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Background: Transdermal alcohol biosensors can objectively monitor alcohol use by measuring transdermal alcohol concentration (TAC). However, it is unclear how sociodemographic and clinical factors that influence alcohol metabolism are associated with TAC. The main aim of this study was to examine how sociodemographic factors (sex, age, race/ethnicity) and clinical factors (body mass index, liver enzymes: alanine aminotransferase [ALT] and aspartate transaminase [AST]), alcohol use disorder, and HIV status were associated with TAC while controlling for level of alcohol use. Methods: We analyzed data from a prospective study involving contingency management for alcohol cessation among persons living with and without human immunodeficiency virus (HIV) that used the Secure Continuous Remote Alcohol Monitoring (SCRAM) biosensor. Forty‐three participants (Mage = 56.6 years; 63% male; 58% people living with HIV) yielded 183 SCRAM‐detected drinking days. Two indices derived from SCRAM: peak TAC (reflecting level of intoxication) and TAC area under the curve (TAC‐AUC; reflecting alcohol volume)—were the main outcomes. Self‐reported alcohol use (drinks/drinking day) measured by Timeline Followback was the main predictor. To examine whether factors of interest were associated with TAC, we used individual generalized estimating equations (GEE), followed by a multivariate GEE model to include all significant predictors to examine their associations with TAC beyond the effect of self‐reported alcohol use. Results: Number of drinks per drinking day (B = 0.29, p < 0.01) and elevated AST (B = 0.50, p = 0.01) were significant predictors of peak TAC. Positive HIV status, female sex, elevated AST, and number of drinks per drinking day were positively associated with TAC‐AUC at the bivariate level, whereas only self‐reported alcohol use (B = 0.85, p < 0.0001) and female sex (B = 0.67, p < 0.05) were significant predictors of TAC‐AUC at the multivariate level. Conclusions: HIV status was not independently associated with TAC. Future studies should consider the sex and liver function of the participant when using alcohol biosensors to measure alcohol use. [ABSTRACT FROM AUTHOR]

Background: Objective measurement of alcohol consumption is important for clinical care and research. Adjusting for self‐reported alcohol use, we conducted an individual participant data (IPD) meta‐analysis to examine factors associated with the sensitivity of phosphatidylethanol (PEth), an alcohol metabolite, among persons self‐reporting unhealthy alcohol consumption. Methods: We identified 21 eligible studies and obtained 4073 observations from 3085 participants with Alcohol Use Disorders Identification Test—Consumption (AUDIT‐C) positive scores (≥3 for women and ≥4 for men) and PEth measurements. We conducted 1‐step IPD meta‐analysis using mixed effects models with random intercepts for study site. We examined the associations between demographic (sex, race/ethnicity, and age) and biologic (body mass index—BMI, hemoglobin, HIV status, liver fibrosis, and venous versus finger‐prick blood collection) variables with PEth sensitivity (PEth≥8 ng/ml), adjusting for the level of self‐reported alcohol use using the AUDIT‐C score. Results: One third (31%) of participants were women, 32% were African, 28% African American, 28% White, and 12% other race/ethnicity. PEth sensitivity (i.e., ≥8 ng/ml) was 81.8%. After adjusting for AUDIT‐C, we found no associations of sex, age, race/ethnicity, or method of blood collection with PEth sensitivity. In models that additionally included biologic variables, those with higher hemoglobin and indeterminate and advanced liver fibrosis had significantly higher odds of PEth sensitivity; those with higher BMI and those living with HIV had significantly lower odds of PEth sensitivity. African Americans and Africans had higher odds of PEth sensitivity than whites in models that included biologic variables. Conclusions: Among people reporting unhealthy alcohol use, several biological factors (hemoglobin, BMI, liver fibrosis, and HIV status) were associated with PEth sensitivity. Race/ethnicity was associated with PEth sensitivity in some models but age, sex, and method of blood collection were not. Clinicians should be aware of these factors, and researchers should consider adjusting analyses for these characteristics where possible. [ABSTRACT FROM AUTHOR]

