SARS-CoV-2 InfectionNCT05069090
Effect of COVID-19 Lockdown on Alcohol and Tobacco Use in Two Chilean Universities
An observational study of SARS-CoV-2 Infection and COVID-19, run by Universidad de La Frontera at 2 sites in Chile.
Trial summary
This is a longitudinal study of participants from two university communities in Chile. The primary objective is to examine the effect of a regional lockdown on alcohol and tobacco use, using a difference-in-difference analysis to obtain causal estimates of these COVID-19 policies. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Infection, COVID-19
- What is being tested?
- Lockdown and other social distancing measures
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,038 participants
- Where
- 2 sitesChile
- Study dates
- 3 Jun 2020to 30 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population are students, academics and administrative personnel of two universities in Chile
Who may be able to join
- People with study rights either at the undergraduate and postgraduate levels by July 27, 2020 at the Universidad de la Frontera or Universidad Católica del Norte; OR
- Workers with a full-time or part-time contract with either University, including academics, administrative and assistant personnel; AND
- Having an email registered in the Human Resource Office of each university
Who cannot join
- People without valid study rights at either university
- People without a working contract with the university
- Not having an email registered at the Human Resource Office
Trial locations and contacts
2 sites in 1 country.
Chile2 sites
Universidad Católica del Norte
Coquimbo
Universidad de la Frontera
Temuco, Araucania
About this study
Official title: Effect of COVID-19 Lockdown on Alcohol and Tobacco Use in Two Chilean Universities: a Difference-in-difference Analysis
This is a longitudinal study of participants from two university communities in Chile. The primary objective is to examine the effect of a regional lockdown on alcohol and tobacco use, using a difference-in-difference analysis to obtain causal estimates of these COVID-19 policies.
Read the detailed description
The COVID-19 pandemic is spreading worldwide. Countries have adopted public health and social measures that, together with a direct effect of the pandemic, can affect alcohol and tobacco use. The most stringent measures are lockdowns and curfews that include statutory restrictions on people's mobility. Research to date has shown mixed effects of the COVID-19 pandemic and lockdowns on alcohol and tobacco use. Importantly, previous studies have not been able to differentiate the effects of the pandemic itself with those from lockdown and curfew policies. They have also been restricted to countries in Europe, the United States, Australia and New Zealand.
The study will advance prior knowledge by providing evidence from a country in Latin America, one of the worst-hit regions worldwide. Latin America accounts for 8.4% of the global population, but 20.3% of the total SARS-COV2 cases and 30.2% of the COVID-19 deaths to date. In addition, the study will exploit the variation in lockdown policies in two regions in Chile to disentangle the effects of the COVID-19 pandemic with those from a lockdown.
The aim of the study is to examine the effect of a regional lockdown on alcohol use in two university populations in the Araucanía and Coquimbo regions in Chile. The investigators will use a difference-in-difference analysis to obtain causal estimates of these COVID-19 policies.
- Conditions
- SARS-CoV-2 Infection, COVID-19
- Being tested
- Lockdown and other social distancing measures
- Keywords
- Alcohol Drinking, Tobacco use, SARS-CoV-2, COVID-19, Epidemiology, Cohort Studies
- Medical subject headings
- COVID-19, Alcohol Drinking, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lockdown and other social distancing measuresBehavioural
During the study period, the Chilean Ministry of Health established a five-step process for social distancing measures. These ranged from full lockdown (step 1) to almost no restrictions (step 5). Even under full lockdown, citizens were able to obtain permits for essential activities. Citizens had a maximum of two permits per week and were obtained in a virtual station of the Chilean Police Force (Carabineros de Chile).
