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

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ClinicalTrials.gov Identifier: NCT04391816
Recruitment Status : Recruiting
First Posted : May 18, 2020
Last Update Posted : November 26, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Alcohol Abuse and Alcoholism (NIAAA) )

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.


Condition or disease
Alcohol Drinking Alcohol-Related Disorders Pandemic Psychological Stress

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:

  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

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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: COVID-19 Pandemic Impact on Alcohol (PIA) - A Natural History Study
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2024

Group/Cohort
Study Participants
Participants that were previously enrolled in the NIAAA Screening Protocol.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. UCLA Loneliness Scale (UCLALS) Score [ Time Frame: 24 months ]
    UCLA Loneliness Scale (UCLALS): This is a 20-item scale designed to measure a person s subjective feeling of loneliness and social isolation in the last month

  3. Perceived Stress Scale (PSS) Score [ Time Frame: 24 months ]
    Perceived stress scale (PSS): This is a 10-item scale to measure perception of stress



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The target population for this study includes healthy adults across the spectrum of alcohol use who have been screened under the NIAAA screening protocol (14-AA-0181). This sample includes non-drinkers, light drinkers, non-treatment-seeking heavy drinkers, and treatment-seeking individuals with alcohol use disorder.
Criteria
  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04391816


Contacts
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Contact: Vijay A Ramchandani, Ph.D. (301) 402-8527 vijayr@mail.nih.gov

Locations
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United States, Maryland
NIAAA Section on Human Psychopharmacology Recruiting
Bethesda, Maryland, United States, 20892
Contact: Vijay Ramchandani, Ph.D.    301-402-8527    vijayr@mail.nih.gov   
Sponsors and Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Vijay A Ramchandani, Ph.D. National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Additional Information:
Publications:
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Responsible Party: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier: NCT04391816    
Other Study ID Numbers: 200115
20-AA-0115
First Posted: May 18, 2020    Key Record Dates
Last Update Posted: November 26, 2020
Last Verified: June 15, 2020
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute on Alcohol Abuse and Alcoholism (NIAAA) ):
Coronavirus
Alcohol Use Disorder
SARS-CoV-2
Stress
Social Isolation
Additional relevant MeSH terms:
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Alcohol-Related Disorders
Alcohol Drinking
Stress, Psychological
Drinking Behavior
Behavioral Symptoms
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders