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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: Completed NA study, sponsored by University of Florida.
NCT03353701 is a NA study that has completed, run by University of Florida. The registered enrollment target is 57 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
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.
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 |
What the finished NCT03353701 record still lists
NCT03353701 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Contingency Management (CM) is the first listed.
NCT03353701 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03353701's enrollment target sits among peer trials
57 1261st of 2000 higher than 739 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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