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

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, pain, 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

Details