Alcohol-Related DisordersNCT05865847
Socioeconomic Differences in Alcohol Harm in Finland in a Nationwide Cohort Study
An observational study of Alcohol-Related Disorders, run by Finnish Institute for Health and Welfare.
Trial summary
This is a nationwide cohort study of Finnish adults aged 25 and older, who are followed up for the incidence of an alcohol-attributable hospitalization or death. The primary objective is to examine the relative and absolute socioeconomic differences in cause-specific alcohol-attributable hospital admissions and deaths. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol-Related Disorders
- What is being tested?
- Not applicable, this is an observational study
- How many people
- 3,950,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 30 Sep 2023
- 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 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All permanent residents in Finland older than 25 years old and without an alcohol-attributable hospital admission during the past three years
Who may be able to join
- Permanent residents (defined by Statistics Finland as those Finnish and foreign nationals who have a legal domicile in Finland and intend to stay (or have stayed) for at least one year) alive in Finland by December 31, 2015
- Age 25 years or older by January 1, 2016
- Not having an alcohol-attributable hospitalization during the past three years ((January 2013-December 2015
Who cannot join
- Temporary residents, including foreign nationals living in Finland for less than a year, asylum seekers who have not been granted a legal domicile, temporary migrant workers and Finnish nationals living temporarily abroad by December 31, 2015
About this study
Official title: Unveiling the Alcohol Harm Paradox: Analysis of Socioeconomic Differences in Alcohol Harm in Finland in a Nationwide Cohort Study
This is a nationwide cohort study of Finnish adults aged 25 and older, who are followed up for the incidence of an alcohol-attributable hospitalization or death. The primary objective is to examine the relative and absolute socioeconomic differences in cause-specific alcohol-attributable hospital admissions and deaths.
Read the detailed description
Background
Alcohol consumption is a leading risk factor for death and disability, resulting in substantial societal costs and social and community harm. Alcohol-related harm has been consistently shown to be higher among people of lower socioeconomic status, despite the fact they often report similar or lower levels of alcohol use. This apparent contrast has been called the alcohol harm paradox.
Understanding what explains the alcohol harm paradox is crucial for the design and implementation of population health interventions to reduce socioeconomic differences in alcohol harm. Explanations for the paradox can be broadly categorised into three groups: (i) differential exposure to alcohol, drinking patterns and trajectories and to other behavioural risk factors and joint effects among them, (ii) differential vulnerability resulting from individual factors, such as biological characteristics, psychological traits or stress, cumulative disadvantage and broader community and societal upstream factors, and (iii) differential biases in the measurement of alcohol exposure.
A crucial weakness of existing empirical studies comes from the operationalization of alcohol harm. With few exceptions, a vast majority of studies has used a composite endpoint combining several causes of alcohol-attributable deaths or hospitalizations or even merging alcohol-attributable hospital admissions with deaths in a single outcome. While this strategy increases the statistical power to analyse rare events, composite endpoints are prone to misclassification bias by masking divergent underlying patterns and associations.
Cause-specific analyses might shed light on different mechanisms driving the socioeconomic differences in overall alcohol-attributable harm, as well as opening potential avenues for policy interventions to reduce them. The study will take advantage of a recently formed dataset covering the total Finnish population to explore associations between socioeconomic status and cause-specific alcohol-attributable events. An additional contribution to the literature will be reporting both relative and absolute inequalities in alcohol-attributable harm. Absolute differences have been rarely reported even though might be as relevant as relative differences because, from a pragmatic standpoint, they are more feasible to reduce.
The study will aim to (1) examine the relative and absolute socioeconomic differences in cause-specific alcohol-attributable hospital admissions and deaths; (2) describe the geographical differences in cause-specific alcohol-attributable hospital admissions and deaths; and (3) quantify the relative contribution of each specific alcohol-attributable cause to the overall alcohol-attributable harm.
