Experimentally Induced Reductions in Alcohol Consumption and Brain, Cognitive, and Clinical Outcomes in Older Persons With and Those Without HIV Infection (30-Day Challenge Study): Protocol for a Nonrandomized Clinical Trial Article Swipe
YOU?
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· 2023
· Open Access
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· DOI: https://doi.org/10.2196/53684
Background Both alcohol consumption and HIV infection are associated with worse brain, cognitive, and clinical outcomes in older adults. However, the extent to which brain and cognitive dysfunction is reversible with reduction or cessation of drinking is unknown. Objective The 30-Day Challenge study was designed to determine whether reduction or cessation of drinking would be associated with improvements in cognition, reduction of systemic and brain inflammation, and improvement in HIV-related outcomes in adults with heavy drinking. Methods The study design was a mechanistic experimental trial, in which all participants received an alcohol reduction intervention followed by repeated assessments of behavioral and clinical outcomes. Persons were eligible if they were 45 years of age or older, had weekly alcohol consumption of 21 or more drinks (men) or 14 or more drinks (women), and were not at high risk of alcohol withdrawal. After a baseline assessment, participants received an intervention consisting of contingency management (money for nondrinking days) for at least 30 days followed by a brief motivational interview. After this, participants could either resume drinking or not. Study questionnaires, neurocognitive assessments, neuroimaging, and blood, urine, and stool samples were collected at baseline, 30 days, 90 days, and 1 year after enrollment. Results We enrolled 57 persons with heavy drinking who initiated the contingency management protocol (mean age 56 years, SD 4.6 years; 63%, n=36 male, 77%, n=44 Black, and 58%, n=33 people with HIV) of whom 50 completed 30-day follow-up and 43 the 90-day follow-up. The planned study procedures were interrupted and modified due to the COVID-19 pandemic of 2020-2021. Conclusions This was the first study seeking to assess changes in brain (neuroimaging) and cognition after alcohol intervention in nontreatment-seeking people with HIV together with people without HIV as controls. Study design strengths, limitations, and lessons for future study design considerations are discussed. Planned analyses are in progress, after which deidentified study data will be available for sharing. Trial Registration ClinicalTrials.gov NCT03353701; https://clinicaltrials.gov/study/NCT03353701 International Registered Report Identifier (IRRID) DERR1-10.2196/53684
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- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.2196/53684
- OA Status
- gold
- References
- 57
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4388523901
Raw OpenAlex JSON
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https://openalex.org/W4388523901Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.2196/53684Digital Object Identifier
- Title
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Experimentally Induced Reductions in Alcohol Consumption and Brain, Cognitive, and Clinical Outcomes in Older Persons With and Those Without HIV Infection (30-Day Challenge Study): Protocol for a Nonrandomized Clinical TrialWork title
- Type
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articleOpenAlex work type
- Language
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enPrimary language
- Publication year
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2023Year of publication
- Publication date
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2023-11-09Full publication date if available
- Authors
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Robert L. Cook, Veronica L. Richards, Joseph M. Gullett, Brenda Lerner, Zhi Zhou, Eric C. Porges, Yan Wang, Christopher W. Kahler, Nancy P. Barnett, Zhigang Li, Suresh Pallikkuth, Emmanuel Thomas, Allan Rodríguez, Kendall Bryant, Smita Ghare, Shirish Barve, Varan Govind, Jessy G. Dévieux, Ronald A. CohenList of authors in order
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YesWhether a free full text is available
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goldOpen access status per OpenAlex
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https://doi.org/10.2196/53684Direct OA link when available
- Concepts
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Medicine, Cognition, Clinical trial, Human immunodeficiency virus (HIV), Alcohol consumption, Protocol (science), Effects of sleep deprivation on cognitive performance, Randomized controlled trial, Cognitive decline, Psychiatry, Alcohol, Gerontology, Dementia, Internal medicine, Family medicine, Alternative medicine, Disease, Biochemistry, Pathology, ChemistryTop concepts (fields/topics) attached by OpenAlex
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0Total citation count in OpenAlex
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10Other works algorithmically related by OpenAlex
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| referenced_works | https://openalex.org/W2521342226, https://openalex.org/W2770823248, https://openalex.org/W2460166417, https://openalex.org/W2153858533, https://openalex.org/W2251454683, https://openalex.org/W2899221401, https://openalex.org/W2516366771, https://openalex.org/W2271639429, https://openalex.org/W3097638062, https://openalex.org/W2581389537, https://openalex.org/W2013595983, https://openalex.org/W2040002999, https://openalex.org/W3137127954, https://openalex.org/W2728731909, https://openalex.org/W2008320988, https://openalex.org/W1985451137, https://openalex.org/W2790172508, https://openalex.org/W2043880809, https://openalex.org/W2165758561, https://openalex.org/W2011410195, https://openalex.org/W1475474724, https://openalex.org/W2172151487, https://openalex.org/W2059251460, https://openalex.org/W1489249390, https://openalex.org/W2151487996, https://openalex.org/W1544644153, https://openalex.org/W2043705607, https://openalex.org/W2132322340, https://openalex.org/W2375701190, https://openalex.org/W2269592175, https://openalex.org/W2320909684, https://openalex.org/W2060468894, https://openalex.org/W2098658501, https://openalex.org/W2028013615, https://openalex.org/W2092926615, https://openalex.org/W1858508207, https://openalex.org/W4296295377, https://openalex.org/W2120357670, https://openalex.org/W2044726369, https://openalex.org/W4296086374, https://openalex.org/W2035258898, https://openalex.org/W2134551595, https://openalex.org/W2169232412, https://openalex.org/W2784551971, https://openalex.org/W2116823839, https://openalex.org/W2166311155, https://openalex.org/W2058363360, https://openalex.org/W2580488783, https://openalex.org/W2919596485, https://openalex.org/W2167883938, https://openalex.org/W3013503722, https://openalex.org/W2110065044, https://openalex.org/W2005322823, https://openalex.org/W228126680, https://openalex.org/W2140205353, https://openalex.org/W2000900774, https://openalex.org/W2370820144 |
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