An interventional study of Contingency Management (CM) in Alcohol Drinking, Chronic Inflammation and Neurocognitive Dysfunction, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 50 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-03.
Sponsored by University of Florida · Not applicable, Interventional, and Other
The objective for this project is to determine whether how certain behavioral and health functions change in persons with heavy drinking when they stop (or reduce) drinking for 30 days, and whether changes continue for up to 90 days. The study will also identify barriers and facilitators related to drinking reduction. The project will focus on clinical comorbidities including HIV disease control, cognitive and brain function, liver abnormalities, and chronic inflammation. The study teams propose to enroll 140 HIV+ and 40 HIV- adults with heavy drinking, and then use Contingency Management (CM) with financial incentives to encourage participants to maximally reduce alcohol consumption for 30 days. Participants will be required to wear an ankle biosensor (SCRAM monitor) at all times, which is used to monitor participants' drinking behavior. At 30 days, participants will complete a full day of follow-up, including cognitive testing, neuroimaging, blood testing, liver Fibroscan, and questionnaires. Many participants will also provide a stool sample for gut microbiome assessment at each time point. At 30 days, participants will participate in a motivational interview to discuss perceived benefits and obstacles to drinking reduction, and most participants will continue CM to 90 days (but can opt out at this point). Participants will complete another full-day assessment at 90 days, at which point persons may choose to drink or not on their own (no more CM). A final assessment will be conducted at 12 months. This A-B-A design will enable us to clearly identify whether alcohol effects on cognition and brain function are reversible in the context of HIV, and analyze specific cerebral and systemic pathophysiological factors contributing to these effects. The inclusion of HIV- adults will enable subgroup comparisons of alcohol reduction effects in the context of HIV vs. no-HIV. These HIV-negative participants will be recruited from the same settings as our HIV+ participants, and will include a similar proportion by age, race, and gender as the HIV+ participants. The study team will use information from the MI data and our other assessments to elucidate factors that predict both short term (during CM) and long-term (1-year) alcohol reductions, and study how changes in alcohol consumption affect important HIV clinical outcomes that will be monitored over time.
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.
701 studies on the registry are indexed under Alcohol Drinking; 133 are open to participants now.
This study's enrollment of 57 is below the median of 122 across 607 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.
Compared within Alcohol Drinking, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Time frame: Baseline, 30 Days
Change in Neuroinflammation
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).
Time frame: Baseline, 30 Days
Change in Brain Function
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).
Time frame: Baseline, 30 Days
Change in markers of systemic Inflammation
Blood testing for biomarkers of systemic inflammation such as cytokines, ceramides, FIB-4, and marker of abnormal liver function.
Time frame: 30 Days
Change in liver Status
Evidence of liver fibrosis, fatty liver, and liver inflammation as measured by fibroscan
Time frame: 30 Days
Change in Drinks/week in the Past 30 Days
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.
Time frame: Baseline, 1 Year
Change in gut microbiome
Change in the ratio of Firmicutes: Bacteriodetes ratio, and change in the relative abundance of Proteobacteria
Time frame: Baseline, 30-days, 90-days, 1 year
Plan to share: Yes — Limited and de-identified datasets will be available to researchers after signing a data-use agreement with the University of Florida.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Our documents can be shared once the study begins. Data sharing will be an option for at least 5 years after the study is completed.
Access criteria: Contact the principal investigator. In the future, information about how to request data will be on a public website
Data sharing details ↗ · sharc-research.org
No publications or documents are linked to this record.
Ran from Dec 2017 to primary completion in Aug 2022, 55 months.
Of 328 non-industry interventional studies with no phase under Alcohol Drinking, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's 55 months is above that.
Counting every sponsor, half of 336 studies reached it within 24 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.