- Conditions
- Alcohol-Related Disorders
- Being tested
- Not applicable, this is an observational study
- Medical subject headings
- Alcohol-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable, this is an observational studyOther
Not applicable, this is an observational study
| Study group | Role | What they receive |
|---|---|---|
| Lowest income groups | Deciles of equivalized net household income. The method compares the whole socioeconomic distribution. Receives: Other: Not applicable, this is an observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol intoxication - Hospitalization
Incidence of alcohol intoxication hospitalization (ICD-10 F10.0-1)
Measured: January 1, 2016 to February 28, 2020
Alcohol intoxication - Death
Death due to alcohol intoxication (ICD-10 F10.0-1)
Measured: January 1, 2016 to February 28, 2020
Alcohol dependence - Hospitalization
Incidence of hospitalization due to alcohol dependence (F10.2)
Measured: January 1, 2016 to February 28, 2020
Alcohol dependence - Death
Death due to alcohol dependence (F10.2)
Measured: January 1, 2016 to February 28, 2020
Psycho-organic syndrome caused by alcohol - Hospitalization
Incidence of hospitalization due to psycho-organic syndrome caused by alcohol (F10.3-9)
Measured: January 1, 2016 to February 28, 2020
Psycho-organic syndrome caused by alcohol - Death
Death due to psycho-organic syndrome caused by alcohol (F10.3-9)
Measured: January 1, 2016 to February 28, 2020
Alcoholic liver disease - Hospitalization
Incidence of hospitalization due to alcoholic liver disease(K70)
Measured: January 1, 2016 to February 28, 2020
Alcoholic liver disease - Death
Death due to alcoholic liver disease(K70)
Measured: January 1, 2016 to February 28, 2020
Pancreatic diseases caused by alcohol - Hospitalization
Incidence of hospitalization due to pancreatic diseases caused by alcohol (K85.2, K86.0)
Measured: January 1, 2016 to February 28, 2020
Pancreatic diseases caused by alcohol - Death
Death due to pancreatic diseases caused by alcohol (K85.2, K86.0)
Measured: January 1, 2016 to February 28, 2020
Gastritis caused by alcohol - Hospitalization
Incidence of hospitalization due to gastritis caused by alcohol (K29.2)
Measured: January 1, 2016 to February 28, 2020
Gastritis caused by alcohol - Death
Death due to gastritis caused by alcohol (K29.2)
Measured: January 1, 2016 to February 28, 2020
Alcoholic cardiomyopathy - Hospitalization
Incidence of hospitalization due to alcoholic cardiomyopathy (I42.6)
Measured: January 1, 2016 to February 28, 2020
Alcoholic cardiomyopathy - Death
Death due to alcoholic cardiomyopathy (I42.6)
Measured: January 1, 2016 to February 28, 2020
Nervous system disorders caused by alcohol - Hospitalization
Incidence of hospitalization due to degeneration of the nervous system due to alcohol, epileptic seizures related to alcohol, alcoholic polyneuropathy, alcoholic myopathy (G312, G4051, G621, G721)
Measured: January 1, 2016 to February 28, 2020
Nervous system disorders caused by alcohol - Death
Death due to degeneration of the nervous system due to alcohol, epileptic seizures related to alcohol, alcoholic polyneuropathy, alcoholic myopathy (G312, G4051, G621, G721)
Measured: January 1, 2016 to February 28, 2020
Alcohol poisoning - Hospitalization
Incidence of hospitalization due to alcohol poisoning (T51, X45)
Measured: January 1, 2016 to February 28, 2020
Alcohol poisoning - Death
Death due to alcohol poisoning (T51, X45)
Measured: January 1, 2016 to February 28, 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start1 Jan 2015
- Primary completion28 Feb 2020
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Alcohol-Related DisordersStudies 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
- 3,950,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Finnish Institute for Health and Welfare
- Sponsor type
- Other government
- Collaborators
- Social Insurance Institution, Finland
- Responsible party
- Sponsor
- Investigators
- Sebastián Peña, MD, PhD, Principal investigator, Finnish Institute for Health and WelfareSonja Lumme, PhD, Study chair, Finnish Institute for Health and WelfarePäivikki Koponen, PhD, Study chair, Finnish Institute for Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865847
- Sponsor's protocol ID
- KKO-Inv 4-Johto-VPT-Terveysind
- Status last verified
- May 2023
- First submitted
- 3 May 2023
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will share the harmonization protocol to define the variables and the statistical code. Individual participant data is available upon request at FinData, following national data protection procedures.
