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COVID-19 Pandemic Impact on Alcohol (PIA) - A Natural History Study

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 321 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. 2 versions Re-verified since Apr 25, 2026, no change to tracked fieldsv320-v321
  2. Primary and study completion dates: Dec 31, 2025 to Dec 31, 2026v319
  3. 5 versions Re-verified since Mar 22, 2025, no change to tracked fieldsv314-v318
  4. Primary and study completion dates: Dec 31, 2024 to Dec 31, 2025v313
  5. Re-verified, no change to tracked fieldsv312
Show 40 earlier versionsHide 40 earlier versions
  1. Eligibility criteria expanded, about 20 words
    • Study description expanded, about 1 word
    v311
  2. Re-verified, no change to tracked fieldsv310
  3. Study description expanded, about 37 wordsv309
  4. 2 versions Re-verified since Jan 26, 2024, no change to tracked fieldsv307-v308
  5. Enrollment target: 700 to 1500v306
  6. 34 versions Re-verified since May 17, 2022, no change to tracked fieldsv272-v305
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04391816
Lead Sponsor National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions
(from sponsor)		 Alcohol Drinking, Alcohol-Related Disorders, Pandemic, Psychological Stress
Related terms Alcohol Drinking, Alcohol-Related Disorders, Alcoholism, Coronavirus Infections, Social Isolation, Stress, Psychological
Enrollment 1,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov