored cigars, especially alcohol-flavored cigars, was prevalent among AAYA dual users in this study. This group might use specific flavors for different purposes including smoking blunts and boosting mood. Efforts to reduce cigar use need to tackle these risk factors and the increased marketing and low-cost pricing of cigars. A federal ban of cigar flavors might reduce the appeal of cigar products.

Developing a laboratory model of smoking lapse targeting stress and brief nicotine deprivation.

Stress plays a significant role in the maintenance of, and relapse to, smoking. The current study aims to develop a human laboratory model examining stress-precipitated tobacco lapse following brief nicotine deprivation. Daily smokers (N = 48; 50% female) who were nicotine deprived for 3 hr received a personalized imagery induction (stress or neutral, within-subject, counterbalanced) on 2 separate days. Following imagery induction, participants were instructed that they could smoke or receive monetary reinforcement ($0.25, $0.50, $1.00; between-subjects) for every 5 min they chose to delay tobacco self-administration during a 50-min delay period. After the delay period, participants engaged in a 1-hr ad libitum smoking period. Tobacco craving and mood were assessed throughout. The primary aim was to determine whether stress imagery would reduce the ability to resist following a brief nicotine deprivation in a laboratory setting. A secondary goal identified which level of monetary reinforcement highlighted the effect of stress on reduced ability to resist smoking (i.e., resisting ∼25 min of the 50-min window). Overall, stress versus neutral imagery decreased the ability to resist smoking, increased craving and negative mood states, decreased positive mood, but did not change ad libitum smoking. Increased monetary reinforcement increased the ability to resist smoking. Planned comparisons examining lapse behavior within each monetary condition demonstrated that $0.50 produced the only significant difference between stress and neutral imagery, demonstrating target model behavior. Findings highlight that stress negatively impacts smoking lapse behavior and can be effectively modeled in the human laboratory with a brief, 3-hr deprivation window. (PsycINFO Database Record

Using ecological momentary assessment to examine the relationship between craving and affect with opioid use in a clinical trial of clonidine as an adjunct medication to buprenorphine treatment.

BACKGROUND: In a recent clinical trial (NCT00295308), we demonstrated that clonidine decreased the association between opioid craving and moderate levels of stress and affect in patients receiving buprenorphine-based opioid agonist therapy. OBJECTIVES: To examine the relationship between illicit opioid use and craving and affect during the evaluation of clonidine as an adjunct medication in buprenorphine treatment for opioid use disorder. Secondarily, to examine whether those relationships are driven by within- or between-participant factors. METHODS: This was a secondary data analysis from our original trial. Participants (N = 108, female: n = 23, male n = 85) receiving buprenorphine were randomized to receive adjunct clonidine or placebo. Participants used portable electronic devices to rate stress, mood, and craving via ecological momentary assessment (EMA) four times randomly each day. To associate the EMA data with illicit opioid use, each EMA report was linked to participants' next urine drug screen (thrice weekly). We used generalized linear mixed models to examine the interaction between treatment group and illicit opioid use, as well as to decompose the analysis into within- and between-participant effects. RESULTS: Craving for opioids and cocaine was increased when participants were using illicit opioids; this effect was greater in the clonidine group. For affect, mood was poorer during periods preceding opioid-positive urines than opioid-negative urines for clonidine-treated participants, whereas there was no difference for placebo participants. CONCLUSION: This secondary analysis provides evidence that for participants maintained on opioid agonist therapy, clonidine minimized the behavioral impact of moderate levels of negative affect and craving.

An assessment of concurrent cannabidiol and Δ9-tetrahydrocannabinol administration in place aversion and taste avoidance conditioning.

