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

Detailed Description

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:

1. To evaluate the impact of the COVID-19 pandemic on alcohol consumption and consequences
in individuals across the spectrum of alcohol use and those with AUD.

2. To evaluate the time-course of changes in measures of negative life events, social
isolation and stress, and their effect on alcohol consumption and consequences over a
24-month period during and following the COVID-19 pandemic.

3. (Exploratory aim) To examine the role of anxiety, depression, craving, binge drinking,
impaired control in the relationships examined above.

Endpoints:

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. 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.

Recruiting
Alcohol Drinking
Alcohol-Related Disorders
Pandemic
Psychological Stress
Eligibility Criteria

- INCLUSION CRITERIA:

1. Participants who have enrolled in the NIAAA Screening Protocol (14-AA-0181) and
completed screening and phenotyping assessments.

2. Willing and able to complete frequent (weekly to monthly) surveys either online
or by phone.

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 100 Years
Countries
United States
Locations

NIAAA Section on Human Psychopharmacology
Bethesda, Maryland, United States

Investigator: Vijay Ramchandani, Ph.D.
Contact: 301-402-8527
vijayr@mail.nih.gov

Contacts

Vijay A Ramchandani, Ph.D.
(301) 402-8527
vijayr@mail.nih.gov

Vijay A Ramchandani, Ph.D., Principal Investigator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NCT Number
Keywords
Coronavirus
Alcohol use Disorder
SARS-CoV2
Stress
Social Isolation
Natural History
MeSH Terms
COVID-19
Alcohol-Related Disorders
Alcohol Drinking
Stress, Psychological