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

NCT04391816 | Recruiting

• 2 other identifiers: 20011520-AA-0115
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcohol-Related Disorders; Pandemic; Psychological Stress; Alcohol Drinking

Keywords

Coronavirus; Alcohol Use Disorder; SARS-CoV2; Stress; Social Isolation; Natural History

Outcome Measures

Primary Outcomes (2)

• AUDIT Score

  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.

  24 months

• ADS Score

  Alcohol Dependence Scale (ADS): This 25-item scale will be used to measure severity of alcohol dependence. This scale covers alcohol withdrawal symptoms, impaired control over drinking, awareness of a compulsion to drink, increased tolerance to alcohol, and salience of drink-seeking behavior.

  24 months

Secondary Outcomes (3)

• Life Events Questionnaire (LEQ) Score

  24 monhts

• UCLA Loneliness Scale (UCLA-LS) Score

  24 months

• Perceived Stress Scale (PSS) Score

  24 months

Study Arms (1)

Study Participants

Participants that were previously enrolled in the NIAAA Screening Protocol.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target population for this study includes healthy adults across the spectrum of alcohol use who have been screened under the NIAAA screening protocol (14-AA-0181). This sample includes non-drinkers, light drinkers, non-treatment-seeking heavy drinkers, and treatment-seeking individuals with alcohol use disorder.

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Participants who have enrolled in the NIAAA Natural History Protocol (14-AA-0181) and completed screening and phenotyping assessments.
• Willing and able to complete frequent (weekly to monthly) surveys either online or by phone.

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA): lead

Study Sites (1)

NIAAA Section on Human Psychopharmacology

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (5)

• Cerda M, Tracy M, Galea S. A prospective population based study of changes in alcohol use and binge drinking after a mass traumatic event. Drug Alcohol Depend. 2011 May 1;115(1-2):1-8. doi: 10.1016/j.drugalcdep.2010.09.011. Epub 2010 Oct 24.

  PMID: 20977977 BACKGROUND

• Druss BG. Addressing the COVID-19 Pandemic in Populations With Serious Mental Illness. JAMA Psychiatry. 2020 Sep 1;77(9):891-892. doi: 10.1001/jamapsychiatry.2020.0894. No abstract available.

  PMID: 32242888 BACKGROUND

• Clay JM, Parker MO. Alcohol use and misuse during the COVID-19 pandemic: a potential public health crisis? Lancet Public Health. 2020 May;5(5):e259. doi: 10.1016/S2468-2667(20)30088-8. Epub 2020 Apr 8. No abstract available.

  PMID: 32277874 BACKGROUND

• Agarwal K, Luk JW, Stangl BL, Schwandt ML, Momenan R, Goldman D, Diazgranados N, Kareken DA, Leggio L, Ramchandani VA, Joseph PV. Parosmia Is Positively Associated With Problematic Drinking, as Is Phantosmia With Depressive Symptoms. J Addict Med. 2024 Sep-Oct 01;18(5):567-573. doi: 10.1097/ADM.0000000000001332. Epub 2024 May 22.

  PMID: 38776446 DERIVED

• Luk JW, Stangl BL, Gunawan T, Schwandt ML, Morris JK, Axelowitz JC, Chawla S, Lee BA, Carraco M, Walsh S, McDuffie C, Agarwal K, Joseph PV, Momenan R, Goldman D, Diazgranados N, Ramchandani VA. Changes in Alcohol-Related Behaviors and Quality of Life During the COVID-19 Pandemic: Impact of Alcohol Use Disorder Diagnosis and Treatment History. J Clin Psychiatry. 2022 Nov 7;84(1):22br14462. doi: 10.4088/JCP.22br14462. No abstract available.

  PMID: 36350598 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Alcohol Drinking; Alcohol-Related Disorders; Stress, Psychological; Coronavirus Infections; Alcoholism; Social Isolation

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Social Behavior

Study Officials

• Vijay A Ramchandani, Ph.D.

  National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vijay A Ramchandani, Ph.D.

CONTACT

(301) 402-8527; vijayr@mail.nih.gov

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 18, 2020
• Study Start: June 3, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04-24

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)