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INTRODUCTION: Brick-and-mortar vape shops specialize in the sale of e-cigarettes and remain a primary source for purchasing emerging e-cigarette products. New regulatory policies have been implemented at local-, state- and federal-level; the retail environment at vape shops and product preferences among vape shop customers shifted accordingly. METHODS: From 2019 to 2023, we collected anonymous interview data from vape shop customers (n=572) from 83 vape shops in Southern California. We aggregated the data by month and treated each month as the unit of analysis to document changes in recruitment efforts among the vape shops in relation to major policy implementations over 4 years. We also examined the systematic fluctuations and trends in customers' e-cigarette product preferences and nicotine content in these products. RESULTS: The monthly average shop-level consent rate was 52.9% (SD=8.7), with an overall decreasing trend over time. It was necessary for our data collection team to approach a greater number of vape shops to obtain consent with implementation of various state and federal tobacco regulations and following COVID-19. We observed an increase in the purchase of disposable products and nicotine concentrations in the products, while the average use frequency remained the same. CONCLUSIONS: Our findings demonstrated that user preferences, product characteristics and challenges in research involving vape shops are closely associated to changes in regulations. We documented a dramatic increase in nicotine concentration in products. Future policies restricting the amount of nicotine in tobacco products at the federal level are necessary to protect consumers from further nicotine addiction. This study provides documentation over time of the drastic increases in nicotine concentration among e-cigarette users as a result of the fluctuations in the product market. Regulating nicotine content in tobacco products could safeguard against further unsafe modifications in e-cigarettes and other types of tobacco products.
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BACKGROUND: Retail sales of derived psychoactive cannabis products (DPCPs) have increased in the U.S. since passing the 2018 Farm Bill and is unregulated in most states. This study investigated the types and commonly sold brands of DPCPs as well as promotional pricing on April 20th, a day associated with cannabis use. METHODS: On April 19-20, 2023, investigators conducted telephone surveys with 98 retail stores that sold DPCPs in Fort Worth, Texas (where the market was largely unregulated). RESULTS: Delta-8, Delta-9, and Delta-10 THC products were widely available, with 97%, 72%, and 82% of stores selling each type, respectively. Fifteen additional DPCPs were identified, and selling blends containing multiple types of THC was common. Frequently sold brands included Cake, Medusa/Modus, Torch, Urb, Kik, Tyson, 3Chi, Casper, Hidden Hills, Esco Bars, Happi, Hometown Hero, STNR, Bomb Bars, Baked, Hi On Nature, Looper, and Space God. Overall, 45% reported having 4/20 specials discounting prices on DPCPs, smoking devices/accessories, or everything in the store. Several stores also sponsored 4/20 promotional events including free THC gummies and "live delta demos where people can test cartridges and try smoking flower in the store." CONCLUSIONS: Findings highlight the growing complexity of the DPCP market, including numerous different intoxicating compounds and blends. Policymakers, researchers, and public health professionals should consider these complexities, as well as the commonly sold brands, when developing strategies to regulate DPCPs and protect consumer safety. Pricing policies may be an especially important form of harm reduction during events associated with heavy cannabis use, including 4/20.
Subject(s)
Cannabis , Hallucinogens , Humans , Texas , Marketing , Commerce , Analgesics , Cannabinoid Receptor AgonistsABSTRACT
Background: The 2018 Farm Bill led to new types of derived psychoactive cannabis products (DPCPs) being sold throughout the United States. This study describes the new types and brands of DPCPs sold online. Materials and Methods: In May 2023, data were recorded from three top-trafficked U.S.-based DPCP retail websites, including information about each product (N=804). Results: DPCP modalities included disposable vapes (43%), edibles (29%), vape carts (18%), pre-rolls (7%), flower (2%), dabs (1%), and vape pods (<1%). Among the 118 brands, the most common were Exhale, Delta Extrax, Cake, URB, Looper, and TRE House. There were 26 different intoxicating compounds overall, the most prevalent being: Delta-8 tetrahydrocannabinol (THC), THC-P, Delta-9 THC, HHC, THC-A, Delta-10 THC, THC-H, THC-B, THC-JD, THC-X, HHC-P, and Delta-11 THC. Overall, 54% of products were blends, containing two to eight different intoxicating compounds in a single product. Discussion: This is the first study to systematically assess DPCPs sold online. Most of the DPCP market is comprised of vapes and edibles, but these products contain a wide array of compounds and blends. Data from this diverse, rapidly evolving market are needed to examine its consumer impact and inform public health policies and programs.
