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| ID | Type | Description | Link |
|---|---|---|---|
| 20-AA-0115 |
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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:
Because the course of the pandemic may change, the frequency of the surveys may change.
Participation lasts 2 years.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Participants | Participants that were previously enrolled in the NIAAA Screening Protocol. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Life Events Questionnaire (LEQ) Score | Life Events Questionnaire (LEQ): This questionnaire assesses positive and negative life events and their impact on participants | 24 monhts |
| UCLA Loneliness Scale (UCLA-LS) Score |
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In order to be eligible to participate in this study, an individual must meet all of the following criteria:
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.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vijay A Ramchandani, Ph.D. | Contact | (301) 402-8527 | vijayr@mail.nih.gov |
| Name | Affiliation | Role |
|---|---|---|
| Vijay A Ramchandani, Ph.D. | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIAAA Section on Human Psychopharmacology | Recruiting | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20977977 | Background | 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. | |
| 32242888 | Background | 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. |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D019973 | Alcohol-Related Disorders |
| D013315 | Stress, Psychological |
| D018352 | Coronavirus Infections |
| D000437 | Alcoholism |
| D012934 | Social Isolation |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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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 |
| Perceived Stress Scale (PSS) Score | Perceived stress scale (PSS): This is a 10-item scale to measure perception of stress | 24 months |
| 32277874 | Background | 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. |
| 38776446 | Derived | Agarwal K, Luk JW, Stangl BL, Schwandt ML, Momenan R, Goldman D, Diazgranados N, Kareken DA, Leggio L, Ramchandani VA, Joseph PV. Parosmia Is Positively Associated With Problematic Drinking, as Is Phantosmia With Depressive Symptoms. J Addict Med. 2024 Sep-Oct 01;18(5):567-573. doi: 10.1097/ADM.0000000000001332. Epub 2024 May 22. |
| 36350598 | Derived | Luk JW, Stangl BL, Gunawan T, Schwandt ML, Morris JK, Axelowitz JC, Chawla S, Lee BA, Carraco M, Walsh S, McDuffie C, Agarwal K, Joseph PV, Momenan R, Goldman D, Diazgranados N, Ramchandani VA. Changes in Alcohol-Related Behaviors and Quality of Life During the COVID-19 Pandemic: Impact of Alcohol Use Disorder Diagnosis and Treatment History. J Clin Psychiatry. 2022 Nov 7;84(1):22br14462. doi: 10.4088/JCP.22br14462. No abstract available. |
| D001523 |
| Mental Disorders |
| D001526 | Behavioral Symptoms |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D012919 | Social Behavior |