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NCT03353701 · ClinicalTrials.gov registry record · NA
30-to-90 Day Challenge: Effects of Alcohol Cessation on Health Outcomes
A NA study, sponsored by University of Florida.
- Completed
- Registry status
- NA
- Development phase
- 57
- Enrollment target
NCT03353701 is a NA study that has completed, run by University of Florida. The registered enrollment target is 57 participants.
The verdict
NCT03353701, a NA study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- NA
- Development phase
- 57 participants
- Enrollment target
Study Summary
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, an
Interventions
- BEHAVIORAL Contingency Management (CM)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2017-12-11 |
| Est. Completion | 2024-01-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03353701
The ClinicalTrials.gov registry entry for NCT03353701 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Contingency Management (CM) is the first listed.
NCT03353701 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03353701 about?
NCT03353701 is a clinical study titled "30-to-90 Day Challenge: Effects of Alcohol Cessation on Health Outcomes". 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 ...
What is the current status of trial NCT03353701?
This trial is currently completed. It is a NA study. The enrollment target is 57 participants. The study started on 2017-12-11. Estimated completion is 2024-01-01.
What interventions are being tested in trial NCT03353701?
The interventions under investigation include: Contingency Management (CM) (BEHAVIORAL).
Who is sponsoring clinical trial NCT03353701?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
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