Background: Risky alcohol consumption is on the rise among older adults. Biomarkers such as phosphatidylethanol (PEth) have been used to evaluate the correspondence between an objective, laboratory-based biomarker and self-report of alcohol consumption. This study examined the relationship between PEth, self-report of alcohol consumption, and health indices in a sample of community-dwelling older to middle-age adults (aged 35 to 89) with healthy and risky levels of alcohol consumption. Methods: Self-reports of alcohol consumption were collected using the Alcohol Use Disorders Identification Test (AUDIT) and Form 30. In addition, indices of health along with a blood sample to determine PEth values were collected (N = 183). Results: PEth was correlated with age, AUDIT-C, AUDIT total, alcohol consumption, mood, and liver function measures but not with medical comorbidity or body mass index (J Gerontol B Psychol Sci Soc Sci 73, 2018, 633). Alcohol consumption over the past 30 days measured with Form 30 was the strongest predictor of PEth levels for both middle-age and older adults, with age a small contributing predictor. General alcohol consumption patterns for amount of alcohol consumed over a 30-day period revealed middle-age adults consumed larger amounts of alcohol compared with older adults, but older adults consumed alcohol on more days than middle-age adults. Middle-age participants evidenced higher PEth levels than older adults at comparable drinking rates. Conclusions: Overall, findings suggest a strong relationship between alcohol consumption and PEth levels with age a small but contributing factor to predicting PEth levels.
Background The coronavirus disease 2019 (COVID-19) pandemic has challenged researchers performing clinical trials to develop innovative approaches to mitigate infectious risk while maintaining rigorous safety monitoring. Methods In this report we describe the implementation of a novel exclusively remote randomized clinical trial (ClinicalTrials.gov NCT04354428) of hydroxychloroquine and azithromycin for the treatment of the SARS-CoV-2–mediated COVID-19 disease which included cardiovascular safety monitoring. All study activities were conducted remotely. Self-collected vital signs (temperature, respiratory rate, heart rate, and oxygen saturation) and electrocardiographic (ECG) measurements were transmitted digitally to investigators while mid-nasal swabs for SARS-CoV-2 testing were shipped. ECG collection relied on a consumer device (KardiaMobile 6L, AliveCor Inc.) that recorded and transmitted six-lead ECGs via participants’ internet-enabled devices to a central core laboratory, which measured and reported QTc intervals that were then used to monitor safety. Results Two hundred and thirty-one participants uploaded 3245 ECGs. Mean daily adherence to the ECG protocol was 85.2% and was similar to the survey and mid-nasal swab elements of the study. Adherence rates did not differ by age or sex assigned at birth and were high across all reported race and ethnicities. QTc prolongation meeting criteria for an adverse event occurred in 28 (12.1%) participants, with 2 occurring in the placebo group, 19 in the hydroxychloroquine group, and 7 in the hydroxychloroquine + azithromycin group. Conclusions Our report demonstrates that digital health technologies can be leveraged to conduct rigorous, safe, and entirely remote clinical trials.
Chronic unhealthy levels of alcohol use, may predispose adults to use illicit substances and/or modify their response to prescribed medications, such as pain medications. We examined the cognitive and side effect response of older adults who met criteria for healthy and unhealthy alcohol drinking patterns after exposure to 10mg of oxycodone. Using a human laboratory model, eligible participants were characterized on cognitive, side effect measures and cold-pressor pain test (CPT) at baseline and repeated 90 minutes, 3 and 5 hours post dosing (10mg oxycodone). Blood samples were taken at regular intervals to measure drug levels. One-hundred twenty-five adults completed the study day, eighty participants with heavy alcohol consumption and 45 with healthy. Middle age (MA) group had a mean age of 51 (11.2) years, older adults (OA) 72 (4.2) years. Between group (unhealthy vs healthy drinkers, middle age vs older adult) comparisons for cognitive performance indicate a significant decline at 90 min. However, MA and OA heavy alcohol consumers evidenced less decline on sustained attention (D2) and working memory, but more decline on a measure of balance (berg). Anti-nocioceptive effects were greatest in healthy (MA,OA) in comparison to heavy, however there were no differences on pupil miosis. Subjective rating of side effects were rated more severe in the OA unhealthy group compared to MA and healthy. These findings indicate unhealthy alcohol consumption attenuates the impact of opioid medication. Results indicate that alcohol consumption patterns should be considered when using opioids in older and middle age adults.
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