Image

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

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

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

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.

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

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.

Eligibility

  • 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.

Study details
    Alcohol Drinking
    Alcohol-Related Disorders
    Pandemic
    Psychological Stress

NCT04391816

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

29 May 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.