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

Alcohol Drinking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04391816
• Other study ID #: 200115
• Secondary ID: 20-AA-0115
• Status: Recruiting
• Start date: June 3, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: May 15, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Vijay A Ramchandani, Ph.D.
• Phone: (301) 402-8527
• Email: vijayr[@]mail.nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol-Related Disorders
• COVID-19
• Pandemic
• Psychological Stress
• Stress, Psychological

Locations

Country	Name	City	State
United States	NIAAA Section on Human Psychopharmacology	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Cerda M, Tracy M, Galea S. A prospective population based study of changes in alcohol use and binge drinking after a mass traumatic event. Drug Alcohol Depend. 2011 May 1;115(1-2):1-8. doi: 10.1016/j.drugalcdep.2010.09.011. Epub 2010 Oct 24. — View Citation

Clay JM, Parker MO. Alcohol use and misuse during the COVID-19 pandemic: a potential public health crisis? Lancet Public Health. 2020 May;5(5):e259. doi: 10.1016/S2468-2667(20)30088-8. Epub 2020 Apr 8. No abstract available. — View Citation

Druss BG. Addressing the COVID-19 Pandemic in Populations With Serious Mental Illness. JAMA Psychiatry. 2020 Sep 1;77(9):891-892. doi: 10.1001/jamapsychiatry.2020.0894. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUDIT Score	Alcohol Use Disorder Identification Test (AUDIT): This is a 10-item questionnaire designed to screen for AUD. The first 3 questions constitute the AUDIT-C and provides a measure of alcohol consumption. The total score provides a continuous quantification of AUD severity.	24 months
Primary	ADS Score	Alcohol Dependence Scale (ADS): This 25-item scale will be used to measure severity of alcohol dependence. This scale covers alcohol withdrawal symptoms, impaired control over drinking, awareness of a compulsion to drink, increased tolerance to alcohol, and salience of drink-seeking behavior.	24 months
Secondary	Life Events Questionnaire (LEQ) Score	Life Events Questionnaire (LEQ): This questionnaire assesses positive and negative life events and their impact on participants	24 monhts
Secondary	UCLA Loneliness Scale (UCLA-LS) Score	UCLA Loneliness Scale (UCLA-LS): This is a 20-item scale designed to measure a person s subjective feeling of loneliness and social isolation in the last month	24 months
Secondary	Perceived Stress Scale (PSS) Score	Perceived stress scale (PSS): This is a 10-item scale to measure perception of stress	24 months

External Links

•   NIH Clinical Center Detailed Web Page