Rising interest in medical marijuana has prompted research into its phytocannabinoid constituents, particularly Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Coadministration of CBD with THC has been shown to modulate a number of THC's effects, including its negative stimulus properties (e.g., anxiety, paranoia, psychosis) in a clinical setting. The present series of experiments extended these analyses by examining the ability of CBD to impact the aversive effects of THC as assessed in a combined taste and place conditioning procedure. In Experiment 1, male and female Wistar rats were given access to a novel saccharin solution, injected with a vehicle solution CBD (0.075, 0.75 mg/kg), THC (0.75 mg/kg) or several combinations of CBD and THC (1:10 or 1:1 dose ratio), and then placed in a distinct chamber of a place conditioning apparatus. When THC was administered alone, it induced significant place aversions and taste avoidance. At both dose ratios, CBD failed to modulate either effect. There were no sex differences in either assay or at any ratio. A follow-up experiment (Experiment 2) employed identical dose ratios, but a higher dose of THC (7.5 mg/kg) and corresponding CBD doses (0.75, 7.5 mg/kg). Similar to the initial assessment, CBD had no effect on THC-induced place or taste conditioning at either dose ratio. These results may reflect the specific phytocannabinoid dose ratios examined or species differences in cannabinoid action. The current findings further suggest that altering CBD content in medicinal cannabis will likely have minimal effects in terms of tolerability. (PsycINFO Database Record

Considering the context: social factors in responses to drugs in humans.

BACKGROUND: Drugs are typically used in social settings. Here, we consider two factors that may contribute to this observation: (i) the presence of other people may enhance the positive mood effects of a drug, and conversely, (ii) drugs may enhance the value of social stimuli. METHODS: We review evidence from controlled laboratory studies with human volunteers, which investigated either of these interactions between social factors and responses to drugs. We examine the bidirectional effects of social stimuli and single doses of alcohol, stimulants, opioids, and cannabis. RESULTS: All four classes of drugs interact with social contexts, but the nature of these interactions varies across drugs, and depends on whether the context is positive or negative. CONCLUSIONS: Alcohol and stimulant drugs enhance the attractiveness of social stimuli and the desire to socialize, and social contexts, in turn, enhance these drugs' effects. In contrast, opioids and cannabis have subtler effects on social interactions and their effects are less influenced by the presence of others. Overall, there is stronger evidence that drugs enhance positive social contexts than that they dampen the negativity of unpleasant social settings. Controlled research is needed to understand the interactions between drugs of abuse and social contexts, to model and understand the determinants of drug use outside the laboratory.

Postpartum Changes in Mood and Smoking-Related Symptomatology: An Ecological Momentary Assessment Investigation.

Introduction: Postpartum smoking relapse is a highly prevalent public health problem. Mood and breast feeding are significantly associated with smoking relapse, although less is known about the temporality of these relationships. Therefore, this study utilized ecological momentary assessments (EMA) to prospectively examine changes in mood and smoking-related symptomatology in relationship to three events-childbirth, termination of breast feeding, and smoking relapse. We expected all three events to significantly alter mood and smoking-related symptomatology. Methods: We enrolled a sample of pregnant women who had recently quit smoking and intended to remain quit during the postpartum. Participants were randomized to active/placebo progesterone to prevent postpartum relapse. Participants also completed daily EMA to collect data mood and smoking-related symptomatology as well as our three events of interest. Results: Participants (n = 46) were, on average, 26.5 ± 0.8 years old and, prior to pregnancy, smoked 10.1 ± 0.7 cigarettes/day. We noted a number of significant within- and between-subject relationships. For example, participants reported a 24% decline in negative affect after childbirth (p = .0016). Among those who relapsed to smoking (n = 23), participants randomized to placebo had a significant increase in cigarette craving after relapse (ß = 1.06, 95% confidence interval [CI] = 0.62 to 1.49, p value = .0003), whereas participants randomized to active progesterone did not (ß = 0.63, 95% CI = -0.35 to 1.62, p value = .1824). Conclusions: These observations suggest that mood and smoking-related symptomatology are influenced by childbirth, breast feeding, smoking relapse, and use of exogenous progesterone. Future research should explore how these observations may inform novel postpartum smoking relapse-prevention interventions. Implications: Postpartum smoking relapse has been a persistent public health problem for more than 40 years. Although a number of significant predictors of postpartum smoking relapse have been identified (eg, depression and breast feeding), much of these analyses have relied on cross-sectional and/or self-reported retrospective data. Therefore, for the first time, we utilized ecological momentary assessment to explore the effect of childbirth, termination of breast feeding, and smoking relapse on mood and smoking-related symptomatology (eg, craving). Numerous significant relationships were observed, including a 96% increase in craving after smoking relapse. These novel observations can inform new and effective postpartum smoking relapse-prevention programs.