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Aim: This largest-of-its-kind study evaluated the clinical utility of CA125 and OVA1, commonly used as ovarian tumor markers for assessing the risk of malignancy. The research focused on the ability and utility of these tests to reliably predict patients at low risk for ovarian cancer. Clinical utility endpoints were 12-month maintenance of benign mass status, reduction in gynecologic oncologist referral, avoidable surgical intervention and associated cost savings. Materials & methods: This was a multicenter retrospective review of data from electronic medical records and administrative claims databases. Patients receiving a CA125 or OVA1 test between October 2018 and September 2020 were identified and followed for 12 months using site-specific electronic medical records to assess tumor status and utilization outcomes. Propensity score adjustment was used to control for confounding variables. Payer allowed amounts from Merative MarketScan Research Databases were used to estimate 12-month episode-of-care costs per patient, including surgery and other interventions. Results: Among 290 low-risk OVA1 patients, 99.0% remained benign for 12 months compared with 97.2% of 181 low-risk CA125 patients. The OVA1 cohort exhibited 75% lower odds of surgical intervention in the overall sample of patients (Adjusted OR: 0.251, p ≤ 0.0001), and 63% lower odds of gynecologic oncologist utilization among premenopausal women (Adjusted OR: 0.37, p = 0.0390) versus CA125. OVA1 demonstrated significant savings in surgical interventions ($2486, p ≤ 0.0001) and total episode-of-care costs ($2621, p ≤ 0.0001) versus CA125. Conclusion: This study underscores the utility of a reliably predictive multivariate assay for assessing ovarian cancer risk. For patients assessed at low risk of ovarian tumor malignancy, OVA1 is associated with a significant reduction in avoidable surgeries and substantial cost savings per patient. OVA1 is also associated with a significant reduction in subspecialty referrals for low-risk premenopausal patients.
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Ovarian Neoplasms , Female , Humans , Ovarian Neoplasms/diagnosis , Ovarian Neoplasms/surgery , Risk , Retrospective Studies , Biomarkers, Tumor , AlgorithmsABSTRACT
Adverse childhood experiences (ACE) have a strong association with alcohol and drug use; however, more research is needed to identify protective factors for this association. The present study assesses the longitudinal impact of ACE on problematic alcohol and drug use and the potential moderating effect of perceived social support. Data (n = 1404) are from a sample of Hispanic youth surveyed in high school through young adulthood. Linear growth curve models assessed the effect of ACE and perceived social support over time on problematic alcohol and drug use. Results indicated youth with ACE (vs. those without ACE) report more problematic alcohol and drug use in adolescence and have increased rates into young adulthood. Additionally, findings suggest that social support in high school may moderate the effects of ACE on problematic use over time. Among youth with high levels of support, the association of ACE with problematic alcohol and drug use was diminished. Although ACE can have a persistent impact on problematic alcohol and drug use from adolescence into adulthood, high social support during adolescence may mitigate the negative effects of ACE, lowering early problematic alcohol and drug use, offering the potential for lasting benefits.
