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Background The primary goals in conducting clinical trials of treatments for alcohol use disorders ( AUDs) are to identify efficacious treatments and determine which treatments are most efficacious for which patients. Accurate reporting of study design features and results is imperative to enable readers of research reports to evaluate to what extent a study has achieved these goals. Guidance on quality of clinical trial reporting has evolved substantially over the past 2 decades, primarily through the publication and widespread adoption of the Consolidated Standards of Reporting Trials statement. However, there is room to improve the adoption of those standards in reporting the design and findings of treatment trials for AUD. Methods This paper provides a narrative review of guidance on reporting quality in AUD treatment trials. Results Despite improvements in the reporting of results of treatment trials for AUD over the past 2 decades, many published reports provide insufficient information on design or methods. Conclusions The reporting of alcohol treatment trial design, analysis, and results requires improvement in 4 primary areas: (i) trial registration, (ii) procedures for recruitment and retention, (iii) procedures for randomization and intervention design considerations, and (iv) statistical methods used to assess treatment efficacy. Improvements in these areas and the adoption of reporting standards by authors, reviewers, and editors are critical to an accurate assessment of the reliability and validity of treatment effects. Continued developments in this area are needed to move AUD treatment research forward via systematic reviews and meta-analyses that maximize the utility of completed studies. [ABSTRACT FROM AUTHOR]

Background Over the past 60 years, the view that 'alcoholism' is a disease for which the only acceptable goal of treatment is abstinence has given way to the recognition that alcohol use disorders ( AUDs) occur on a continuum of severity, for which a variety of treatment options are appropriate. However, because the available treatments for AUDs are not effective for everyone, more research is needed to develop novel and more efficacious treatments to address the range of AUD severity in diverse populations. Here we offer recommendations for the design and analysis of alcohol treatment trials, with a specific focus on the careful conduct of randomized clinical trials of medications and nonpharmacological interventions for AUDs. Methods This paper provides a narrative review of the quality of published clinical trials and recommendations for the optimal design and analysis of treatment trials for AUDs. Results Despite considerable improvements in the design of alcohol clinical trials over the past 2 decades, many studies of AUD treatments have used faulty design features and statistical methods that are known to produce biased estimates of treatment efficacy. Conclusions The published statistical and methodological literatures provide clear guidance on methods to improve clinical trial design and analysis. Consistent use of state-of-the-art design features and analytic approaches will enhance the internal and external validity of treatment trials for AUDs across the spectrum of severity. The ultimate result of this attention to methodological rigor is that better treatment options will be identified for patients with an AUD. [ABSTRACT FROM AUTHOR]

Background Prenatal alcohol exposure can kill developing neurons, leading to microencephaly and mental retardation. However, not all fetuses are equally vulnerable to alcohol's neurotoxic effects. While some fetuses are severely affected and are ultimately diagnosed with fetal alcohol syndrome (FAS), others have no evidence of neuropathology and are behaviorally normal. These widely different outcomes among alcohol-exposed fetuses are likely due, in part, to genetic differences. Some fetuses possess genotypes that make them much more vulnerable than others to alcohol's teratogenic effects. However, to date, only 1 gene has been identified whose mutation can worsen alcohol-induced behavioral deficits in an animal model of FAS. That gene is neuronal nitric oxide synthase ( nNOS). The purpose of this study was to determine whether mutation of nNOS can likewise worsen alcohol-induced microencephaly and lead to permanent neuronal deficits. Methods Wild-type and nNOS−/− mice received alcohol (0.0, 2.2, or 4.4 mg/g) daily over postnatal days (PDs) 4 to 9. Beginning on PD 85, the mice underwent a series of behavioral tests; the results of which are reported in the companion paper. The brains were then weighed, and stereological cell counts were performed on the cerebral cortex and hippocampal formation, which are the brain regions that mediate the aforementioned behavioral tasks. Results Alcohol caused dose-dependent microencephaly, but only in the nNOS−/− mice and not in wild-type mice. Alcohol-induced neuronal losses were more severe in the nNOS−/− mice than in the wild-type mice in all of the brain regions examined, including the cerebral cortex, hippocampal CA3 subregion, hippocampal CA1 subregion, and dentate gyrus. Conclusions Targeted mutation of the nNOS gene increases the vulnerability of the developing brain to alcohol-induced growth restriction and neuronal losses. This increased neuropathology is associated with worsened behavioral dysfunction. The results demonstrate the critical importance of genotype in determining the outcome of developmental alcohol exposure. [ABSTRACT FROM AUTHOR]

Background This paper examines the prevalence, the symptom profile, and the drinking and sociodemographic predictors of current (past 12 months) DSM- IV alcohol abuse and dependence among Mexican Americans living along the U. S.- Mexico border and those living in metropolitan areas away from the border. Methods Respondents in the non-border areas (primarily Houston and Los Angeles) constitute a multistage probability sample ( N = 1,288) of these areas, interviewed as part of the 2006 Hispanic Americans Baseline Alcohol Survey ( HABLAS). Respondents in the border area ( N = 1,307) constitute a household probability sample of Mexican Americans living on the border. In both surveys, data were collected during computer-assisted interviews conducted in respondents' homes. The HABLAS and the border sample response rates were 76 and 67%, respectively. Results Although bivariate analyses revealed no overall differences between border and non-border locations, (negative) age trends were more pronounced on the border for male abuse and for dependence among both genders. Among females aged 18 to 29, border residence was linked to significantly higher rates of dependence. In multivariable analyses, the prevalence of male abuse declined more rapidly with age on the border than off the border. Other unique predictors of male abuse were Jewish/other religion and weekly volume of alcohol consumption. Being married or out of the workforce, attaining a higher education, having no religious preference, and weekly volume uniquely predicted female dependence. Age and weekly volume uniquely predicted male dependence. Conclusions The prevalence of alcohol use disorders among Mexican Americans on and off the U. S.- Mexico border largely mirrors previously documented patterns of alcohol consumption in these areas. For young Mexican American women in particular, border residence is linked to heightened vulnerability to alcohol dependence. [ABSTRACT FROM AUTHOR]