The effects of using the PReDicT Test to guide the antidepressant treatment of depressed patients: study protocol for a randomised controlled trial.

BACKGROUND: Antidepressant medication is commonly used to treat depression. However, many patients do not respond to the first medication prescribed and improvements in symptoms are generally only detectable by clinicians 4-6 weeks after the medication has been initiated. As a result, there is often a long delay between the decision to initiate an antidepressant medication and the identification of an effective treatment regimen. Previous work has demonstrated that antidepressant medications alter subtle measures of affective cognition in depressed patients, such as the appraisal of facial expression. Furthermore, these cognitive effects of antidepressants are apparent early in the course of treatment and can also predict later clinical response. This trial will assess whether an electronic test of affective cognition and symptoms (the Predicting Response to Depression Treatment Test; PReDicT Test) can be used to guide antidepressant treatment in depressed patients and, therefore, hasten treatment response compared to a control group of patients treated as usual. METHODS/DESIGN: The study is a randomised, two-arm, multi-centre, open-label, clinical investigation of a medical device, the PReDicT Test. It will be conducted in five European countries (UK, France, Spain, Germany and the Netherlands) in depressed patients who are commencing antidepressant medication. Patients will be randomised to treatment guided by the PReDicT Test (PReDicT arm) or to Treatment as Usual (TaU arm). Patients in the TaU arm will be treated as per current standard guidelines in their particular country. Patients in the PReDicT arm will complete the PReDicT Test after 1 (and if necessary, 2) weeks of treatment. If the test indicates non-response to the treatment, physicians will be advised to immediately alter the patient's antidepressant therapy by dose escalation or switching to another compound. The primary outcome of the study is the proportion of patients showing a clinical response (defined as 50% or greater decrease in baseline scores of depression measured using the Quick Inventory of Depressive Symptoms - Self-Rated questionnaire) at week 8. Health economic and acceptability data will also be collected and analysed. DISCUSSION: This trial will test the clinical efficacy, cost-effectiveness and acceptability of using the novel PReDicT Test to guide antidepressant treatment selection in depressed patients. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02790970 . Registered on 30 March 2016.

A pilot study of loss aversion for drug and non-drug commodities in cocaine users.

BACKGROUND: Numerous studies in behavioral economics have demonstrated that individuals are more sensitive to the prospect of a loss than a gain (i.e., loss aversion). Although loss aversion has been well described in "healthy" populations, little research exists in individuals with substance use disorders. This gap is notable considering the prominent role that choice and decision-making play in drug use. The purpose of this pilot study was to evaluate loss aversion in active cocaine users. METHODS: Current cocaine users (N=38; 42% female) participated in this within-subjects laboratory pilot study. Subjects completed a battery of tasks designed to assess loss aversion for drug and non-drug commodities under varying risk conditions. Standardized loss aversion coefficients (λ) were compared to theoretically and empirically relevant normative values (i.e., λ=2). RESULTS: Compared to normative loss aversion coefficient values, a precise and consistent decrease in loss aversion was observed in cocaine users (sample λ≈1). These values were observed across drug and non-drug commodities as well as under certain and risky conditions. CONCLUSIONS: These data represent the first systematic study of loss aversion in cocaine-using populations and provide evidence for equal sensitivity to losses and gains or loss equivalence. Futures studies should evaluate the specificity of these effects to a history of cocaine use as well as the impact of manipulations of loss aversion on drug use to determine how this phenomenon may contribute to intervention development efforts.

Psychological and neuropsychological assessment of regular hoasca users.