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Adverse Childhood Experiences , Substance-Related Disorders , Adolescent , Humans , Young Adult , Adult , Risk Factors , Longitudinal Studies , Social SupportABSTRACT
BACKGROUND: Tobacco regulations and COVID-19 state orders have substantially impacted vape retail. This study assessed vape retailers' perspectives regarding regulations and future retail activities. METHODS: In March-June 2021, 60 owners or managers of vape or vape-and-smoke shops (n = 34 vs. n = 26) in six US metropolitan areas completed an online survey assessing: (1) current and future promotional strategies and product offerings; and (2) experiences with federal minimum legal sales age (T21) policies, the federal flavored e-cigarette ban, and COVID-19-related orders. Quantitative data were analyzed descriptively; qualitative responses to open-ended questions were thematically analyzed. RESULTS: Most participants had websites (65.0%), used social media for promotion (71.7%), offered curbside pickup (51.7%), and sold CBD (e.g., 73.3% vape products, 80.0% other); many also sold other tobacco products. Knowledge varied regarding state/local policies in effect before federal policies. Participants perceived tobacco regulations and COVID-19 orders as somewhat easy to understand/implement and perceived noncompliance consequences as somewhat severe. Qualitative themes indicated concerns regarding regulations' negative impacts (e.g., sales/customer loss, customers switching to combustibles), insufficient evidence base, challenges explaining regulations to customers, and concerns about future regulatory actions. CONCLUSIONS: Surveillance of tobacco retail, consumer behavior, and regulatory compliance is warranted as policies regarding nicotine and cannabis continue evolving.
Subject(s)
COVID-19 , Electronic Nicotine Delivery Systems , Tobacco Products , Vaping , COVID-19/epidemiology , Commerce , Humans , Smoke , Nicotiana , Vaping/epidemiologyABSTRACT
BACKGROUND: Current treatment of vulvovaginal candidiasis (VVC) is largely limited to azole therapy. Ibrexafungerp is a first-in-class triterpenoid antifungal with broad-spectrum anti-Candida fungicidal activity. The objective of this study was to evaluate the efficacy and safety of ibrexafungerp compared with placebo in patients with acute VVC. METHODS: Patients were randomly assigned 2:1 to receive ibrexafungerp (300 mg twice for 1 day) or placebo. The primary endpoint was the percentage of patients with a clinical cure (complete resolution of vulvovaginal signs and symptoms [VSS] = 0) at test-of-cure (day 11 ± 3). Secondary endpoints included the percentage of patients with mycological eradication, overall success (clinical cure and mycological eradication), clinical improvement (VSS ≤ 1) at test-of-cure, and symptom resolution at follow-up (day 25 ± 4). RESULTS: Patients receiving ibrexafungerp had significantly higher rates of clinical cure (50.5% [95/188] vs 28.6% [28/98]; P = .001), mycological eradication (49.5% [93/188] vs 19.4% [19/98]; P < .001), and overall success (36.0% [64/178] vs 12.6% [12/95]; P < .001) compared with placebo. Symptom resolution was sustained and further increased with ibrexafungerp compared with placebo (59.6% [112/188] vs 44.9% [44/98]; P = .009) at follow-up. Post hoc analysis showed similar rates of clinical cure and clinical improvement at test-of-cure for Black patients (54.8% [40/73] and 63.4% [47/73], respectively) and patients with a body mass index >35 (54.5% [24/44] and 68.2% [30/44], respectively) compared with overall rates. Ibrexafungerp was well tolerated. Adverse events were primarily gastrointestinal and mild in severity. CONCLUSIONS: Ibrexafungerp provides a promising safe and efficacious oral treatment that mechanistically differs from current azole treatment options for acute VVC.
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Candidiasis, Vulvovaginal , Triterpenes , Antifungal Agents/adverse effects , Azoles/therapeutic use , Candidiasis, Vulvovaginal/drug therapy , Female , Glycosides/therapeutic use , Humans , Triterpenes/adverse effectsABSTRACT
OBJECTIVES: In February 2020, the US Food and Drug Administration issued a guidance restricting the sales and distribution of cartridge-based e-cigarettes with flavours other than tobacco and menthol. Disposable devices were exempt from this guidance. This study examined the prevalence of disposable pod use and flavour preference compared with refillable pod and other e-cigarette users among vape shop customers. DESIGN: Cross-sectional study. SETTING: In July 2019-March 2020, trained data collectors visited 44 vape shops in California with permission to recruit customers from shop owners. PARTICIPANTS: Intercept interviews with 276 customers were conducted. OUTCOMES AND PROCEDURES: Customers were grouped based on self-reported device type used most often (disposable pod, refillable pod and other e-cigarettes). Groups were compared on self-reported demographics, flavours preferred, daily e-cigarette use, preferred nicotine concentration levels and cigarette use. RESULTS: Of the 276 customers surveyed, 11.2% used disposable pods in the past 30 days. Among disposable pod users, fruit/candy (80.7%), mint (77.4%) and menthol (67.7%) were common preferred flavours, while tobacco flavours were less commonly preferred (19.4%). When compared with refillable pod and other non-pod e-cigarette device users, disposable pod users were younger, used higher nicotine concentration levels, were more likely to prefer mint and menthol flavours and use e-cigarettes as their first product, while less likely to ever use cigarettes and use e-cigarettes daily. DISCUSSION: Despite using higher nicotine levels and preferred menthol/mint flavours more often than users of other devices, disposable pod users reported lower prevalence of lifetime smoking and daily vaping and were younger. Given the current findings, regulations addressing non-tobacco flavours and nicotine concentration in disposable pod devices merit consideration in efforts to reduce vaping in younger adult never smokers.
