30-to-90 Day Challenge: Effects of Alcohol Cessation on Health Outcomes
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|ClinicalTrials.gov Identifier: NCT03353701|
Recruitment Status : Recruiting
First Posted : November 27, 2017
Last Update Posted : June 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Drinking Chronic Inflammation Neurocognitive Dysfunction Liver Diseases HIV Infections||Behavioral: Contingency Management (CM)||Not Applicable|
This proposed study continues a line of research by Doctors Cohen, Cook, Kahler, and colleagues on heavy alcohol use, HIV-associated brain dysfunction, and long-term HIV outcomes. The study will build on our past findings to determine the extent to which marked reductions in alcohol consumption at 30 days and again at 90 days via contingency management (CM) improves cognitive-behavioral performance, underlying brain functions and pathophysiology, and HIV-associated health outcomes. This feature in itself is a novel contribution and has rarely been done, but more importantly, it reflects the mission of the collaboration to develop actionable data on clinical trajectories in HIV infected heavy drinkers over age 50 that will instill high confidence in guiding next therapeutic steps. The study team will obtain a better understanding of how persons with HIV stop drinking, and what factors influence long-term drinking changes. These important clinical and scientific questions need resolution for successful treatment and management of HIV+ adults. This study is motivated by evidence that HIV-associated neurocognitive dysfunction continues despite effective combined anti-retroviral therapies (cART). Even mild cognitive impairments have detrimental functional effects and health outcomes that worsen as HIV+ people age. Heavy alcohol consumption is common among HIV+ adults, and contributes to functional brain disturbances directly or indirectly via systemic metabolic or inflammatory disturbances. However, our past findings indicate that current alcohol use is more strongly associated with cognitive and brain dysfunction among HIV+ adults than lifetime consumption; and that adverse brain effects occur primarily with heavy drinking. Our overarching hypothesis is that the impact of ongoing heavy alcohol use on the brain and cognition may be reversible, providing a strong impetus for the proposed study. The study team will conduct our research in Florida, which has the highest number of new HIV infections in the US, as well as an increasingly diverse population with HIV+, 50% of whom are now aged 50 years or over in the state.
Our research will seek to modify alcohol consumption by using contingency management (CM) and measure for changes in brain pathophysiology and function, as well as changes in systemic inflammation, and gut and liver pathologies which are hypothesized pathways by which alcohol may increase brain dysfunction. The study team will also measure neurocognitive functioning related to learning, attention-executive functions, working memory, and processing speed, domains in which HIV+ persons experience persistent impairment. the study team will use Motivational Interviewing (MI) to learn more about how persons with and without HIV reduce drinking, what factors are associated with long-term drinking changes, and how these drinking changes influence HIV clinical health behavior and outcomes. If the impact of alcohol on systemic and cerebral inflammation is temporary, then reducing or eliminating alcohol consumption could dramatically improve cognitive function and indices of brain health, even among people who have consumed alcohol for many years in the past. Our research will directly test hypotheses that ongoing heavy alcohol consumption is associated with brain pathophysiology and inflammation that impairs both functioning and cognitive processing, and that the inflammation and its sequelae are reversible in most HIV+ persons with alcohol cessation. The proposed sample will be 140 adults with HIV infection and 40 adults without HIV infection (at least 25% female; age >50 years). Participants will be recruited from heavy drinkers (>=14 drinks/week women, >=21 drinks/week men) with HIV infection identified from our ongoing Florida Cohort. HIV- participants will be recruited from community medical clinics where flyers will be posted.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Participants will serve as their own controls with pre- and post-measures.|
|Masking:||None (Open Label)|
|Official Title:||Effects of Experimentally-induced Reductions in Alcohol Consumption on Brain Cognitive and Clinical Outcomes, and Motivation for Changing Drinking in Older Persons With HIV Infection|
|Actual Study Start Date :||December 11, 2017|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||December 2020|
Adults with or without HIV infection
Participants will be asked to stop drinking for at least 30 and up to 90 days. The study will use Contingency Management (CM) with financial incentives to encourage participants to maximally reduce alcohol consumption.
Behavioral: Contingency Management (CM)
A reinforcement delivery method that involves financial incentive to participants for sustained alcohol abstinence. CM will start after the participants complete the baseline measures and last for at least 30 days and up to 90 days.
- Change in Neurocognitive Functions [ Time Frame: Baseline, 30 Days ]Change in cognitive performance from baseline to 30-day follow-up. NIH Toolbox Cognition Battery is administered by a research assistant and consists of seven tests assessing memory, attention, cognitive flexibility, processing speed, and executive functioning. Summary scores will be calculated.
- Change in Neuroinflammation [ Time Frame: Baseline, 30 Days ]Change in brain inflammation from baseline to 30-day follow-ups. Neuroinflammation is measured by cerebral metabolic neuroinflammatory markers, which include Magnetic Resonance Spectroscopy (MRS) metabolite concentrations (Cho and Myo-Inositol) and extracellular free water from Diffusor Tension Imaging sequences (DTI-FW).
- Change in Brain Function [ Time Frame: Baseline, 30 Days ]Change in Brain Function from baseline to 30-day follow-up. Brain function is measured by mean signal intensity for specific task-dependent brain regions from functional magnetic resonance imaging (fMRI).
- Change in markers of systemic Inflammation [ Time Frame: 30 Days ]Blood testing for biomarkers of systemic inflammation such as cytokines, ceramides, FIB-4, and marker of abnormal liver function.
- Change in liver Status [ Time Frame: 30 Days ]Evidence of liver fibrosis, fatty liver, and liver inflammation as measured by fibroscan
- Change in Drinks/week in the Past 30 Days [ Time Frame: Baseline, 1 Year ]Change in number of standard drinks per week in the past 30 days from baseline to 1 year follow-up, calculated from Timeline Follow Back (TLFB) interview.
- Change in gut microbiome [ Time Frame: Baseline, 30-days, 90-days, 1 year ]Change in the ratio of Firmicutes: Bacteriodetes ratio, and change in the relative abundance of Proteobacteria
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03353701
|Contact: Robert Cook, MD, MPHemail@example.com|
|Contact: Katie firstname.lastname@example.org|
|United States, Florida|
|University of Miami||Recruiting|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Robert Cook||University of Florida|
|Principal Investigator:||Ronald Cohen||University of Florida|