Background: Direct biomarkers such as phosphatidylethanol (PEth) have the capability to detect heavy alcohol use, but it is unclear how strongly self‐reported reduction in alcohol use correlates with reduction in PEth. We sought to explore the strength of correlation between reductions in self‐reported alcohol use and change in PEth among a sample of women living with HIV (WLWH) who participated in a clinical trial to reduce heavy alcohol use. We also sought to determine whether this correlation was stronger in women with lower body mass index (BMI) and women without an alcohol use disorder (AUD). Methods: 81 WLWH (mean age = 48.7, 80% Black) engaging in a randomized trial of naltrexone versus placebo with a positive baseline PEth (≥8 ng/ml), and alcohol use data at baseline, 2, and 7 months were included in this analysis. Spearman correlation coefficients were compared to measure the correlation between baseline PEth and number of drinks per week by demographic, biological, and alcohol use factors. Mini‐International Neuropsychiatric Interview was used to screen for AUD. Further analyses were stratified by BMI and AUD. Spearman correlation coefficients were calculated for the change in PEth and the change in number of drinks per week over 7 months, including 3 time‐points: baseline, 2, and 7 months. Results: At baseline, the correlation between baseline PEth and the number of drinks per week was significantly stronger for those with a BMI ≤25 compared to those with a BMI > 25 (r = 0.66; r = 0.26, respectively). Similarly, the correlation between baseline PEth and number of drinks was stronger for those who did not screen positive for AUD compared with those who did (r = 0.66; r = 0.25, respectively). When stratifying by BMI, a low‐to‐moderate correlation (r = 0.32, p = 0.02) was present for persons with a BMI > 25; when stratifying by AUD, a moderate correlation (r = 0.50, p < 0.01) was present for persons without an AUD between 0 and 2 months only. Conclusions: In this sample of WLWH, BMI and AUD affected the strength of correlation between PEth and drinks per week. Future work examining changes in PEth over time in broader populations is needed, particularly to understand the sex differences in PEth levels. [ABSTRACT FROM AUTHOR]

Background: Alcohol consumption is associated with poor health outcomes in women living with HIV (WLWH), but whether medication can help to reduce drinking in non–treatment‐seeking women or whether reduction in drinking improves HIV outcomes is unclear. We conducted a randomized clinical trial (RCT) of daily oral naltrexone (50 mg) versus placebo in WLWH who met criteria for current unhealthy alcohol use. Methods: WLWH with current unhealthy alcohol use (>7 drinks/wk or >3 drinks/occasion) were randomly assigned to daily oral naltrexone 50 mg (n = 96) or placebo (n = 98) for 4 months. Drinking outcomes, including the proportion of women who reduced (

Background: The relationship between alcohol consumption and atherosclerosis has not been sufficiently examined among people living with HIV (PLWH). Methods: We analyzed data from PLWH in the Women's Interagency HIV Study (WIHS; n = 1,164) and the Multicenter AIDS Cohort Study (MACS; n = 387) with no history of cardiovascular disease (CVD). Repeated measures of intima‐media thickness of the right common carotid artery (CCA‐IMT) were assessed using B‐mode ultrasound from 2004 to 2013. Current alcohol consumption was collected at time of CCA‐IMT measurement and was categorized according to gender‐specific weekly limits. Group‐based trajectory models categorized participants into past 10‐year consumption patterns (1994 to 2004). Multivariate generalized estimating equations were conducted to assess the association of past and current alcohol use patterns on change in CCA‐IMT by cohort, controlling for age, race, cigarette and illicit drug use, probable depression, HIV RNA viral load, antiretroviral therapy exposure, and hepatitis C coinfection. Results: Among the WIHS, past heavy alcohol consumption was associated with increased CCA‐IMT level over time (β = 8.08, CI 0.35, 15.8, p = 0.04), compared to abstinence. Among the MACS, compared to abstinence, all past consumption patterns were associated with increased CCA‐IMT over time (past low: β = 15.3, 95% CI 6.46, 24.2, p < 0.001; past moderate: β = 14.3, CI 1.36, 27.2, p = 0.03; past heavy: β = 21.8, CI 4.63, 38.9, p = 0.01). Current heavy consumption was associated with decreased CCA‐IMT among the WIHS (β = −11.4, 95% CI −20.2, −2.63, p = 0.01) and MACS (β = −15.4, 95% CI −30.7, −0.13, p = 0.04). No statistically significant time by consumption pattern effects were found. Conclusions: In both cohorts, 10‐year heavy consumption was associated with statistically significant increases in carotid artery thickness, compared to abstinence. Long‐term patterns of drinking at any level above abstinence were particularly significant for increases in IMT among men, with heavy consumption presenting with the greatest increase. Our results suggest a potentially different window of risk among past and current heavy drinkers. Further studies are needed to determine whether alcohol consumption level is associated with intermediate measures of atherosclerosis. Alcohol screening and interventions to reduce heavy consumption may benefit PLWH who are at risk of CVD. The relationship between alcohol consumption and atherosclerosis has not been sufficiently examined among people living with HIV (PLWH). We analyzed data from PLWH with no history of cardiovascular disease (CVD) using repeated measures of intima‐media thickness and alcohol consumption. Our results suggest a potentially different window of risk among past and current heavy drinkers. Alcohol screening and interventions to reduce heavy consumption may benefit PLWH who are at risk for CVD. [ABSTRACT FROM AUTHOR]