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Electronic Nicotine Delivery Systems , Tobacco Products , Vaping , Adult , California/epidemiology , Consumer Behavior , Cross-Sectional Studies , Humans , PrevalenceABSTRACT
Objectives To evaluate disparities in youth e-cigarette use patterns and flavor use by race/ethnicity over time. Methods We used data from the US 2014-2019 National Youth Tobacco Survey (NYTS) to examine trends in dual use (co-use of e-cigarettes and cigarettes or other tobacco products), occasional (≤ 5 days) versus frequent use (≥ 20 days) in the past 30 days, and flavor use among current (past-30-day) e-cigarette users (n = 13 178) across racial/ethnic groups (non-Hispanic Whites, non-Hispanic Blacks, Hispanics/Latinos, and non-Hispanic others). Results Among current e-cigarette users, dual use and occasional use decreased significantly from 2014 to 2019 across racial and ethnic groups except for non-Hispanic Blacks; frequent use and flavored e-cigarette use increased among non-Hispanic Whites, Hispanics/Latinos, and non-Hispanic others but not among non-Hispanic Blacks. In 2019, non-Hispanic Black e-cigarette users were more likely to report dual use (adjusted odds ratio [AOR] = 2.2; 95% confidence interval [CI] = 1.5, 3.2; P < .001) and occasional use of e-cigarettes (AOR = 3.7; 95% CI = 2.3, 5.9; P < .001) but less likely to report frequent use (AOR = 0.2; 95% CI = 0.1, 0.4; P < .001) and flavored e-cigarette use (AOR = 0.4; 95% CI = 0.3, 0.5; P < .001) than their White peers. Conclusions Youth e-cigarette use patterns differed considerably across racial/ethnic groups, and tailored strategies to address disparities in e-cigarette use are needed. (Am J Public Health. 2021;111(11):2050-2058. https://doi.org/10.2105/AJPH.2021.306448).
Subject(s)
Electronic Nicotine Delivery Systems/statistics & numerical data , Ethnicity/statistics & numerical data , Adolescent , Cross-Sectional Studies , Female , Humans , Male , United StatesABSTRACT
BACKGROUND: College students are among the heaviest users of smartphones and the Internet, and there is growing concern regarding problematic Internet (PIU) and smartphone use (PSU). A subset of adverse childhood experiences, household dysfunction [(HHD) e.g.; parental substance use, mental illness, incarceration, suicide, intimate partner violence, separation/divorce, homelessness], are robust predictors of behavioral disorders; however, few studies have investigated the link between HHD and PIU and PSU and potential protective factors, such as social support, among students. METHODS: Data are from a diverse California student sample (N = 1027). The Smartphone Addiction Scale-Short Version and Internet Addiction Test assessed dimensions of addiction. Regression models tested associations between students' level of HHD (No HHD, 1-3 HHD, ≥4 HHD) and PSU and PIU, and the role of extrafamilial social support in these relationships, adjusting for age, gender, ethnicity, SES, employment loss due to COVID-19, and depression. RESULTS: Compared to students reporting no HHD, students with ≥4 HHD had twice the odds (AOR: 2.03, 95% CI: 1.21-3.40) of meeting criteria for PSU, while students with 1-3 HHD and ≥4 HHD had three and six times the odds of moderate to severe PIU (AORs: 2.03-2.46, CI:1.21-3.96) after adjusting for covariates. Extrafamilial social support was inversely associated with PIU and moderated the HHD-PSU association for students with 1-3 HHD. CONCLUSION: Students exposed to HHD may be especially vulnerable to developing behavioral addictions such as PSU and PIU. Extrafamilial social support offset the negative effects of HHD for PSU among the moderate risk group; implications for prevention efforts are discussed.
