NCT03353701Completed
30-to-90 Day Challenge: Effects of Alcohol Cessation on Health Outcomes
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
Source: ClinicalTrials.gov · Last updated 3 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 57 (actual)
- First submitted
- 3 Nov 2017
- Start date
- 11 Dec 2017
- Primary completion date
- 1 Aug 2022
- Lead sponsor
- University of Florida
- Diseases
- HIV
- NCT number
- NCT03353701
What you commit to
- Study type: Interventional
- Participants enrolled: 57
- From 11 Dec 2017 to the primary completion date, 1 Aug 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- MRI contraindications (e.g., pregnancy, severe claustrophobia, metal implants).
Other illness
- Neurological disorders (e.g., dementia, stroke, seizures, traumatic brain injury).
- Evidence of dementia (MOCA \< 17).
- Past opportunistic brain infection
- Major psychiatric illness (schizophrenia, intractable affective disorder, current substance dependence diagnosis).
- Current major psychiatric disturbance, including severe major depression.
- Unstable medical conditions (e.g., cancer).
- Physical impairment precluding motor response or lying still.
- Significant history of alcohol withdrawal as indicated by an Alcohol Withdrawal Symptom Checklist score ≥ 23 (within past year).
Other
- Unable to correctly answer a set of questions that demonstrate understanding of key aspects of the study, including the voluntary nature of the study, the purpose of the study, what participants are being asked to do as part of the study, and what are the risks related to participating in the study.
Who the study is looking for
- Men and women;
- Age: 50-75 yrs.;
- 140 participants will have confirmed HIV (confirmed via baseline bloodwork) and 40 participants will be HIV negative
- English speaking (will have protocol ready in Spanish in 2017);
- Physically mobile;
- Willing to participate in CM to reduce alcohol consumption, and to wear the alcohol biosensor for at least 30 days. All participants will be current, heavy drinkers (\>=14 drinks/week women, \>=21 drinks/week men), confirmed by baseline timeline follow-back, and by having evidence of at least 3 drinking episodes on the alcohol biosensor prior to baseline). Must blow a "zero" on breathalyzer at time of informed consent
Age in the registry: 50 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Miami Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.