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.

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.

Publication date: Apr 02, 2024

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. DERR1-10. 2196/53684.

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Concepts Keywords
Alcohol alcohol
Clinicaltrials biosensor
Hiv cognitive function
Nct03353701 contingency management
Weekly HIV infection


Type Source Name
drug DRUGBANK Ethanol
disease MESH HIV Infection
pathway REACTOME HIV Infection
disease VO protocol
disease MESH cognitive dysfunction
disease MESH brain inflammation
disease VO study design
disease IDO intervention
disease IDO blood
disease MESH COVID-19 pandemic
drug DRUGBANK Methylphenidate
drug DRUGBANK Dapsone
drug DRUGBANK Etodolac
disease MESH Alcohol Addiction
disease MESH AIDS
pathway KEGG Alcoholism
disease MESH liver disease
disease MESH inflammation
disease MESH dysbiosis
disease VO effectiveness
disease VO effective
disease VO population
disease MESH fibrosis
drug DRUGBANK Spinosad
disease VO report
disease MESH neurological disorders
disease MESH dementia
disease MESH stroke
disease MESH seizures
disease MESH opportunistic infection
disease MESH cancer
disease MESH contraindications
disease MESH claustrophobia
disease IDO symptom
disease VO device
drug DRUGBANK Water
disease VO age
disease IDO country
disease IDO history
disease MESH Marital status
disease VO time
disease VO vaccination
disease MESH Sleep quality
disease MESH Anxiety Disorder
disease MESH Posttraumatic stress disorder
disease MESH Childhood trauma
disease VO frequency
disease VO injection
drug DRUGBANK Methionine
disease MESH somnolence
drug DRUGBANK Etoperidone
disease IDO production
drug DRUGBANK gamma-Aminobutyric acid
drug DRUGBANK 1-naphthaleneacetic acid
drug DRUGBANK Creatine
drug DRUGBANK Choline
drug DRUGBANK Inositol
disease MESH neuroinflammation
disease MESH hepatitis
drug DRUGBANK Cocaine
drug DRUGBANK Metamfetamine
drug DRUGBANK Oxycodone
disease VO Bacteroidota
disease MESH fatty liver
drug DRUGBANK Dronabinol
drug DRUGBANK Midomafetamine
drug DRUGBANK Phencyclidine

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