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Adverse Childhood Experiences , Behavior, Addictive , COVID-19 , Behavior, Addictive/epidemiology , Humans , Internet , SARS-CoV-2 , SmartphoneABSTRACT
BACKGROUND: There has been a tremendous increase in the use of smartphones among college students and alongside the benefits there is growing concern over problematic/addictive smartphone use (PSU). Among the most robust predictors of behavioral and substance use disorders are a subset of adverse childhood experiences conceptualized as household dysfunction (HHD). Despite the high prevalence of HHD and risk of PSU among college students, research investigating the link between HHD and PSU among college populations is sparse, especially in the United States. METHODS: Students (N = 351) from a diverse, southern California university responded to an online survey. Regression models assessed the association between HHD (e.g., parent alcohol and drug use, mental health, incarceration, suicide, intimate partner violence, separation/divorce, and homelessness; categorized into 0, 1-3, and 4 or more) and PSU using Smartphone Addiction Scale short version (SAS-SV) scale, adjusted for covariates. RESULTS: Over 50% of students reported at least one type of household dysfunction and about 25% were at high risk for PSU. Compared to students who report no household stressors, students with 1-3 had twice the odds (AOR: 2.11, 95% CI: 1.13-3.83) and students with 4 or more had four times the odds (AOR: 4.01, 95% CI: 2.35-6.82) of PSU, after adjusting for covariates. There were no sex differences in this association. CONCLUSION: Findings suggest that household dysfunction can increase the likelihood of developing behavioral disorders such as PSU. Implications for prevention efforts are discussed.
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Adverse Childhood Experiences , Behavior, Addictive , Behavior, Addictive/epidemiology , Humans , Pilot Projects , Smartphone , StudentsABSTRACT
This study examined intragroup xenophobic attitudes, ethnic identity, and substance use (N = 905). Drawing on cognitive dissonance theory, we hypothesized that intragroup xenophobic attitudes among Latinx individuals would be associated with higher levels of substance use (SU) in early adulthood and that ethnic identity would increase the strength of that association. We found that in 10th grade, xenophobic attitudes were higher among respondents with lower ethnic identity, a longer family history in the United States, and less stress. In a longitudinal analysis, SU in emerging adulthood was highest among males, those reporting higher stress in 10th grade, and those with a longer family history in the United States. There was a significant interaction of ethnic identity and xenophobia on substance use (ß = -.12, p < .001), indicating that substance use was higher among Latinxs with low ethnic identity who harbor xenophobic attitudes. Findings are explained using system justification theory because intragroup xenophobia appears to operate as a coping strategy that is maladaptive for Latinx individuals reporting low ethnic identity but somehow useful to those with high ethnic identity.
