Alcohol-Related DisordersNCT01273220
National Epidemiologic Survey on Alcohol and Related Conditions-III
An observational study of Alcohol-Related Disorders, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
Trial summary
Background: Alcohol use disorders are the most prevalent mental disorders in the United States and are a factor in more than 10 percent of all deaths, including heart disease, stroke, and certain types of cancer and chronic illness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol-Related Disorders
- How many people
- 36,309 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2011to 18 Aug 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults, 18 years and older.
- Noninstitutionalized U.S. civilian population living in households.
- Selected noninstitutional group quarters including, vocational training and other dormitories, halfway houses, hostels, YMCAs, shelters, campgrounds, carnivals.
- -Persons who prefer to have their interviews conducted in English, Spanish, and the four most commonly spoken Asian languages in the U.S.
Who cannot join
- Children and adolescents 17 years and younger.
- Military living off base.
- Institutional group quarters including: military living on base, prisons and other correctional facilities; hospitals; nursing homes; hospices; schools; homes or wards for physically handicapped; all juvenile institutions; residential treatment for emotionally disturbed; and homes for abused, dependent and neglected children.
- Persons who prefer to have their interviews conducted in languages other than English, Spanish or the four Asian languages most commonly spoken in the U.S.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute on Alcohol Abuse and Alcoholism (NIAAA), 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: National Epidemiologic Survey on Alcohol and Related Conditions -III
Background:
- Alcohol use disorders are the most prevalent mental disorders in the United States and are a factor in more than 10 percent of all deaths, including heart disease, stroke, and certain types of cancer and chronic illness. Research into better treatment methods for alcohol use disorders and their associated disabilities requires a broad amount of information on the genetic and environmental factors that predispose certain individuals to alcoholism. To improve the quality of available information for research, the National Institutes of Health is conducting a nationwide survey on alcohol use disorders and related physical and mental disabilities, and will collect genetic information through saliva samples.
Read more
Objectives:
- To collect interview data and saliva samples from the U.S. civilian noninstitutionalized population, 18 years and older, in order to study the extent of and contributing factors to alcohol use and abuse in the United States.
Eligibility:
- Individuals at least 18 years of age who do not live in institutions (i.e., prisons, inpatient mental hospitals) and who are willing to be interviewed in English, Spanish, and the four most commonly spoken Asian languages in the United States (e.g., Chinese, Korean).
Design:
- The study will involve three main components: an automated computer-assisted interview, an automated questionnaire, and the collection of a saliva sample.
- Participants will be recruited through community through publically available U.S. Census Bureau files.
- The interview and questionnaire will ask standardized questions related to personal history; alcohol use and possible disorders; symptoms scales of mood, anxiety, and eating conditions that frequently co-occur with alcohol and drug use disorders; tobacco, medicine and drug use and disorders; selected personality traits, including behavior; alcohol, drug, and mental health treatment utilization; and medical conditions related to alcohol consumption.
- Participants will provide a saliva sample for genetic study.
Background:
- Alcohol use disorders are the most prevalent mental disorders in the United States and are a factor in more than 10 percent of all deaths, including heart disease, stroke, and certain types of cancer and chronic illness. Research into better treatment methods for alcohol use disorders and their associated disabilities requires a broad amount of information on the genetic and environmental factors that predispose certain individuals to alcoholism. To improve the quality of available information for research, the National Institutes of Health is conducting a nationwide survey on alcohol use disorders and related physical and mental disabilities, and will collect genetic information through saliva samples.
Objectives:
- To collect interview data and saliva samples from the U.S. civilian noninstitutionalized population, 18 years and older, in order to study the extent of and contributing factors to alcohol use and abuse in the United States.
Eligibility:
- Individuals at least 18 years of age who do not live in institutions (i.e., prisons, inpatient mental hospitals) and who are willing to be interviewed in English, Spanish, and the four most commonly spoken Asian languages in the United States (e.g., Chinese, Korean).
Design:
- The study will involve three main components: an automated computer-assisted interview, an automated questionnaire, and the collection of a saliva sample.
- Participants will be recruited through community through publically available U.S. Census Bureau files.
- The interview and questionnaire will ask standardized questions related to personal history; alcohol use and possible disorders; symptoms scales of mood, anxiety, and eating conditions that frequently co-occur with alcohol and drug use disorders; tobacco, medicine and drug use and disorders; selected personality traits, including behavior; alcohol, drug, and mental health treatment utilization; and medical conditions related to alcohol consumption.
- Participants will provide a saliva sample for genetic study.