BACKGROUND: Hoasca (also called ayahuasca) is a N,N-dimethyltryptamine (DMT) - containing psychedelic brew originally used for magico-religious purposes by Amerindian populations of the Amazon Basin. Recently, Brazilian syncretic churches have helped spread the ritual use of hoasca to Western societies. The aim of this study was to evaluate substance use, and neuropsychological and psychological functioning of regular hoasca users within a religious setting. METHODS: Assessment of socio-economic status, mood, personality traits, impulsiveness, drug use, quality of life, extrinsic and intrinsic religiosity, and neuropsychological function was performed on 30 volunteers from a U.S. branch of União do Vegetal (UDV), a Brazilian religion which uses hoasca ritually. We also assessed 27 non-hoasca-using control subjects matched by socio-demographic profile and church attendance. Mann-Whitney U, chi-squared and Fisher tests were used to analyze differences between groups. Spearman's association and simple logistic regression tests were used to analyze the impact of frequency of hoasca use on dependent variables. RESULTS: Relative to the control group, the UDV group demonstrated lower scores for depression (p=0.043, r=.27) and confusion (p=0.032, r=.29) as assessed by the Profile of Mood States (POMS); higher scores on the instrument Big Five Inventory (BFI) for the personality traits agreeableness (p=0.028, r=.29) and openness (p=0.037, r=.28); higher scores on the quality life domain role limitations due to physical health as determined by the instrument Medical Outcomes Study Short Form-36 - SF-36 (p=0.035, r=.28); less recent use of alcohol (p<0.001, φc=.57), greater past use of alcohol to intoxication (p=0.007, φc=.36) and past use of cannabis (p=0.001, φc=.45) as measured by the Addiction Severity Index (ASI), 5th edition; better score on a measure of memory vulnerability to proactive interference as measured by the California Verbal Learning Test - CVLT (p=0.040, r=.27). Lifetime use of hoasca was positively correlated with role limitations due to physical health (p=0.032, rs=.39) and negatively associated with lifetime heavy alcohol use (p=0.034, OR=0.979). CONCLUSIONS: The findings indicate that religious use of hoasca does not adversely affect neuropsychological functioning and may have positive effects on substance abuse and mood.

Legal high industry business and lobbying strategies under a legal market for new psychoactive substances (NPS, 'legal highs') in New Zealand.

BACKGROUND: The establishment of a regulated legal market for new psychoactive substances (NPS, 'legal highs') under New Zealand's Psychoactive Substances Act (PSA) 2013 created a new commercial sector for psychoactive products, previously limited to alcohol and tobacco. AIM: To explore how the newly-recognised 'legal high' industry (LHI) viewed and responded to the changing regulatory and market environment. METHODS: In-depth interviews with six key informants (KI) from the LHI: a leading entrepreneur, chemist, industry spokesperson, retailer, product buyer and a researcher commissioned by the LHI - were conducted, transcribed and analysed thematically. Formative work for the study included review of official LHI documents (websites, public submissions, self-regulation documents). RESULTS: The LHI stakeholders espoused an idealistic mission of shifting recreational users of alcohol, tobacco and illegal drugs towards "safer alternatives". Passage of the PSA was viewed as a success after years of lobbying led by pioneering LHI actors. The growth and professionalisation of the LHI resulted in an increasingly commercial market which challenged idealistic views of the original operators. LHI KI reported the targeting of young and low income customers, price cutting and increasing the strength of products as business strategies. Attempts by the LHI to self-regulate did not prevent escalation in the strength of products and fall in retail prices. The LHI reported outsourcing of manufacturing and exporting of their products to other countries, demonstrating an international business model. CONCLUSION: There was a tension between profit and idealistic motivations within the LHI and this increased as the sector became more commercialised. While the LHI distanced itself from both alcohol and tobacco, they reported the use of similar marketing, business and political lobbying strategies. Rules for engagement with new 'addictive consumption industries' are required to clarify the role they are permitted to play in the development of regulatory regimes for new psychoactive substances.

Ecological momentary assessment of affect and craving in patients in treatment for prescription opioid dependence.

Low positive affect (PA) is likely to contribute to risk of relapse; however, it has received relatively little attention in clinical research. This study examined the associations among positive affect, negative affect (NA), and craving in medically withdrawn patients using ecological momentary assessment (EMA). Participants (n=73) provided reports of their PA, NA, and craving 4 times a day for an average of 10.47 (SD=3.80) days. Person- and day-level associations between PA, NA, and craving were examined using multilevel models. A significant interaction emerged between person- and day-level PA such that PA on the day level was negatively associated with craving for individuals experiencing low mean PA throughout the study. No significant interaction emerged between person- and day-level NA. The main effects for both person- and day-level NA were significant. Individuals experiencing high NA throughout the study experienced higher craving overall and on days when NA was higher than usual, craving was also higher. Results suggest that high person- and day-level NA may directly contribute to the risk for relapse via increased craving, whereas low day- level PA may contribute to risk for relapse among individuals exhibiting low person-level PA via increased craving on days with lower than average levels of PA for those individuals. Given that there is a paucity of research relating low PA to craving, continued investigation into how and when low PA creates risk for relapse is warranted.