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Adolescent Behavior/ethnology , Emigrants and Immigrants/statistics & numerical data , Group Processes , Hispanic or Latino/statistics & numerical data , Social Identification , Stress, Psychological/ethnology , Substance-Related Disorders/ethnology , Xenophobia/ethnology , Adolescent , Female , Humans , Longitudinal Studies , Male , Time Factors , United States/ethnologyABSTRACT
OBJECTIVE: To evaluate the safety and efficacy of ospemifene for the treatment of moderate to severe vaginal dryness in postmenopausal women with vulvovaginal atrophy (VVA). METHODS: This 12-week, multicenter, double-blind phase 3 study randomized postmenopausal women (aged 40-80 years) with VVA and moderate to severe vaginal dryness as their most bothersome symptom to daily oral ospemifene 60âmg or placebo. Coprimary efficacy endpoints included changes from baseline to week 12 in percentages of vaginal parabasal and superficial cells, vaginal pH, and vaginal dryness severity with ospemifene versus placebo; other secondary endpoints were evaluated (weeks 4, 8, and 12). Safety was assessed by treatment-emergent adverse events (TEAEs) and endometrial biopsies. RESULTS: Women (nâ=â631; ospemifene [nâ=â316], placebo [nâ=â315]) had a mean age of 59.8 years, a mean body mass index of 27.2âkg/m, and most were white. Ospemifene significantly improved (Pâ<â0.0001) the percentages of parabasal and superficial cells, vaginal pH, and severity of vaginal dryness severity compared with placebo at week 12; significant between-group differences were noted by week 4. Secondary endpoints of dyspareunia (Pâ<â0.001), maturation value (Pâ<â0.0001), and the Female Sexual Function Index (Pâ<â0.05) also significantly improved with ospemifene versus placebo at week 12. Significantly more women responded (31.5% vs 6.0%; Pâ<â0.0001) or were satisfied (49.2% vs 33.8%; Pâ=â0.0007) with ospemifene versus placebo at week 12. No unexpected TEAEs, treatment-related serious TEAEs, thrombotic events, or endometrial hyperplasia or carcinoma were observed. CONCLUSIONS: Ospemifene was effective and well tolerated for the treatment of moderate-to-severe vaginal dryness in postmenopausal women with VVA.
Subject(s)
Postmenopause/physiology , Selective Estrogen Receptor Modulators/adverse effects , Selective Estrogen Receptor Modulators/therapeutic use , Severity of Illness Index , Tamoxifen/analogs & derivatives , Vagina/pathology , Vaginal Diseases/drug therapy , Vulva/pathology , Adult , Aged , Aged, 80 and over , Atrophy/drug therapy , Double-Blind Method , Dyspareunia/drug therapy , Female , Hot Flashes/etiology , Humans , Middle Aged , Patient Satisfaction , Selective Estrogen Receptor Modulators/administration & dosage , Tamoxifen/administration & dosage , Tamoxifen/adverse effects , Tamoxifen/therapeutic use , Treatment OutcomeABSTRACT
Background: Polytobacco product use is suspected to be common, dynamic across time, and increase risk for adverse behavioral outcomes. We statistically modeled characteristic types of polytobacco use trajectories during mid-adolescence and tested their prospective association with substance use and mental health problems. Methods: Adolescents (N = 3393) in Los Angeles, CA, were surveyed semiannually from 9th to 11th grade. Past 6-month combustible cigarette, e-cigarette, or hookah use (yes/no) over four assessments were analyzed using parallel growth mixture modeling to identify a parsimonious set of polytobacco use trajectories. A tobacco product use trajectory group was used to predict substance use and mental health at the fifth assessment. Results: Three profiles were identified: (1) tobacco nonusers (N = 2291, 67.5%) with the lowest use prevalence (<3%) of all products across all timepoints; (2) polyproduct users (N = 920, 27.1%) with moderate use prevalence of each product (8-35%) that escalated for combustible cigarettes but decreased for e-cigarettes and hookah across time; and (3) chronic polyproduct users (N = 182, 5.4%) with high prevalence of each product use (38-86%) that escalated for combustible cigarettes and e-cigarettes. Nonusers, polyproduct users, and chronic polyproduct users reported successively higher alcohol, marijuana, and illicit drug use and ADHD at the final follow-up, respectively. Both tobacco using groups (vs. nonusers) reported greater odds of depression and anxiety at the final follow-up but did not differ from each other. Conclusions: Adolescent polytobacco use may involve a common moderate risk trajectory and a less common high-risk chronic trajectory. Both trajectories predict substance use and mental health symptomology. Implications: Variation in use and co-use of combustible cigarette, e-cigarette, and hookah use in mid-adolescence can be parsimoniously characterized by a small set common trajectory profiles in which polyproduct use are predominant patterns of tobacco product use, which predict adverse behavioral outcomes. Prevention and policy addressing polytobacco use (relative to single product use) may be optimal tobacco control strategies for youth, which may in turn prevent other forms of substance use and mental health problems.