| Study group | Role | What they receive |
|---|---|---|
| Students and academics Universidad La Frontera | The intervention consists of social distancing measures to curb the viral transmission of SARS-CoV-2. The Araucanía region was subject to lockdown in a different moment than the Coquimbo region, creating exogenous variation. Receives: Behavioral: Lockdown and other social distancing measures | |
| Students and academics Universidad Católica del Norte | The intervention consists of social distancing measures to curb the viral transmission of SARS-CoV-2. The Coquimbo region was subject to lockdown in a different moment than the Araucanía region, creating exogenous variation. Receives: Behavioral: Lockdown and other social distancing measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly grams of alcohol use
Consumption of alcohol during the past week measured in grams of pure alcohol
Measured: Last week
Frequency of heavy episodic drinking in the past month
Frequency of consumption of five or more drinks on a single occasion during the past 30 days [response range 0 to 10 and more times]
Measured: Last 30 days
Quantity of cigarettes per day
Average daily consumption of cigarettes during the last week
Measured: Last week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start3 Jun 2020
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,038 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de La Frontera
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Católica del Norte
- Responsible party
- Principal investigator, Francisca Roman, Universidad de La Frontera
- Investigators
- Francisca Román, PhD, Principal investigator, Universidad de La Frontera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069090
- Sponsor's protocol ID
- ANID - COVID0282
- Status last verified
- Oct 2021
- First submitted
- 5 Oct 2021
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deanonymized data is available upon contact with the Principal Investigator
Publications
Jackson SE, Garnett C, Shahab L, Oldham M, Brown J. Association of the COVID-19 lockdown with smoking, drinking and attempts to quit in England: an analysis of 2019-20 data. Addiction. 2021 May;116(5):1233-1244. doi: 10.1111/add.15295. Epub 2020 Nov 26.
PubMed 33089562Winkler P, Formanek T, Mlada K, Kagstrom A, Mohrova Z, Mohr P, Csemy L. Increase in prevalence of current mental disorders in the context of COVID-19: analysis of repeated nationwide cross-sectional surveys. Epidemiol Psychiatr Sci. 2020 Sep 29;29:e173. doi: 10.1017/S2045796020000888.
PubMed 32988427Daly M, Robinson E. High-Risk Drinking in Midlife Before Versus During the COVID-19 Crisis: Longitudinal Evidence From the United Kingdom. Am J Prev Med. 2021 Feb;60(2):294-297. doi: 10.1016/j.amepre.2020.09.004. Epub 2020 Nov 21.
PubMed 33234355Niedzwiedz CL, Green MJ, Benzeval M, Campbell D, Craig P, Demou E, Leyland A, Pearce A, Thomson R, Whitley E, Katikireddi SV. Mental health and health behaviours before and during the initial phase of the COVID-19 lockdown: longitudinal analyses of the UK Household Longitudinal Study. J Epidemiol Community Health. 2021 Mar;75(3):224-231. doi: 10.1136/jech-2020-215060. Epub 2020 Sep 25.
PubMed 32978210Rossow I, Bye EK, Moan IS, Kilian C, Bramness JG. Changes in Alcohol Consumption during the COVID-19 Pandemic-Small Change in Total Consumption, but Increase in Proportion of Heavy Drinkers. Int J Environ Res Public Health. 2021 Apr 16;18(8):4231. doi: 10.3390/ijerph18084231.
PubMed 33923567Vanderbruggen N, Matthys F, Van Laere S, Zeeuws D, Santermans L, Van den Ameele S, Crunelle CL. Self-Reported Alcohol, Tobacco, and Cannabis Use during COVID-19 Lockdown Measures: Results from a Web-Based Survey. Eur Addict Res. 2020;26(6):309-315. doi: 10.1159/000510822. Epub 2020 Sep 22.
PubMed 32961535Nordeck CD, Riehm KE, Smail EJ, Holingue C, Kane JC, Johnson RM, Veldhuis CB, Kalb LG, Stuart EA, Kreuter F, Thrul J. Changes in drinking days among United States adults during the COVID-19 pandemic. Addiction. 2022 Feb;117(2):331-340. doi: 10.1111/add.15622. Epub 2021 Jul 12.
PubMed 34159674Glowacz F, Schmits E. Psychological distress during the COVID-19 lockdown: The young adults most at risk. Psychiatry Res. 2020 Nov;293:113486. doi: 10.1016/j.psychres.2020.113486. Epub 2020 Sep 25.
PubMed 33007682Callinan S, Smit K, Mojica-Perez Y, D'Aquino S, Moore D, Kuntsche E. Shifts in alcohol consumption during the COVID-19 pandemic: early indications from Australia. Addiction. 2021 Jun;116(6):1381-1388. doi: 10.1111/add.15275. Epub 2020 Oct 18.
PubMed 33006789Clare PJ, Aiken A, Yuen WS, Upton E, Kypri K, Degenhardt L, Bruno R, McCambridge J, McBride N, Hutchinson D, Slade T, Mattick R, Peacock A. Alcohol use among young Australian adults in May-June 2020 during the COVID-19 pandemic: a prospective cohort study. Addiction. 2021 Dec;116(12):3398-3407. doi: 10.1111/add.15599. Epub 2021 Jun 24.
PubMed 34105838Bartlett L, Brady JJR, Farrow M, Kim S, Bindoff A, Fair H, Vickers JC, Sinclair D. Change in modifiable dementia risk factors during COVID-19 lockdown: The experience of over 50s in Tasmania, Australia. Alzheimers Dement (N Y). 2021 May 13;7(1):e12169. doi: 10.1002/trc2.12169. eCollection 2021.
PubMed 34027023Bar-Zeev Y, Shauly M, Lee H, Neumark Y. Changes in Smoking Behaviour and Home-Smoking Rules during the Initial COVID-19 Lockdown Period in Israel. Int J Environ Res Public Health. 2021 Feb 17;18(4):1931. doi: 10.3390/ijerph18041931.
PubMed 33671203Bonadio WA, Carron AC, Nelson DB. Serum theophylline concentration in 82 consecutive asthmatic children receiving preadmission theophylline preparation. Pediatr Emerg Care. 1988 Jun;4(2):165. No abstract available.
PubMed 3380750Guignard R, Andler R, Quatremere G, Pasquereau A, du Roscoat E, Arwidson P, Berlin I, Nguyen-Thanh V. Changes in smoking and alcohol consumption during COVID-19-related lockdown: a cross-sectional study in France. Eur J Public Health. 2021 Oct 26;31(5):1076-1083. doi: 10.1093/eurpub/ckab054.
PubMed 33826721Pena S, Palet D, Salazar-Fernandez C, Roman Mella F. Effect of Regional COVID-19 Lockdowns on Alcohol Use and Smoking in Two Chilean University Communities: A Difference-In-Difference Analysis. Drug Alcohol Rev. 2026 Sep;45(6):e70229. doi: 10.1111/dar.70229.
PubMed 42580821
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of COVID-19 Lockdown on Alcohol and Tobacco Use in Two Chilean Universities: a Difference-in-difference Analysis
- ClinicalTrials.gov ID
- NCT05069090
- Acronym / sponsor ID
- ANID - COVID0282
- Conditions
- SARS-CoV-2 Infection, COVID-19
- Keywords
- Alcohol Drinking, Tobacco use, SARS-CoV-2, COVID-19, Epidemiology, Cohort Studies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,038 participants (actual)
- Lead sponsor
- Universidad de La FronteraUniversity, hospital or other
- Collaborators
- Universidad Católica del Norte
- Study start
- 3 Jun 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 6 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a longitudinal study of participants from two university communities in Chile. The primary objective is to examine the effect of a regional lockdown on alcohol and tobacco use, using a difference-in-difference analysis to obtain causal estimates of these COVID-19 policies.