Publications
GBD 2016 Alcohol Collaborators. Alcohol use and burden for 195 countries and territories, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2018 Sep 22;392(10152):1015-1035. doi: 10.1016/S0140-6736(18)31310-2. Epub 2018 Aug 23.
PubMed 30146330Manthey J, Hassan SA, Carr S, Kilian C, Kuitunen-Paul S, Rehm J. What are the Economic Costs to Society Attributable to Alcohol Use? A Systematic Review and Modelling Study. Pharmacoeconomics. 2021 Jul;39(7):809-822. doi: 10.1007/s40273-021-01031-8. Epub 2021 May 10.
PubMed 33970445Room R, Ferris J, Laslett AM, Livingston M, Mugavin J, Wilkinson C. The drinker's effect on the social environment: a conceptual framework for studying alcohol's harm to others. Int J Environ Res Public Health. 2010 Apr;7(4):1855-71. doi: 10.3390/ijerph7041855. Epub 2010 Apr 21.
PubMed 20617064Probst C, Lange S, Kilian C, Saul C, Rehm J. The dose-response relationship between socioeconomic deprivation and alcohol-attributable mortality risk-a systematic review and meta-analysis. BMC Med. 2021 Nov 5;19(1):268. doi: 10.1186/s12916-021-02132-z.
PubMed 34736475Probst C, Kilian C, Sanchez S, Lange S, Rehm J. The role of alcohol use and drinking patterns in socioeconomic inequalities in mortality: a systematic review. Lancet Public Health. 2020 Jun;5(6):e324-e332. doi: 10.1016/S2468-2667(20)30052-9.
PubMed 32504585Syden L, Sidorchuk A, Makela P, Landberg J. The contribution of alcohol use and other behavioural, material and social factors to socio-economic differences in alcohol-related disorders in a Swedish cohort. Addiction. 2017 Nov;112(11):1920-1930. doi: 10.1111/add.13889. Epub 2017 Jul 17.
PubMed 28556302Makela P, Paljarvi T. Do consequences of a given pattern of drinking vary by socioeconomic status? A mortality and hospitalisation follow-up for alcohol-related causes of the Finnish Drinking Habits Surveys. J Epidemiol Community Health. 2008 Aug;62(8):728-33. doi: 10.1136/jech.2007.065672.
PubMed 18621959Pena S, Makela P, Laatikainen T, Harkanen T, Mannisto S, Heliovaara M, Koskinen S. Joint effects of alcohol use, smoking and body mass index as an explanation for the alcohol harm paradox: causal mediation analysis of eight cohort studies. Addiction. 2021 Aug;116(8):2220-2230. doi: 10.1111/add.15395. Epub 2021 Jan 28.
PubMed 33404149Katikireddi SV, Whitley E, Lewsey J, Gray L, Leyland AH. Socioeconomic status as an effect modifier of alcohol consumption and harm: analysis of linked cohort data. Lancet Public Health. 2017 May 10;2(6):e267-e276. doi: 10.1016/S2468-2667(17)30078-6. eCollection 2017 Jun.
PubMed 28626829Makela P. Alcohol-related mortality as a function of socio-economic status. Addiction. 1999 Jun;94(6):867-86. doi: 10.1046/j.1360-0443.1999.94686710.x.
PubMed 10665076Pena S, Makela P, Harkanen T, Heliovaara M, Gunnar T, Mannisto S, Laatikainen T, Vartiainen E, Koskinen S. Measurement error as an explanation for the alcohol harm paradox: analysis of eight cohort studies. Int J Epidemiol. 2021 Jan 23;49(6):1836-1846. doi: 10.1093/ije/dyaa113.
PubMed 32995840Sadler S, Angus C, Gavens L, Gillespie D, Holmes J, Hamilton J, Brennan A, Meier P. Understanding the alcohol harm paradox: an analysis of sex- and condition-specific hospital admissions by socio-economic group for alcohol-associated conditions in England. Addiction. 2017 May;112(5):808-817. doi: 10.1111/add.13726. Epub 2017 Feb 6.
