NCT04391816 COVID-19 Pandemic Impact on Alcohol (PIA) - A Natural History Study
| NCT ID | NCT04391816 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
| Condition | Alcohol Drinking |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2020-06-03 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,500 participants in total. It began in 2020-06-03 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
* 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.
Contact & Investigator
Vijay A Ramchandani, Ph.D.
PRINCIPAL INVESTIGATOR
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Frequently Asked Questions
Who can join the NCT04391816 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Alcohol Drinking. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04391816 currently recruiting?
Yes, NCT04391816 is actively recruiting participants. Contact the research team at vijayr@mail.nih.gov for enrollment information.
Where is the NCT04391816 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT04391816 clinical trial?
NCT04391816 is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The principal investigator is Vijay A Ramchandani, Ph.D. at National Institute on Alcohol Abuse and Alcoholism (NIAAA). The trial plans to enroll 1,500 participants.