Cook Robert L, Richards Veronica L, Gullett Joseph M, Lerner Brenda D G, Zhou Zhi, Porges Eric C, Wang Yan, Kahler Christopher W, Barnett Nancy P, Li Zhigang, Pallikkuth Suresh, Thomas Emmanuel, Rodriguez Allan, Bryant Kendall J, Ghare Smita, Barve Shirish, Govind Varan, Dévieux Jessy G, Cohen Ronald A
Southern HIV and Alcohol Research Consortium, University of Florida, Gainesville, FL, United States.
Edna Bennett Pierce Prevention Research Center, The Pennsylvania State University, University Park, PA, United States.
JMIR Res Protoc. 2024 Apr 2;13:e53684. doi: 10.2196/53684.
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.
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.
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.
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.
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.
ClinicalTrials.gov NCT03353701; https://clinicaltrials.gov/study/NCT03353701.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/53684.
饮酒和感染艾滋病毒均与老年人更差的大脑、认知及临床结局相关。然而，饮酒量减少或戒酒能否使大脑和认知功能障碍得到改善尚不清楚。
“30天挑战”研究旨在确定饮酒量减少或戒酒是否会使大量饮酒的成年人在认知、全身及大脑炎症减轻以及与艾滋病毒相关的结局方面得到改善。
该研究设计为一项机制性实验性试验，所有参与者均接受饮酒量减少干预，随后对行为和临床结局进行重复评估。符合条件者年龄在45岁及以上，每周饮酒量男性为21杯或更多，女性为14杯或更多，且不存在酒精戒断的高风险。在进行基线评估后，参与者接受为期至少30天的应急管理干预（不饮酒日给予金钱奖励），随后进行简短的动机性访谈。此后，参与者可以选择恢复饮酒或不饮酒。在入组后的基线、30天、90天和1年时收集研究问卷、神经认知评估、神经影像学以及血液、尿液和粪便样本。
我们招募了57名大量饮酒者，他们启动了应急管理方案（平均年龄56岁，标准差4.6岁；63%，n = 36为男性，77%，n = 44为黑人，58%，n = 33为艾滋病毒感染者），其中50人完成了30天随访，43人完成了90天随访。由于2020 - 2021年的新冠疫情，原计划的研究程序被中断并进行了修改。
这是第一项旨在评估艾滋病毒感染者和非艾滋病毒感染者（作为对照）在酒精干预后大脑（神经影像学）和认知变化的研究。讨论了研究设计的优势、局限性以及对未来研究设计考虑的经验教训。正在进行计划中的分析，之后将提供去识别化的研究数据以供分享。
ClinicalTrials.gov NCT03353701；https://clinicaltrials.gov/study/NCT03353701。
国际注册报告识别码（IRRID）：DERR1 - 10.2196/53684。