PubMed 27981670Mackenbach JP, Kulhanova I, Bopp M, Borrell C, Deboosere P, Kovacs K, Looman CW, Leinsalu M, Makela P, Martikainen P, Menvielle G, Rodriguez-Sanz M, Rychtarikova J, de Gelder R. Inequalities in Alcohol-Related Mortality in 17 European Countries: A Retrospective Analysis of Mortality Registers. PLoS Med. 2015 Dec 1;12(12):e1001909. doi: 10.1371/journal.pmed.1001909. eCollection 2015 Dec.
PubMed 26625134Mackenbach JP. Should we aim to reduce relative or absolute inequalities in mortality? Eur J Public Health. 2015 Apr;25(2):185. doi: 10.1093/eurpub/cku217. No abstract available.
PubMed 25818489
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unveiling the Alcohol Harm Paradox: Analysis of Socioeconomic Differences in Alcohol Harm in Finland in a Nationwide Cohort Study
- ClinicalTrials.gov ID
- NCT05865847
- Acronym / sponsor ID
- KKO-Inv 4-Johto-VPT-Terveysind
- Conditions
- Alcohol-Related Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,950,000 participants (estimated)
- Lead sponsor
- Finnish Institute for Health and WelfareOther government
- Collaborators
- Social Insurance Institution, Finland
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 19 May 2023 (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 nationwide cohort study of Finnish adults aged 25 and older, who are followed up for the incidence of an alcohol-attributable hospitalization or death. The primary objective is to examine the relative and absolute socioeconomic differences in cause-specific alcohol-attributable hospital admissions and deaths.
Detailed description
Background
Alcohol consumption is a leading risk factor for death and disability, resulting in substantial societal costs and social and community harm. Alcohol-related harm has been consistently shown to be higher among people of lower socioeconomic status, despite the fact they often report similar or lower levels of alcohol use. This apparent contrast has been called the alcohol harm paradox.
Understanding what explains the alcohol harm paradox is crucial for the design and implementation of population health interventions to reduce socioeconomic differences in alcohol harm. Explanations for the paradox can be broadly categorised into three groups: (i) differential exposure to alcohol, drinking patterns and trajectories and to other behavioural risk factors and joint effects among them, (ii) differential vulnerability resulting from individual factors, such as biological characteristics, psychological traits or stress, cumulative disadvantage and broader community and societal upstream factors, and (iii) differential biases in the measurement of alcohol exposure.
A crucial weakness of existing empirical studies comes from the operationalization of alcohol harm. With few exceptions, a vast majority of studies has used a composite endpoint combining several causes of alcohol-attributable deaths or hospitalizations or even merging alcohol-attributable hospital admissions with deaths in a single outcome. While this strategy increases the statistical power to analyse rare events, composite endpoints are prone to misclassification bias by masking divergent underlying patterns and associations.
Cause-specific analyses might shed light on different mechanisms driving the socioeconomic differences in overall alcohol-attributable harm, as well as opening potential avenues for policy interventions to reduce them. The study will take advantage of a recently formed dataset covering the total Finnish population to explore associations between socioeconomic status and cause-specific alcohol-attributable events. An additional contribution to the literature will be reporting both relative and absolute inequalities in alcohol-attributable harm. Absolute differences have been rarely reported even though might be as relevant as relative differences because, from a pragmatic standpoint, they are more feasible to reduce.
