An observational study in Alcohol Drinking, Alcohol-Related Disorders and Pandemic, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA). Recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA) · Observational
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:
Because the course of the pandemic may change, the frequency of the surveys may change.
Participation lasts 2 years.
Study Description:
The novel coronavirus (SARS-CoV-2) outbreak started in 2019 and has resulted in a world-wide pandemic infection designated COVID-19. This pandemic has become an unprecedented global threat to individuals, communities and health systems. While immediate attention has appropriately focused on prevention and treatment of SARS CoV-2 infection, the widespread societal mental health consequences of the pandemic cannot be ignored. Given the catastrophic impact of the COVID-19 pandemic, it is critical to prospectively and longitudinally assess the impact on alcohol use and problems, along with associated behaviors and outcomes. Thus, the goal of this study is to examine the impact of the COVID-19 pandemic on alcohol use and consequences in individuals across the spectrum of alcohol use and alcohol use disorder.
Objectives:
The specific aims of this study are:
Endpoints:
In Phase 1 of the study (conducted from June 2020-September 2023), participants will be invited to complete several surveys by phone and/or online over 2 years at intervals that range from weekly to bimonthly in the first year and every 6 months during the second year. Depending on the trajectory of the pandemic, the frequency of the surveys may be modified if necessary. In Phase 2 of the study (starting in October 2023), participants will complete surveys by phone and/or online over 3 years at 1 to 3-month intervals. The surveys will assess a range of outcomes related to alcohol consumption and consequences, along with measures of other substance use, stress, sleep, physical health and quality of life.
156 studies on the registry are indexed under Alcohol-Related Disorders; 23 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 309 across 16 observational studies indexed under Alcohol-Related Disorders.
Browse Alcohol-Related Disorders studies →National Institute on Alcohol Abuse and Alcoholism (NIAAA) is the lead sponsor of 102 studies on the registry; 14 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 9 (69%) have results posted.
Compared within Alcohol-Related Disorders, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Alcohol Drinking. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
EXCLUSION CRITERIA:
As this is a natural history protocol, there are no formal exclusionary criteria for this study. Participants who are determined by the interviewer to be uncooperative or unable to provide consent via telephone will not be enrolled into the study.
Participants that were previously enrolled in the NIAAA Screening Protocol.
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.
Time frame: 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.
Time frame: 24 months
Life Events Questionnaire (LEQ) Score
Life Events Questionnaire (LEQ): This questionnaire assesses positive and negative life events and their impact on participants
Time frame: 24 monhts
UCLA Loneliness Scale (UCLA-LS) Score
UCLA Loneliness Scale (UCLA-LS): This is a 20-item scale designed to measure a person s subjective feeling of loneliness and social isolation in the last month
Time frame: 24 months
Perceived Stress Scale (PSS) Score
Perceived stress scale (PSS): This is a 10-item scale to measure perception of stress
Time frame: 24 months
Plan to share: No
Started Jun 2020 (actual). Primary completion is estimated for Dec 2026, 78 months after the start.
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National Institute on Alcohol Abuse and Alcoholism (NIAAA) →