Background:The SARS-CoV-2 virus has caused a pandemic infection called COVID-19. It is a globalthreat to people, communities, and health systems. Researchers are concerned about themental health effects of the pandemic. They want to learn more about how it is affectingpeople 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 inindividuals across the spectrum of alcohol use and those with alcohol use disorder.Eligibility:Participants who have been screened under the NIAAA Screening, Assessment and ManagementProtocol (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 thepandemic started and the time since it started.Participants will get an ID code and a link to an online survey. They will complete theonline 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 8weeks, and then every 1-2 months for the rest of the year. For the second year, surveyswill 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.
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 2-3 year 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:
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.
- INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet all of the
following criteria:
1. Participants who have enrolled in the NIAAA Natural History 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.
NIAAA Section on Human Psychopharmacology
Bethesda, Maryland, United States
Investigator: Vijay Ramchandani, Ph.D.
Contact: 301-402-8527
vijayr@mail.nih.gov
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)