NCT04391816

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

Recruiting now Last updated 14 January 2026

What this trial tests

trial in Alcohol Drinking in 1,500 participants. Currently enrolling.

Timeline

3 June 2020

Primary endpoint
31 December 2026

31 December 2026

Quick facts

Lead sponsor	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	1,500
Start date	3 June 2020
Primary completion	31 December 2026
Estimated completion	31 December 2026
Sites	1 location across United States

Conditions studied

• Alcohol Drinking — all drugs for Alcohol Drinking →
• Alcohol-Related Disorders — all drugs for Alcohol-Related Disorders →
• Pandemic — all drugs for Pandemic →
• Psychological Stress — all drugs for Psychological Stress →

Sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Who can join

Adults 18 to 100, any sex, with Alcohol Drinking or Alcohol-Related Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. A person-centered approach to capture health disparities and multidimensional impact of COVID-related stressors.
   Luk JW, Stangl BL, Schwandt ML, Gunawan T, et al · · 2023 · cited 24× · PMID 36006708 · DOI 10.1037/amp0001044
2. Changes in Alcohol-Related Behaviors and Quality of Life During the COVID-19 Pandemic: Impact of Alcohol Use Disorder Diagnosis and Treatment History.
   Luk JW, Stangl BL, Gunawan T, Schwandt ML, et al · · 2022 · cited 12× · PMID 36350598 · DOI 10.4088/jcp.22br14462
3. Chemosensory Alterations and Impact on Quality of Life in Persistent Alcohol Drinkers.
   Agarwal K, Luk JW, Manza P, McDuffie C, et al · · 2023 · cited 10× · PMID 36208183 · DOI 10.1093/alcalc/agac047
4. Associations of history of alcohol use disorder with loneliness, social support, and mental health during the COVID-19 pandemic.
   Luk JW, Leiter N, Stangl BL, Gunawan T, et al · · 2024 · cited 9× · PMID 38479194 · DOI 10.1016/j.psychres.2024.115826
5. Exercising healthy behaviors: A latent class analysis of positive coping during the COVID-19 pandemic and associations with alcohol-related and mental health outcomes.
   McCabe EM, Luk JW, Stangl BL, Schwandt ML, et al · · 2024 · cited 5× · PMID 38354113 · DOI 10.1371/journal.pone.0297060
6. Drinking motives link positive and negative life events to problematic alcohol use during the COVID-19 pandemic: a longitudinal study.
   Geda DW, Stangl BL, Arsenault A, Thompson MF, et al · · 2024 · cited 3× · PMID 39367531 · DOI 10.1093/alcalc/agae068
7. Parosmia Is Positively Associated With Problematic Drinking, as Is Phantosmia With Depressive Symptoms.
   Agarwal K, Luk JW, Stangl BL, Schwandt ML, et al · · 2024 · cited 3× · PMID 38776446 · DOI 10.1097/adm.0000000000001332
8. Treatment access gap during the COVID-19 Pandemic: impact on problematic alcohol use and the moderating roles of perceived stress and resilience.
   Vergeer RR, Luk JW, Stangl BL, McCabe EM, et al · · 2024 · cited 2× · PMID 39735429 · DOI 10.3389/fpsyt.2024.1487277