Read the detailed description
The National Epidemiologic Survey on Alcohol and Related Conditions-III (NESARC-III) is planned to be fielded in 2012 by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) in conjunction with Westat, through a contract under data collection authority Title 42 U.S.C. 285 n (Attachment 23.a). The target population of the NESARC-III is the civilian noninstitutionalized population, 18 years and older, residing in the contiguous United States (U.S.) and Alaska and Hawaii. The sample (N=46,500) will include households and selected noninstitutionalized group quarters (e.g., agricultural, vocational training and other dormitories, halfway houses, hostels, YMCAs, shelters, campgrounds, carnivals). The NESARC-III will collect information on alcohol use disorders and related physical and mental disabilities in addition to DNA to be obtained through saliva samples.
This request for IRB approval also includes a pilot test of approximately 50 respondents that will serve the sole purpose of testing the data collection procedures, operations and system architecture of the NESARC-III survey. There will also be two small methodological subcomponents of the NESARC-III proper that will serve the purposes of providing ongoing validation and assessment of the utility of outcome measures appearing on the major data collection questionnaire, the Alcohol Use Disorder and Associated Disabilities Interview Schedule-V (AUDADIS-V: Grant et al., 2008). In the first methodological subcomponent, 1000 respondents participating in the NESARC-III proper will be re-interviewed with a shorter version of the original AUDADIS-V. In the second methodological subcomponent, 700 different respondents participating in the NESARC-III proper will be re-interviewed using a different assessment instrument, the Psychiatric Research Interview for Substance and Mental Disorders (PRISM: Hasin et al., 2008), covering information on major outcome variables very similar to those appearing in the AUDADIS-V. NIAAA has conducted such validation/utility tests that have received OMB approval (OMB No. 0930-0151, OMB No. 0925-0455: Grant et al., 2003a; Ruan et al., 2008) in the past. The design and procedures associated with each of these methodological subcomponents will be explicated and discussed within the body of this IRB submission as necessary.
The NESARC-III will be the fourth national survey conducted by NIAAA. The objectives and content areas of the NESARC-III are extremely similar to those of the prior three NIAAA surveys, with the exception of the NESARC-III s provision for collecting saliva samples. Prior NIAAA national surveys included the 1991-1992 National Longitudinal Alcohol Epidemiologic Survey (OMB No. 0930-0151: Grant et al., 1994), the 2001-2002 Wave 1 NESARC (OMB No. 0925-0484: Grant et al., 2003b), and the 2004-2005 Wave 2 NESARC (OMB No. 0925-0484: Grant et al., 2006).
- Conditions
- Alcohol-Related Disorders
- Keywords
- Epidemiology, Epidemiologic Survey, Alcohol
- Medical subject headings
- Alcohol-Related Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of alcohol and drug use practices
Alcohol and drug use disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2011 (estimated)
- Study start7 Jan 2011
- Primary completion26 Sep 2013
- Study completion18 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Time perspective
- Retrospective
- Enrolment
- 36,309 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Tulshi D Saha, Ph.D., Principal investigator, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01273220
- Sponsor's protocol ID
- 999911056
- Other IDs
- 11-AA-N056
- Status last verified
- Aug 2020
- First submitted
- 7 Jan 2011
- Last updated
- 21 Aug 2020
- Results posted
- No
Publications
Hasin DS, Stinson FS, Ogburn E, Grant BF. Prevalence, correlates, disability, and comorbidity of DSM-IV alcohol abuse and dependence in the United States: results from the National Epidemiologic Survey on Alcohol and Related Conditions. Arch Gen Psychiatry. 2007 Jul;64(7):830-42. doi: 10.1001/archpsyc.64.7.830.
PubMed 17606817Grant BF, Dawson DA, Stinson FS, Chou PS, Kay W, Pickering R. The Alcohol Use Disorder and Associated Disabilities Interview Schedule-IV (AUDADIS-IV): reliability of alcohol consumption, tobacco use, family history of depression and psychiatric diagnostic modules in a general population sample. Drug Alcohol Depend. 2003 Jul 20;71(1):7-16. doi: 10.1016/s0376-8716(03)00070-x.
PubMed 12821201Ruan WJ, Goldstein RB, Chou SP, Smith SM, Saha TD, Pickering RP, Dawson DA, Huang B, Stinson FS, Grant BF. The alcohol use disorder and associated disabilities interview schedule-IV (AUDADIS-IV): reliability of new psychiatric diagnostic modules and risk factors in a general population sample. Drug Alcohol Depend. 2008 Jan 1;92(1-3):27-36. doi: 10.1016/j.drugalcdep.2007.06.001. Epub 2007 Aug 13.
