Recruiting

Observational Study

Sponsor:

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Code:

NCT04391816

Conditions

Alcohol Drinking

Alcohol-Related Disorders

Pandemic

Psychological Stress

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Alcohol Drinking

Alcohol-Related Disorders

Pandemic

Psychological Stress

Study ID

NCT04391816

Start date

Jun 3, 2020

Status verified date

Jun 17, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

  • 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.

Study Design

Enrollment

1500 participants

Anticipated

Interventions and Outcome Measures

Arms

Study Participants

Participants that were previously enrolled in the NIAAA Screening Protocol.

Primary outcome measure

  • AUDIT Score [ Time Frame: 24 months ]
  • ADS Score [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Vijay A Ramchandani, Ph.D.

(301) 402-8527vijayr@mail.nih.gov

Locations

NIAAA Section on Human Psychopharmacology

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

Vijay Ramchandani, Ph.D.

301-402-8527vijayr@mail.nih.gov

More Information

Sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Last update posted

Jun 24, 2026

Last verified

Jun 17, 2026

Keywords

  • Coronavirus
  • Alcohol Use Disorder
  • SARS-CoV2
  • Stress
  • Social Isolation
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute on Alcohol Abuse and Alcoholism (NIAAA) on 2026-06-24.