Background: The objective of this paper is to examine 10-year trends (1992 to 2002) in the number and type of indicators of DSM-IV abuse and dependence among whites, blacks, and Hispanics in the United States. Methods: Data are from the 1991 to 1992 National Longitudinal Alcohol Epidemiologic Survey (NLAES; n = 42,862) and the 2001 to 2002 National Epidemiologic Study on Alcohol and Related Conditions (NESARC; n = 43,093). Both surveys used multistage cluster sample procedures to select respondents 18 years of age and older from the U.S. household population. Results: Increases in the prevalence of alcohol abuse between 1992 and 2002 seem associated with a rise in the prevalence of the indicator for 'hazardous use.' which usually means reports of driving after drinking. The decrease in dependence was not associated with changes in a particular indicator. In addition, both in 1992 and 2002, 12.3 to 15.4% of the men and 5.2 to 7.9% of the women were diagnostic 'orphans.' These respondents reported 1 or 2 indicators of alcohol dependence as present. Conclusions: The observed trends in number and types of indicators of DSM-IV alcohol abuse and dependence were probably triggered by a complex interplay between individuals' volume and pattern of drinking and reactions from the drinkers' social environment. The close association between hazardous use of alcohol and the prevalence of abuse deserves further discussion. A medical diagnostic category should not be so dependent on a criterion that may be influenced by social situations. It is necessary to understand more about diagnostic 'orphans' to better design interventions to address their problems. [ABSTRACT FROM AUTHOR]

The 'prevention paradox,' a notion that most alcohol-related problems are generated by nonheavy drinkers, has significant relevance to public health policy and prevention efforts. The extent of the paradox has driven debate over the type of balance that should be struck between alcohol policies targeting a select group of high-risk drinkers versus more global approaches that target the population at-large. This paper examines the notion that most alcohol problems among 4 Hispanic national groups in the United States are attributable to moderate drinkers. A general population survey employing a multistage cluster sample design, with face-to-face interviews in respondents' homes was conducted in 5 metropolitan areas of the United States. Study participants included a total of 2,773 current drinkers 18 years and older. Alcohol consumed in the past year (bottom 90% vs. top 10%), binge drinking (binge vs. no binge), and a 4-way grouping defined by volume and binge criteria were used. Alcohol-related harms included 14 social and dependence problems. Drinkers at the bottom 90% of the distribution are responsible for 56 to 73% of all social problems, and for 55 to 73% of all dependence-related problems reported, depending on Hispanic national group. Binge drinkers are responsible for the majority of the social problems (53 to 75%) and dependence-related problems (59 to 73%), also depending on Hispanic national group. Binge drinkers at the bottom 90% of the distribution are responsible for a larger proportion of all social and dependence-related problems reported than those at the top 10% of the volume distribution. Cuban Americans are an exception. The prevention paradox holds when using volume-based risk groupings and disappears when using a binge-drinking risk grouping. Binge drinkers who drink moderately on an average account for more harms than those who drink heavily across all groups, with exception of Cuban Americans. [ABSTRACT FROM AUTHOR]

Background: There have been limited trend studies examining variations on the patterns of alcohol consumption among Whites, Blacks, and Hispanics in the United States. The current paper reports national trends in drinking patterns, volume of drinking (number of drinks per month), binge drinking, and drinking to intoxication among Blacks, Whites, and Hispanics over a period of 10 years and identifies sociodemographic predictors of these behaviors across the 3 ethnic groups. Methods: Data are from the 1991 to 1992 National Longitudinal Alcohol Epidemiologic Survey (NLAES; n = 42,862) and the 2001 to 2002 National Epidemiologic Study on Alcohol and Related Conditions (NESARC; n = 43,093). Both surveys used multistage cluster sample procedures to select respondents 18 years of age and older from the U.S. household population. Results: Trends varied across different dimensions of drinking and ethnic groups. There were no statistically significant differences in the mean number of drinks consumed per month among men and women in any of the 3 ethnic groups between 1992 and 2002, but there was a significant rise in the proportion of current drinkers in both genders and in all 3 ethnic groups. Multivariate analysis indicated that, compared to Whites in 1992, Blacks and Hispanics did not increase their volume of drinking, but Whites did. Drinking 5 or more drinks in day at all did not increase between 1992 and 2002, but drinking 5 or more drinks at least once a month was more likely for all groups in 2002 compared to Whites in 1992. Drinking to intoxication at all was more likely among Whites in 2002 than 1992, but drinking to intoxication at least once a month was more likely among Whites and Blacks in 2002 than 1992. Conclusion: The only common trend between 1992 and 2002 across both genders and 3 ethnic groups was a rise in the proportion of drinkers. There was also a rise in drinking 5 or more drinks in a day (Whites, Blacks, and Hispanics) and drinking to intoxication (Whites and Blacks), but this was limited to those reporting such drinking at least once a month. The reasons for these changes are many and may involve complex sociodemographic changes in the population. It is important for the field to closely monitor these cross-ethnic trends in alcohol consumption. [ABSTRACT FROM AUTHOR]