Detailed description
The COVID-19 pandemic is spreading worldwide. Countries have adopted public health and social measures that, together with a direct effect of the pandemic, can affect alcohol and tobacco use. The most stringent measures are lockdowns and curfews that include statutory restrictions on people's mobility. Research to date has shown mixed effects of the COVID-19 pandemic and lockdowns on alcohol and tobacco use. Importantly, previous studies have not been able to differentiate the effects of the pandemic itself with those from lockdown and curfew policies. They have also been restricted to countries in Europe, the United States, Australia and New Zealand.
The study will advance prior knowledge by providing evidence from a country in Latin America, one of the worst-hit regions worldwide. Latin America accounts for 8.4% of the global population, but 20.3% of the total SARS-COV2 cases and 30.2% of the COVID-19 deaths to date. In addition, the study will exploit the variation in lockdown policies in two regions in Chile to disentangle the effects of the COVID-19 pandemic with those from a lockdown.
The aim of the study is to examine the effect of a regional lockdown on alcohol use in two university populations in the Araucanía and Coquimbo regions in Chile. The investigators will use a difference-in-difference analysis to obtain causal estimates of these COVID-19 policies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Students and academics Universidad La Frontera | – | Behavioral: Lockdown and other social distancing measuresThe intervention consists of social distancing measures to curb the viral transmission of SARS-CoV-2. The Araucanía region was subject to lockdown in a different moment than the Coquimbo region, creating exogenous variation. |
| Students and academics Universidad Católica del Norte | – | Behavioral: Lockdown and other social distancing measuresThe intervention consists of social distancing measures to curb the viral transmission of SARS-CoV-2. The Coquimbo region was subject to lockdown in a different moment than the Araucanía region, creating exogenous variation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population are students, academics and administrative personnel of two universities in Chile
Key inclusion criteria (3 listed)
- People with study rights either at the undergraduate and postgraduate levels by July 27, 2020 at the Universidad de la Frontera or Universidad Católica del Norte; OR
- Workers with a full-time or part-time contract with either University, including academics, administrative and assistant personnel; AND
- Having an email registered in the Human Resource Office of each university
Key exclusion criteria (3 listed)
- People without valid study rights at either university
- People without a working contract with the university
- Not having an email registered at the Human Resource Office
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lockdown and other social distancing measuresDuring the study period, the Chilean Ministry of Health established a five-step process for social distancing measures. These ranged from full lockdown (step 1) to almost no restrictions (step 5). Even under full lockdown, citizens were able to obtain permits for essential activities. Citizens had a maximum of two permits per week and were obtained in a virtual station of the Chilean Police Force (Carabineros de Chile). | Behavioural | Students and academics Universidad Católica del Norte, Students and academics Universidad La Frontera |
Primary outcome
Weekly grams of alcohol use
Time frame: Last week
Consumption of alcohol during the past week measured in grams of pure alcohol
Frequency of heavy episodic drinking in the past month
Time frame: Last 30 days
Frequency of consumption of five or more drinks on a single occasion during the past 30 days [response range 0 to 10 and more times]
Quantity of cigarettes per day
Time frame: Last week
Average daily consumption of cigarettes during the last week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Background: PubMed 33089562Jackson SE, Garnett C, Shahab L, Oldham M, Brown J. Association of the COVID-19 lockdown with smoking, drinking and attempts to quit in England: an analysis of 2019-20 data. Addiction. 2021 May;116(5):1233-1244. doi: 10.1111/add.15295. Epub 2020 Nov 26.
- Background: PubMed 32988427Winkler P, Formanek T, Mlada K, Kagstrom A, Mohrova Z, Mohr P, Csemy L. Increase in prevalence of current mental disorders in the context of COVID-19: analysis of repeated nationwide cross-sectional surveys. Epidemiol Psychiatr Sci. 2020 Sep 29;29:e173. doi: 10.1017/S2045796020000888.
- Background: PubMed 33234355Daly M, Robinson E. High-Risk Drinking in Midlife Before Versus During the COVID-19 Crisis: Longitudinal Evidence From the United Kingdom. Am J Prev Med. 2021 Feb;60(2):294-297. doi: 10.1016/j.amepre.2020.09.004. Epub 2020 Nov 21.