PubMed 17706375
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Epidemiologic Survey on Alcohol and Related Conditions -III
- ClinicalTrials.gov ID
- NCT01273220
- Acronym / sponsor ID
- 999911056
- Conditions
- Alcohol-Related Disorders
- Keywords
- Epidemiology, Epidemiologic Survey, Alcohol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36,309 participants (actual)
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- Study start
- 7 Jan 2011 (actual)
- Primary completion
- 26 Sep 2013 (actual)
- Study completion
- 18 Aug 2020 (actual)
- First posted
- 10 Jan 2011 (estimated)
- 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.
Background:
- Alcohol use disorders are the most prevalent mental disorders in the United States and are a factor in more than 10 percent of all deaths, including heart disease, stroke, and certain types of cancer and chronic illness. Research into better treatment methods for alcohol use disorders and their associated disabilities requires a broad amount of information on the genetic and environmental factors that predispose certain individuals to alcoholism. To improve the quality of available information for research, the National Institutes of Health is conducting a nationwide survey on alcohol use disorders and related physical and mental disabilities, and will collect genetic information through saliva samples.
Objectives:
- To collect interview data and saliva samples from the U.S. civilian noninstitutionalized population, 18 years and older, in order to study the extent of and contributing factors to alcohol use and abuse in the United States.
Eligibility:
- Individuals at least 18 years of age who do not live in institutions (i.e., prisons, inpatient mental hospitals) and who are willing to be interviewed in English, Spanish, and the four most commonly spoken Asian languages in the United States (e.g., Chinese, Korean).
Design:
- The study will involve three main components: an automated computer-assisted interview, an automated questionnaire, and the collection of a saliva sample.
- Participants will be recruited through community through publically available U.S. Census Bureau files.
- The interview and questionnaire will ask standardized questions related to personal history; alcohol use and possible disorders; symptoms scales of mood, anxiety, and eating conditions that frequently co-occur with alcohol and drug use disorders; tobacco, medicine and drug use and disorders; selected personality traits, including behavior; alcohol, drug, and mental health treatment utilization; and medical conditions related to alcohol consumption.
- Participants will provide a saliva sample for genetic study.
Background:
- Alcohol use disorders are the most prevalent mental disorders in the United States and are a factor in more than 10 percent of all deaths, including heart disease, stroke, and certain types of cancer and chronic illness. Research into better treatment methods for alcohol use disorders and their associated disabilities requires a broad amount of information on the genetic and environmental factors that predispose certain individuals to alcoholism. To improve the quality of available information for research, the National Institutes of Health is conducting a nationwide survey on alcohol use disorders and related physical and mental disabilities, and will collect genetic information through saliva samples.
Objectives:
- To collect interview data and saliva samples from the U.S. civilian noninstitutionalized population, 18 years and older, in order to study the extent of and contributing factors to alcohol use and abuse in the United States.
Eligibility:
- Individuals at least 18 years of age who do not live in institutions (i.e., prisons, inpatient mental hospitals) and who are willing to be interviewed in English, Spanish, and the four most commonly spoken Asian languages in the United States (e.g., Chinese, Korean).
Design:
- The study will involve three main components: an automated computer-assisted interview, an automated questionnaire, and the collection of a saliva sample.
- Participants will be recruited through community through publically available U.S. Census Bureau files.
- The interview and questionnaire will ask standardized questions related to personal history; alcohol use and possible disorders; symptoms scales of mood, anxiety, and eating conditions that frequently co-occur with alcohol and drug use disorders; tobacco, medicine and drug use and disorders; selected personality traits, including behavior; alcohol, drug, and mental health treatment utilization; and medical conditions related to alcohol consumption.
- Participants will provide a saliva sample for genetic study.
Detailed description
The National Epidemiologic Survey on Alcohol and Related Conditions-III (NESARC-III) is planned to be fielded in 2012 by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) in conjunction with Westat, through a contract under data collection authority Title 42 U.S.C. 285 n (Attachment 23.a). The target population of the NESARC-III is the civilian noninstitutionalized population, 18 years and older, residing in the contiguous United States (U.S.) and Alaska and Hawaii. The sample (N=46,500) will include households and selected noninstitutionalized group quarters (e.g., agricultural, vocational training and other dormitories, halfway houses, hostels, YMCAs, shelters, campgrounds, carnivals). The NESARC-III will collect information on alcohol use disorders and related physical and mental disabilities in addition to DNA to be obtained through saliva samples.