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Adolescent Behavior/psychology , Tobacco Products/statistics & numerical data , Tobacco Use Disorder/epidemiology , Tobacco Use/epidemiology , Adolescent , Female , Humans , Longitudinal Studies , Male , Mental Health , Risk Factors , Tobacco Products/classification , Tobacco Use/psychologyABSTRACT
Background: Recurrent vulvovaginal candidiasis (RVVC) is a problematic form of mucosal Candida infection, characterized by repeated episodes per year. Candida albicans is the most common cause of RVVC. Currently, there are no immunotherapeutic treatments for RVVC. Methods: This exploratory randomized, double-blind, placebo-controlled trial evaluated an immunotherapeutic vaccine (NDV-3A) containing a recombinant C. albicans adhesin/invasin protein for prevention of RVVC. Results: The study in 188 women with RVVC (n = 178 evaluable) showed that 1 intramuscular dose of NDV-3A was safe and generated rapid and robust B- and T-cell immune responses. Post hoc exploratory analyses revealed a statistically significant increase in the percentage of symptom-free patients at 12 months after vaccination (42% vaccinated vs 22% placebo; P = .03) and a doubling in median time to first symptomatic episode (210 days vaccinated vs 105 days placebo) for the subset of patients aged <40 years (n = 137). The analysis of evaluable patients, which combined patients aged <40 years (77%) and ≥40 years (23%), trended toward a positive impact of NDV-3A versus placebo (P = .099). Conclusions: In this unprecedented study of the effectiveness of a fungal vaccine in humans, NDV-3A administered to women with RVVC was safe and highly immunogenic and reduced the frequency of symptomatic episodes of vulvovaginal candidiasis for up to 12 months in women aged <40 years. These results support further development of NDV-3A vaccine and provide guidance for meaningful clinical endpoints for immunotherapeutic management of RVVC. Clinical Trials Registration: NCT01926028.
Subject(s)
Candidiasis, Vulvovaginal/therapy , Fungal Proteins/therapeutic use , Fungal Vaccines/therapeutic use , Immunotherapy , Adolescent , Adult , B-Lymphocytes/immunology , Candida albicans/drug effects , Candidiasis, Vulvovaginal/immunology , Double-Blind Method , Female , Fungal Vaccines/adverse effects , Humans , Immunogenicity, Vaccine , Injections, Intramuscular , Middle Aged , Recurrence , T-Lymphocytes/immunology , Young AdultABSTRACT
BACKGROUND AND AIMS: Anhedonia-a transdiagnostic psychopathological trait indicative of inability to experience pleasure-could lead to and result from adolescent marijuana use, yet this notion has not been tested. This study aimed to estimate the association of: (1) anhedonia at age 14 with rate of change in marijuana use over an 18-month follow-up, and (2) marijuana use at age 14 with rate of change in anhedonia over follow-up. Secondary aims were to test whether gender, baseline marijuana use history and peer marijuana use moderated these associations. DESIGN: Observational longitudinal cohort repeated-measures design, with baseline (age 14 years), 6-month, 12-month and 18-month follow-up assessments. SETTINGS: Ten public high schools in Los Angeles, CA, USA, 2013-15. PARTICIPANTS: Students [n = 3394; 53.5% female, mean (standard deviation) age at baseline = 14.1 (0.42)]. MEASUREMENTS: Self-report level of anhedonia on the Snaith-Hamilton Pleasure Scale and frequency of marijuana use in the past 30 days. FINDINGS: Parallel process latent growth curve models adjusting for confounders showed that baseline anhedonia level was associated positively with the rate of increase in marijuana use frequency across follow-ups [ß, 95% confidence interval (CI) = 0.115 (0.022, 0.252), P = 0.03]. Baseline marijuana use frequency was not related significantly to the rate of change in anhedonia across follow-ups [ß, 95% CI = -0.015 (-0.350, 0.321), P = 0.93]. The association of baseline anhedonia with faster marijuana use escalation was amplified among adolescents with (versus without) friends who used marijuana at baseline [ß, 95% CI = 0.179 (0.043, 0.334) versus 0.064 (-0.071, 0.187), interaction P = 0.04], but did not differ by gender or baseline ever marijuana use. CONCLUSIONS: In mid-adolescence, anhedonia is associated with subsequent marijuana use escalation, but marijuana use escalation does not appear to be associated with subsequent anhedonia.
