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NCT04380116 · ClinicalTrials.gov registry record · NA
Preliminary Effectiveness of Remotely Monitored Blood Alcohol Concentration Device as Treatment Modality
A NA study, sponsored by Yale University.
- Completed
- Registry status
- NA
- Development phase
- 96
- Enrollment target
NCT04380116: Completed NA study, sponsored by Yale University.
NCT04380116 is a NA study that has completed, run by Yale University. The registered enrollment target is 96 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04380116, a NA study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- NA
- Development phase
- 96 participants
- Enrollment target
Study Summary
State the scientific aim(s) of the study, or the hypotheses to be tested. The purpose of the current study is to evaluate the usage and acceptability of the Soberlink's blood alcohol concentration (BAC) unit in collaboration with Aware treatment to assess increased sobriety within patients suffering from alcohol use disorder (AUD). The specific AIMS will be: 1. To determine the effectiveness of Soberlink's ability to increase abstinence 2. To evaluate the impact of Soberlink's device on the participant based on their quality of health and sobriety. 3. To evaluate the extent to which need for higher levels of follow-up care and treatment is reduced for individuals who have had access to the Soberlink device.
Primary Outcome
The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time (previous month). The Alcohol TLFB allows several dimensions of a person's drinking to be separately examined: (a) variability (i.e., scatter); (b) pattern (i.e., shape); and (c) extent of drinking (i.e., elevation; how much).
Interventions
- DEVICE Soberlink
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2020-06-29 |
| Est. Completion | 2022-05-01 |
| Phase | NA |
What the finished NCT04380116 record still lists
NCT04380116 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Soberlink is the first listed.
NCT04380116 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04380116 about?
NCT04380116 is a clinical study titled "Preliminary Effectiveness of Remotely Monitored Blood Alcohol Concentration Device as Treatment Modality". State the scientific aim(s) of the study, or the hypotheses to be tested. The purpose of the current study is to evaluate the usage and acceptability of the Soberlink's blood alcohol concentration (BAC) unit in collaboration with Aware treatment to assess increased sobriety within patients suffering...
What is the current status of trial NCT04380116?
This trial is currently completed. It is a NA study. The enrollment target is 96 participants. The study started on 2020-06-29. Estimated completion is 2022-05-01.
What interventions are being tested in trial NCT04380116?
The interventions under investigation include: Soberlink (DEVICE).
Who is sponsoring clinical trial NCT04380116?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04380116's enrollment target sits among peer trials
96 925th of 2000 higher than 1,070 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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