This request for IRB approval also includes a pilot test of approximately 50 respondents that will serve the sole purpose of testing the data collection procedures, operations and system architecture of the NESARC-III survey. There will also be two small methodological subcomponents of the NESARC-III proper that will serve the purposes of providing ongoing validation and assessment of the utility of outcome measures appearing on the major data collection questionnaire, the Alcohol Use Disorder and Associated Disabilities Interview Schedule-V (AUDADIS-V: Grant et al., 2008). In the first methodological subcomponent, 1000 respondents participating in the NESARC-III proper will be re-interviewed with a shorter version of the original AUDADIS-V. In the second methodological subcomponent, 700 different respondents participating in the NESARC-III proper will be re-interviewed using a different assessment instrument, the Psychiatric Research Interview for Substance and Mental Disorders (PRISM: Hasin et al., 2008), covering information on major outcome variables very similar to those appearing in the AUDADIS-V. NIAAA has conducted such validation/utility tests that have received OMB approval (OMB No. 0930-0151, OMB No. 0925-0455: Grant et al., 2003a; Ruan et al., 2008) in the past. The design and procedures associated with each of these methodological subcomponents will be explicated and discussed within the body of this IRB submission as necessary.
The NESARC-III will be the fourth national survey conducted by NIAAA. The objectives and content areas of the NESARC-III are extremely similar to those of the prior three NIAAA surveys, with the exception of the NESARC-III s provision for collecting saliva samples. Prior NIAAA national surveys included the 1991-1992 National Longitudinal Alcohol Epidemiologic Survey (OMB No. 0930-0151: Grant et al., 1994), the 2001-2002 Wave 1 NESARC (OMB No. 0925-0484: Grant et al., 2003b), and the 2004-2005 Wave 2 NESARC (OMB No. 0925-0484: Grant et al., 2006).
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults, 18 years and older.
- Noninstitutionalized U.S. civilian population living in households.
- Selected noninstitutional group quarters including, vocational training and other dormitories, halfway houses, hostels, YMCAs, shelters, campgrounds, carnivals.
- -Persons who prefer to have their interviews conducted in English, Spanish, and the four most commonly spoken Asian languages in the U.S.
Key exclusion criteria (4 listed)
- Children and adolescents 17 years and younger.
- Military living off base.
- Institutional group quarters including: military living on base, prisons and other correctional facilities; hospitals; nursing homes; hospices; schools; homes or wards for physically handicapped; all juvenile institutions; residential treatment for emotionally disturbed; and homes for abused, dependent and neglected children.
- Persons who prefer to have their interviews conducted in languages other than English, Spanish or the four Asian languages most commonly spoken in the U.S.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The prevalence of alcohol and drug use practices
Alcohol and drug use disorders
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 21 Aug 2020.
- Background: PubMed 17606817Hasin DS, Stinson FS, Ogburn E, Grant BF. Prevalence, correlates, disability, and comorbidity of DSM-IV alcohol abuse and dependence in the United States: results from the National Epidemiologic Survey on Alcohol and Related Conditions. Arch Gen Psychiatry. 2007 Jul;64(7):830-42. doi: 10.1001/archpsyc.64.7.830.
- Background: PubMed 12821201Grant BF, Dawson DA, Stinson FS, Chou PS, Kay W, Pickering R. The Alcohol Use Disorder and Associated Disabilities Interview Schedule-IV (AUDADIS-IV): reliability of alcohol consumption, tobacco use, family history of depression and psychiatric diagnostic modules in a general population sample. Drug Alcohol Depend. 2003 Jul 20;71(1):7-16. doi: 10.1016/s0376-8716(03)00070-x.
- Background: PubMed 17706375Ruan WJ, Goldstein RB, Chou SP, Smith SM, Saha TD, Pickering RP, Dawson DA, Huang B, Stinson FS, Grant BF. The alcohol use disorder and associated disabilities interview schedule-IV (AUDADIS-IV): reliability of new psychiatric diagnostic modules and risk factors in a general population sample. Drug Alcohol Depend. 2008 Jan 1;92(1-3):27-36. doi: 10.1016/j.drugalcdep.2007.06.001. Epub 2007 Aug 13.
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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.
Tulshi D Saha, Ph.D. principal investigator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol-Related Disorders, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
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 4 inclusion and 4 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 21 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The prevalence of alcohol and drug use practices. The study lists 2 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 NCT01273220, which also lists 3 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 21 Aug 2020.