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NCT04391816 · ClinicalTrials.gov registry record
COVID-19 Pandemic Impact on Alcohol (PIA) - A Natural History Study
A clinical trial of Alcohol Drinking and Alcohol-Related Disorders, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- Recruiting
- Registry status
- 1,500
- Enrollment target
- 1
- Study location
NCT04391816: Recruiting study of Alcohol Drinking and Alcohol-Related Disorders, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
NCT04391816 is a study of Alcohol Drinking and Alcohol-Related Disorders that is actively recruiting participants, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 1,500 participants, above the 613-participant average among 85 other Alcohol Drinking trials with a reported enrollment target (145% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04391816, a study of Alcohol Drinking and Alcohol-Related Disorders, is actively recruiting participants, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- RECRUITING
- Registry status
- 1,500 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: The SARS-CoV-2 virus has caused a pandemic infection called COVID-19. It is a global threat to people, communities, and health systems. Researchers are concerned about the mental health effects of the pandemic. They want to learn more about how it is affecting people s alcohol use and problems, and how it may continue to affect them over time. Objective: To study the impact of the COVID-19 pandemic on alcohol use and consequences in individuals across the spectrum of alcohol use and those with alcohol use disorder. Eligibility: Participants who have been screened under the NIAAA Screening, Assessment and Management Protocol (14-AA-0181) Design: Participants will complete a baseline survey by phone. It will ask about alcohol use, alcohol dependence, and stress. It covers 2 time periods: the 12 months before the pandemic started and the time since it started. Participants will get an ID code and a link to an online survey. They will complete the online survey within a week of the phone survey. Participants will complete a series of online surveys over 24 months. For the first year, surveys will be completed weekly for the first 4 weeks, then biweekly for the next 8 weeks, and then every 1-2 months for the rest of the year. For the second year, surveys will be completed every 6 months. Surveys will cover the following topics: * Alcohol use and its consequences * Other substance use * Stress * Impact of the COVID-19 pandemic * Pain * Physical health * Sleep * Quality of life. Because the course of the pandemic may change, the frequency of the surveys may change. Participation lasts 2 years.
Primary Outcome
Alcohol Use Disorder Identification Test (AUDIT): This is a 10-item questionnaire designed to screen for AUD. The first 3 questions constitute the AUDIT-C and provides a measure of alcohol consumption. The total score provides a continuous quantification of AUD severity.
Conditions Studied
Study Locations (1)
Maryland
- NIAAA Section on Human Psychopharmacology - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,500 participants |
| Start Date | 2020-06-03 |
| Est. Completion | 2026-12-31 |
What NCT04391816 shows while recruiting
NCT04391816 is an observational study that tracks outcomes without assigning an intervention. Its 1,500 participants enrollment target places it among the larger protocols in the corpus, above the 613-participant average among 85 other Alcohol Drinking trials with a reported enrollment target (145% higher).
The record links to 4 conditions, with Alcohol Drinking appearing as the primary indexed condition, and to 0 interventions.
NCT04391816 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04391816 about?
NCT04391816 is a clinical study titled "COVID-19 Pandemic Impact on Alcohol (PIA) - A Natural History Study". Background: The SARS-CoV-2 virus has caused a pandemic infection called COVID-19. It is a global threat to people, communities, and health systems. Researchers are concerned about the mental health effects of the pandemic. They want to learn more about how it is affecting people s alcohol use and p...
What is the current status of trial NCT04391816?
This trial is currently recruiting. The enrollment target is 1,500 participants. The study started on 2020-06-03. Estimated completion is 2026-12-31.
What conditions does trial NCT04391816 study?
This clinical trial studies the following conditions: Alcohol Drinking, Alcohol-Related Disorders, Psychological Stress, Pandemic.
Who is sponsoring clinical trial NCT04391816?
This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04391816 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alcohol Drinking
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04391816's enrollment target sits among peer trials
1,500 5th of 85 higher than 81 of 85 other Alcohol Drinking trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcohol Drinking 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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