Background Biomarkers can play a key role in supplementing self-report information in alcohol research. In this study, we examined phosphatidylethanol (PEth) in comparison with self-reported alcohol use over time in a randomized controlled trial. Methods Participants were women living with HIV enrolled in a randomized placebo-controlled trial of naltrexone for reducing hazardous drinking. Drinking behavior was measured using Timeline Followback (TLFB), and PEth as a biomarker using dried blood spots. Data collected at baseline, and months 2 and 7 were analyzed. In addition to calculated Spearman's correlations, mixed-effects modeling was used to evaluate the changes in self-reported drinking and PEth, respectively, adjusting for body mass index (BMI). Results A total of 194 participants (83% black, mean age 48) were included in the analysis. PEth levels were significantly correlated with self-reported drinking via TLFB, Spearman's r = 0.21 at baseline, r = 0.29 at 2 months, and r = 0.28 at 7 months, respectively. No demographic or health factors, except for BMI, was associated with whether self-report was consistent with PEth. Mixed-effects model indicated that self-reported drinking showed significantly greater reductions in the naltrexone treatment group than the placebo group at the 2- and 7-month visits, whereas PEth measure only showed this difference at the 7-month follow-up. Conclusions The magnitude of the correlation between PEth and self-reported alcohol consumption was small. Caution is needed when using either self-report or PEth as a sole outcome measure for alcohol behavior changes in clinical trials. [ABSTRACT FROM AUTHOR]

Several clinical trials have evaluated naltrexone as a treatment for alcohol use disorders (AUDs), but few have focused on women. The aim of this review was to systematically review and summarize the evidence regarding the impact of naltrexone compared to placebo for attenuating alcohol consumption in women with an AUD. A systematic review was conducted using PubMed, Cochrane, Web of Science, CINAHL, and Alcohol Studies Database to identify relevant peer-reviewed randomized controlled trials ( RCTs) published between January 1990 and August 2016. Seven published trials have evaluated the impact of naltrexone on drinking outcomes in women distinct from men; 903 alcohol-dependent or heavy drinking women were randomized to receive once daily oral or depot (injectable) naltrexone or placebo with/without behavioral intervention. Two studies examining the quantity of drinks per day observed trends toward reduction in drinking quantity among women who received naltrexone versus placebo. The 4 studies examining the frequency of drinking had mixed results, with 1 study showing a trend that favored naltrexone, 2 showing a trend that favored placebo, and 1 that showed no difference. Two of the 3 studies examining time to relapse observed trends that tended to favor naltrexone for time to any drinking and time to heavy drinking among women who received naltrexone versus placebo. While the growing body of evidence suggests a variety of approaches to treat AUD, the impact of naltrexone to combat AUD in women is understudied. Taken together, the results suggest that naltrexone may lead to modest reductions in quantity of drinking and time to relapse, but not on the frequency of drinking in women. Future research should incorporate sophisticated study designs that examine gender differences and treatment effectiveness among those diagnosed with an AUD and present data separately for men and women. [ABSTRACT FROM AUTHOR]