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

 Study Population:

 The target sample size for this study will consist of 700 participants including,
 non-drinkers, light drinkers, non-treatment-seeking heavy drinkers, and treatment-seeking
 individuals with alcohol use disorder who have been screened under the NIAAA Screening,
 Assessment and Management (SAM) Protocol (14-AA-0181). As this is a natural history study,
 recruitment will be open to all participants from the NIAAA screening protocol. We will not
 select participants based on sex, gender, race, ethnicity, or age.

 Description of Sites/Facilities Enrolling Participants:

 NIAAA Intramural Clinical Research Program located in the NIH Clinical Center, Bethesda, MD.
 Study will be conducted via telephone and online survey, and participants will not have
 in-person study visits.

 Study Duration: 60 months

 Participant Duration: 24 months
-  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.