Subject(s)
Adolescent Behavior/psychology , Anhedonia/drug effects , Marijuana Use/psychology , Adolescent , Cohort Studies , Female , Humans , Longitudinal Studies , Los Angeles , Male , Self ReportABSTRACT
In this review, I examine the definition, etiology, measurement, prevention and treatment of workaholism, based on a systematic search of the literature. While there is some debate regarding the parameters of the concept, viewed as a negative consequential addiction, workaholism involves excessive time spent working, preoccupation with work to the exclusion of other life domains, loss of control over the parameters of one's work and disenchantment with work, and negative social, emotional, and health consequences. The etiology of workaholism is not clear but may pertain to persons with compulsive personality traits, who are driven to work harder than that demanded from work contexts, and who have learned to place work as a main means of gratification compared to other lifestyle alternatives. Most measurement approaches rely on self-report questionnaires, tested primarily with convenience samples. Refinement of current assessments is ongoing. Prevention and treatment implications are discussed, which include intra- and extra-personal level approaches. Finally, limitations of the work completed in this arena are mentioned and needed future research directions are suggested.
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BACKGROUND: The physical environment influences adolescent health behavior and personal development. This article examines the relationship between level of school disrepair and substance use among students attending regular high school (RHS) and alternative high school (AHS). METHODS: Data were collected from students (N = 7058) participating in 2 randomized controlled trials of a school-based substance abuse prevention program implemented across the United States. Students provided substance use and demographic information on a self-reported survey. Data for the physical disrepair of schools were collected from individual rater observations of each school environment. We hypothesized that school disrepair would be positively associated with substance use controlling for individual characteristics and a socioeconomic status proxy. Multilevel mixed modeling was used to test the hypothesized association and accounted for students nested within schools. RESULTS: Findings indicated that students attending AHS with greater school disrepair were more likely to report the use of marijuana and other illicit drugs (ie, cocaine, heroin). Students attending RHS with greater school disrepair were less likely to report smoking cigarettes. CONCLUSIONS: Differences in findings between RHS and AHS students are discussed, and implications for substance use prevention programming are offered. Students attending AHS with greater school disrepair may require more substance abuse prevention programming, particularly to prevent illicit substance use.
Subject(s)
Environment , Schools , Substance-Related Disorders/epidemiology , California , Child , Female , Humans , Male , Poverty/statistics & numerical data , Racial Groups/statistics & numerical data , Smoking/epidemiology , Substance-Related Disorders/ethnologyABSTRACT
BACKGROUND: Adolescent peer group self-identification refers to adolescents' affiliation with reputation-based peer groups such as "Goths" or "Jocks." These groups tend to vary on normative characteristics, including the group members' attitudes and behaviors. This article examined whether adolescents' baseline peer group self-identification predicted their self-reported relational and physical aggression 1 year later. METHODS: Self-report data were collected from 1614 students from 9 regular and 9 continuation (alternative) high schools in Southern California, at baseline and 1-year follow-up. Subjects' mean baseline age was 15.21 years (SD = 1.18) and 51.6% of the subjects were female. RESULTS: Findings indicated that compared with self-identified "Regular" or "Normal" students, adolescents who identified with high-risk peer groups (eg, "Druggies,""Goths") tended to report higher relational and physical aggression 1 year later, controlling for baseline aggression and demographic variables. In addition, adolescents' self-identification with high-status peer groups (eg, "Jocks,""Populars") was predictive of higher relational aggression 1 year later. Gender and school type (ie, regular vs continuation) were not found to moderate these effects. CONCLUSIONS: It appears that peer group self-identification is a salient predictor of physical and relational aggression across gender and school type. Adolescents who identify with high-risk peer groups tend to report higher levels of physical as well as relational aggression in the future. In addition, adolescents who affiliate with elite groups tend to become more relationally aggressive over time. School-based prevention programs targeting aggression may benefit from addressing the impacts of peer group self-identification on adolescents' aggressive behavior.