The study will aim to (1) examine the relative and absolute socioeconomic differences in cause-specific alcohol-attributable hospital admissions and deaths; (2) describe the geographical differences in cause-specific alcohol-attributable hospital admissions and deaths; and (3) quantify the relative contribution of each specific alcohol-attributable cause to the overall alcohol-attributable harm.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lowest income groups | – | Other: Not applicable, this is an observational studyDeciles of equivalized net household income. The method compares the whole socioeconomic distribution. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All permanent residents in Finland older than 25 years old and without an alcohol-attributable hospital admission during the past three years
Key inclusion criteria (3 listed)
- Permanent residents (defined by Statistics Finland as those Finnish and foreign nationals who have a legal domicile in Finland and intend to stay (or have stayed) for at least one year) alive in Finland by December 31, 2015
- Age 25 years or older by January 1, 2016
- Not having an alcohol-attributable hospitalization during the past three years ((January 2013-December 2015
Key exclusion criteria (1 listed)
- Temporary residents, including foreign nationals living in Finland for less than a year, asylum seekers who have not been granted a legal domicile, temporary migrant workers and Finnish nationals living temporarily abroad by December 31, 2015
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 |
|---|---|---|
| Not applicable, this is an observational studyNot applicable, this is an observational study | Other | Lowest income groups |
Primary outcome
Alcohol intoxication - Hospitalization
Time frame: January 1, 2016 to February 28, 2020
Incidence of alcohol intoxication hospitalization (ICD-10 F10.0-1)
Alcohol intoxication - Death
Time frame: January 1, 2016 to February 28, 2020
Death due to alcohol intoxication (ICD-10 F10.0-1)
Alcohol dependence - Hospitalization
Time frame: January 1, 2016 to February 28, 2020
Incidence of hospitalization due to alcohol dependence (F10.2)
Alcohol dependence - Death
Time frame: January 1, 2016 to February 28, 2020
Death due to alcohol dependence (F10.2)
Psycho-organic syndrome caused by alcohol - Hospitalization
Time frame: January 1, 2016 to February 28, 2020
Incidence of hospitalization due to psycho-organic syndrome caused by alcohol (F10.3-9)
Psycho-organic syndrome caused by alcohol - Death
Time frame: January 1, 2016 to February 28, 2020
Death due to psycho-organic syndrome caused by alcohol (F10.3-9)
Alcoholic liver disease - Hospitalization
Time frame: January 1, 2016 to February 28, 2020
Incidence of hospitalization due to alcoholic liver disease(K70)
Alcoholic liver disease - Death
Time frame: January 1, 2016 to February 28, 2020
Death due to alcoholic liver disease(K70)
Pancreatic diseases caused by alcohol - Hospitalization
Time frame: January 1, 2016 to February 28, 2020
Incidence of hospitalization due to pancreatic diseases caused by alcohol (K85.2, K86.0)
Pancreatic diseases caused by alcohol - Death
Time frame: January 1, 2016 to February 28, 2020
Death due to pancreatic diseases caused by alcohol (K85.2, K86.0)
Gastritis caused by alcohol - Hospitalization
Time frame: January 1, 2016 to February 28, 2020
Incidence of hospitalization due to gastritis caused by alcohol (K29.2)
Gastritis caused by alcohol - Death
Time frame: January 1, 2016 to February 28, 2020
Death due to gastritis caused by alcohol (K29.2)
Alcoholic cardiomyopathy - Hospitalization
Time frame: January 1, 2016 to February 28, 2020
Incidence of hospitalization due to alcoholic cardiomyopathy (I42.6)
Alcoholic cardiomyopathy - Death
Time frame: January 1, 2016 to February 28, 2020
Death due to alcoholic cardiomyopathy (I42.6)
Nervous system disorders caused by alcohol - Hospitalization
Time frame: January 1, 2016 to February 28, 2020
Incidence of hospitalization due to degeneration of the nervous system due to alcohol, epileptic seizures related to alcohol, alcoholic polyneuropathy, alcoholic myopathy (G312, G4051, G621, G721)
Nervous system disorders caused by alcohol - Death
Time frame: January 1, 2016 to February 28, 2020
Death due to degeneration of the nervous system due to alcohol, epileptic seizures related to alcohol, alcoholic polyneuropathy, alcoholic myopathy (G312, G4051, G621, G721)
Alcohol poisoning - Hospitalization
Time frame: January 1, 2016 to February 28, 2020
Incidence of hospitalization due to alcohol poisoning (T51, X45)
Alcohol poisoning - Death
Time frame: January 1, 2016 to February 28, 2020
Death due to alcohol poisoning (T51, X45)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Background: PubMed 30146330GBD 2016 Alcohol Collaborators. Alcohol use and burden for 195 countries and territories, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2018 Sep 22;392(10152):1015-1035. doi: 10.1016/S0140-6736(18)31310-2. Epub 2018 Aug 23.
- Background: PubMed 33970445Manthey J, Hassan SA, Carr S, Kilian C, Kuitunen-Paul S, Rehm J. What are the Economic Costs to Society Attributable to Alcohol Use? A Systematic Review and Modelling Study. Pharmacoeconomics. 2021 Jul;39(7):809-822. doi: 10.1007/s40273-021-01031-8. Epub 2021 May 10.