- Background: PubMed 32978210Niedzwiedz CL, Green MJ, Benzeval M, Campbell D, Craig P, Demou E, Leyland A, Pearce A, Thomson R, Whitley E, Katikireddi SV. Mental health and health behaviours before and during the initial phase of the COVID-19 lockdown: longitudinal analyses of the UK Household Longitudinal Study. J Epidemiol Community Health. 2021 Mar;75(3):224-231. doi: 10.1136/jech-2020-215060. Epub 2020 Sep 25.
- Background: PubMed 33923567Rossow I, Bye EK, Moan IS, Kilian C, Bramness JG. Changes in Alcohol Consumption during the COVID-19 Pandemic-Small Change in Total Consumption, but Increase in Proportion of Heavy Drinkers. Int J Environ Res Public Health. 2021 Apr 16;18(8):4231. doi: 10.3390/ijerph18084231.
- Background: PubMed 32961535Vanderbruggen N, Matthys F, Van Laere S, Zeeuws D, Santermans L, Van den Ameele S, Crunelle CL. Self-Reported Alcohol, Tobacco, and Cannabis Use during COVID-19 Lockdown Measures: Results from a Web-Based Survey. Eur Addict Res. 2020;26(6):309-315. doi: 10.1159/000510822. Epub 2020 Sep 22.
- Background: PubMed 34159674Nordeck CD, Riehm KE, Smail EJ, Holingue C, Kane JC, Johnson RM, Veldhuis CB, Kalb LG, Stuart EA, Kreuter F, Thrul J. Changes in drinking days among United States adults during the COVID-19 pandemic. Addiction. 2022 Feb;117(2):331-340. doi: 10.1111/add.15622. Epub 2021 Jul 12.
- Background: PubMed 33007682Glowacz F, Schmits E. Psychological distress during the COVID-19 lockdown: The young adults most at risk. Psychiatry Res. 2020 Nov;293:113486. doi: 10.1016/j.psychres.2020.113486. Epub 2020 Sep 25.
- Background: PubMed 33006789Callinan S, Smit K, Mojica-Perez Y, D'Aquino S, Moore D, Kuntsche E. Shifts in alcohol consumption during the COVID-19 pandemic: early indications from Australia. Addiction. 2021 Jun;116(6):1381-1388. doi: 10.1111/add.15275. Epub 2020 Oct 18.
- Background: PubMed 34105838Clare PJ, Aiken A, Yuen WS, Upton E, Kypri K, Degenhardt L, Bruno R, McCambridge J, McBride N, Hutchinson D, Slade T, Mattick R, Peacock A. Alcohol use among young Australian adults in May-June 2020 during the COVID-19 pandemic: a prospective cohort study. Addiction. 2021 Dec;116(12):3398-3407. doi: 10.1111/add.15599. Epub 2021 Jun 24.
- Background: PubMed 34027023Bartlett L, Brady JJR, Farrow M, Kim S, Bindoff A, Fair H, Vickers JC, Sinclair D. Change in modifiable dementia risk factors during COVID-19 lockdown: The experience of over 50s in Tasmania, Australia. Alzheimers Dement (N Y). 2021 May 13;7(1):e12169. doi: 10.1002/trc2.12169. eCollection 2021.
- Background: PubMed 33671203Bar-Zeev Y, Shauly M, Lee H, Neumark Y. Changes in Smoking Behaviour and Home-Smoking Rules during the Initial COVID-19 Lockdown Period in Israel. Int J Environ Res Public Health. 2021 Feb 17;18(4):1931. doi: 10.3390/ijerph18041931.
- Individual participant dataSharing planned: Yes. Deanonymized data is available upon contact with the Principal Investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisca Román, PhD principal investigator
Universidad de La Frontera
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2 Infection and COVID-19, run by Universidad de La Frontera at 2 sites in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weekly grams of alcohol use (time frame: Last week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05069090, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.