Effects of G.H.3. On mental symptoms and health-related quality of life among older adults: results of a three-month follow-Up study in Shanghai, China.

OBJECTIVE: To explore the effects of daily use of Gerovital H3 (G.H.3.) tablets on relieving mental symptoms and improving health-related quality of life among Chinese older adults population. METHODS: In a randomized, placebo-controlled, double-blinded study, totally 100 eligible participants were randomly allocated into the G.H.3. group or the placebo group, administered either G.H.3. or placebo tablets and were followed up for three months. All of the participants were required to report their subjective feelings about quality of life, low mood, and anxiety by filling out Self-Rating Depression Scale (SDS), Self-Rating Anxiety Scale (SAS) and a 36-item Short-Form Health Survey (SF-36 scale). Physicians were responsible for evaluating the related mental health indications through physical examinations at the baseline and at the end of the intervention period. RESULTS: Participants were men and women between 50 and 89 years of age, with a median of 62.53 years. Before the intervention, the demographic characteristics and the baseline SF-36 scores, low mood, and anxiety statuses were comparable (p > 0.05). After the 12-week intervention, the scores of role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), mental health (MH) and health transition (HT), mental composite score (MCS) of the G.H.3. group were higher than the placebo group (p < 0.05), There were no significant differences in other domains in SF-36 and PCS between the two groups(p > 0.05), the scores of SDS and SAS in the G.H.3. group were both lower than the placebo group(p < 0.01), the prevalence rates of low moods in the G.H.3. group and the placebo group were 20.8 % and 34.0 % respectively, no significant difference was found (χ (2) =2.127,p = 0.145), while the prevalence rate of clinical anxiety concerns in the G.H.3. group was 2.1 %, which was significantly lower than the placebo group, 22.0 % (χ (2) =9.040,p < 0.001). CONCLUSIONS: Preliminarily use of G.H.3. shows positive effects in supporting mental health and improving general health and well-being while promoting the recovery of cognitive function among older adults. Most of SF-36 domains including PF, RP, BP, GH, VT, RE, MH, and HT, as well as the overall quality of life in MCS might benefit from taking G.H.3. tablets. Average levels of low moods and anxiety concerns were both reduced and the prevalence rate of clinical anxiety concerns were reduced.

The Vitamin D Assessment (ViDA) Study: design of a randomized controlled trial of vitamin D supplementation for the prevention of cardiovascular disease, acute respiratory infection, falls and non-vertebral fractures.

Observational studies have shown that low vitamin D status is associated with an increased risk of cardiovascular disease, acute respiratory infection, falls and non-vertebral fractures. We recruited 5110 Auckland adults, aged 50-84 years, into a randomized, double-blind, placebo-controlled trial to test whether vitamin D supplementation protects against these four major outcomes. The intervention is a monthly cholecalciferol dose of 100,000IU (2.5mg) for an estimated median 3.3 years (range 2.5-4.2) during 2011-2015. Participants were recruited primarily from family practices, plus community groups with a high proportion of Maori, Pacific, or South Asian individuals. The baseline evaluation included medical history, lifestyle, physical measurements (e.g. blood pressure, arterial waveform, lung function, muscle function), and a blood sample (stored at -80°C for later testing). Capsules are being mailed to home addresses with a questionnaire to collect data on non-hospitalized outcomes and to monitor adherence and potential adverse effects. Other data sources include New Zealand Ministry of Health data on mortality, hospitalization, cancer registrations and dispensed pharmaceuticals. A random sample of 438 participants returned for annual collection of blood samples to monitor adherence and safety (hypercalcemia), including repeat physical measurements at 12 months follow-up. The trial will allow testing of a priori hypotheses on several other endpoints including: weight, blood pressure, arterial waveform parameters, heart rate variability, lung function, muscle strength, gait and balance, mood, psoriasis, bone density, and chronic pain.