- Background: PubMed 20617064Room R, Ferris J, Laslett AM, Livingston M, Mugavin J, Wilkinson C. The drinker's effect on the social environment: a conceptual framework for studying alcohol's harm to others. Int J Environ Res Public Health. 2010 Apr;7(4):1855-71. doi: 10.3390/ijerph7041855. Epub 2010 Apr 21.
- Background: PubMed 34736475Probst C, Lange S, Kilian C, Saul C, Rehm J. The dose-response relationship between socioeconomic deprivation and alcohol-attributable mortality risk-a systematic review and meta-analysis. BMC Med. 2021 Nov 5;19(1):268. doi: 10.1186/s12916-021-02132-z.
- Background: PubMed 32504585Probst C, Kilian C, Sanchez S, Lange S, Rehm J. The role of alcohol use and drinking patterns in socioeconomic inequalities in mortality: a systematic review. Lancet Public Health. 2020 Jun;5(6):e324-e332. doi: 10.1016/S2468-2667(20)30052-9.
- Background: PubMed 28556302Syden L, Sidorchuk A, Makela P, Landberg J. The contribution of alcohol use and other behavioural, material and social factors to socio-economic differences in alcohol-related disorders in a Swedish cohort. Addiction. 2017 Nov;112(11):1920-1930. doi: 10.1111/add.13889. Epub 2017 Jul 17.
- Background: PubMed 18621959Makela P, Paljarvi T. Do consequences of a given pattern of drinking vary by socioeconomic status? A mortality and hospitalisation follow-up for alcohol-related causes of the Finnish Drinking Habits Surveys. J Epidemiol Community Health. 2008 Aug;62(8):728-33. doi: 10.1136/jech.2007.065672.
- Background: PubMed 33404149Pena S, Makela P, Laatikainen T, Harkanen T, Mannisto S, Heliovaara M, Koskinen S. Joint effects of alcohol use, smoking and body mass index as an explanation for the alcohol harm paradox: causal mediation analysis of eight cohort studies. Addiction. 2021 Aug;116(8):2220-2230. doi: 10.1111/add.15395. Epub 2021 Jan 28.
- Background: PubMed 28626829Katikireddi SV, Whitley E, Lewsey J, Gray L, Leyland AH. Socioeconomic status as an effect modifier of alcohol consumption and harm: analysis of linked cohort data. Lancet Public Health. 2017 May 10;2(6):e267-e276. doi: 10.1016/S2468-2667(17)30078-6. eCollection 2017 Jun.
- Background: PubMed 10665076Makela P. Alcohol-related mortality as a function of socio-economic status. Addiction. 1999 Jun;94(6):867-86. doi: 10.1046/j.1360-0443.1999.94686710.x.
- Background: PubMed 32995840Pena S, Makela P, Harkanen T, Heliovaara M, Gunnar T, Mannisto S, Laatikainen T, Vartiainen E, Koskinen S. Measurement error as an explanation for the alcohol harm paradox: analysis of eight cohort studies. Int J Epidemiol. 2021 Jan 23;49(6):1836-1846. doi: 10.1093/ije/dyaa113.
- Background: PubMed 27981670Sadler S, Angus C, Gavens L, Gillespie D, Holmes J, Hamilton J, Brennan A, Meier P. Understanding the alcohol harm paradox: an analysis of sex- and condition-specific hospital admissions by socio-economic group for alcohol-associated conditions in England. Addiction. 2017 May;112(5):808-817. doi: 10.1111/add.13726. Epub 2017 Feb 6.
- Individual participant dataSharing planned: No. The investigators will share the harmonization protocol to define the variables and the statistical code. Individual participant data is available upon request at FinData, following national data protection procedures.
Related trials for Alcohol-Related Disorders
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
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.
Sebastián Peña, MD, PhD principal investigator
Finnish Institute for Health and Welfare
Sonja Lumme, PhD study chair
Finnish Institute for Health and Welfare
Päivikki Koponen, PhD study chair
Finnish Institute for Health and Welfare
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol-Related Disorders, run by Finnish Institute for Health and Welfare.
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 1 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: status not confirmed, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Alcohol intoxication - Hospitalization (time frame: January 1, 2016 to February 28, 2020). The study lists 18 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 NCT05865847, which also lists 14 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 19 May 2023.