- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04391816
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 Overview
Status
Detailed 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:
- 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.
- 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.
- (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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Vijay A Ramchandani, Ph.D.
- Phone Number: (301) 402-8527
- Email: vijayr@mail.nih.gov
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- Recruiting
- NIAAA Section on Human Psychopharmacology
-
Contact:
- Vijay Ramchandani, Ph.D.
- Phone Number: 301-402-8527
- Email: vijayr@mail.nih.gov
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
INCLUSION CRITERIA:
- Participants who have enrolled in the NIAAA Screening Protocol (14-AA-0181) and completed screening and phenotyping assessments.
- 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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Study Participants
Participants that were previously enrolled in the NIAAA Screening Protocol.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUDIT Score
Time Frame: 24 months
|
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
|
ADS Score
Time Frame: 24 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Life Events Questionnaire (LEQ) Score
Time Frame: 24 monhts
|
Life Events Questionnaire (LEQ): This questionnaire assesses positive and negative life events and their impact on participants
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24 monhts
|
UCLA Loneliness Scale (UCLA-LS) Score
Time Frame: 24 months
|
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
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24 months
|
Perceived Stress Scale (PSS) Score
Time Frame: 24 months
|
Perceived stress scale (PSS): This is a 10-item scale to measure perception of stress
|
24 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Vijay A Ramchandani, Ph.D., National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Chemically-Induced Disorders
- Drinking Behavior
- Substance-Related Disorders
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Alcohol Drinking
- COVID-19
- Stress, Psychological
- Alcohol-Related Disorders
Other Study ID Numbers
- 200115
- 20-AA-0115
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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