Alcohol Use DisorderNCT02231840
NIAAA Natural History Protocol
An observational study of Alcohol Use Disorder, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
Trial summary
Background: About 17 million adults had an alcohol use disorder in 2012. Researchers want to follow people that have alcohol problems and want treatment, as well as those who do not want treatment and healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- How many people
- 7,500 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2015to 31 Dec 2044
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We will enroll a total of 7500 participants. Any individual (Bullet)18 years of age who expresses interest in participating in this study and/or other research studies offered at NIAAA during the brief telephone pre-screening may be enrolled. Participants may be individuals with no current or past AUD, as well as individuals who meet current or past DSM criteria for AUD. Healthy volunteers and other volunteers will also be enrolled in this protocol.
Who may be able to join
- As this is a natural history protocol of alcohol use as a continuum, in order to be eligible to participate in this study, an individual must meet the following criterion:
- Age >=18 years of age
- Willingness to complete the study including genetic and MRI tests.
- We will assign participants to one of two groups in this study:
- Treatment-seeking individuals (Patients that want to stop alcohol use and will require medical management to achieve sobriety) and
- Non-treatment-seeking participants (Patients or healthy volunteers who want to continue their current alcohol use).
- All participants are initially phone-screened for eligibility and their desire for treatment of AUD (or lack of it) will determine their group allocation. Their self-report of health status, pregnancy, legal status, and willingness to complete the study including the genetics and MRI test will be assessed in the phone screen and determine eligibility.
Who cannot join
- This is a natural history protocol of alcohol use as a continuum. Potential participants are pre-screened on the phone and, based on the information provided on the phone, the following categories are excluded because they are not suitable study participants for this protocol:
- Individuals < 18 years of age
- Prisoners
- Pregnant candidates
- Candidates having a severe medical or mental health disorder that would impair participation in the study
- All participants are initially phone-screened for eligibility: age, legal status, pregnancy, and severe medical conditions will be assessed using information reported in the phone screen to determine eligibility for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Background:
- About 17 million adults had an alcohol use disorder in 2012. Researchers want to follow people that have alcohol problems and want treatment, as well as those who do not want treatment and healthy volunteers. They also want to gather information on people with and without alcohol problems, including information on genes and biological processes in the body.. This will help them better understand, prevent, and treat alcohol problems.
Read more
Objective:
-To look at a broad range of traits in people who are healthy people and people with alcohol problems. To study them for potential eligibility for other research protocols conducted at the NIH Clinical Center.
Eligibility:
- Adults age 18 and older.
- Not being pregnant or imprisoned.
Design:
- Participants will have a physical exam. They will answer questions about their health and alcohol and drug use. They will have an electrocardiogram to check their heart. They will have blood, urine, and breath alcohol tests.
- Participants without alcohol problems, or who have them but do not want treatment, can sign the second consent for screening and research.
- Participants that have alcohol problems and want treatment will be treated at the NIH Clinical Center. They will be offered to sign the second consent at a later time.
- Participants may join an inpatient treatment and detox program. It could last up to 6 weeks. Or they may join an outpatient program. Some may do both.
- After discharge, participants may be called and asked questions about their drinking and health.
- If participants sign the second consent, they:
- will complete paper- and computer-based questionnaires.
- will give blood samples.
- may have a brain scan using magnetic resonance imaging. They will lie on a table that slides in and out of a cylinder that takes pictures. The machine makes loud noises. They will get earplugs.
Read the detailed description
Study Description:
This study represents the natural history protocol for NIAAA with the main objectives of providing deep phenotyping of patients across the alcohol use spectrum. This includes Alcohol Use Disorders (AUD) patients, patients with problematic drinking, social drinking, and patients who are abstinent (healthy volunteers, and other volunteers). We have two groups in this study. Treatment-seeking individuals (Patients that want to stop alcohol use and will require medical management to achieve sobriety) and non-treatment-seeking participants (Patients who want to continue their current alcohol use). A standard set of data will be collected in all patients allowing us to study the impact of alcohol use in their overall health.
Primary Objective:
To gather a set of characterization measures, including a standardized dataset of clinical, behavioral, biochemical, and structural MRI-based phenotypic assessments, as well as whole genome genotypes.
Primary Endpoint:
A standardized set of data collected consistently under this protocol that will allow exploratory, descriptive, or correlational studies of alcohol use and AUD.
- Conditions
- Alcohol Use Disorder
- Keywords
- Phenotypes, Genetics, Alcohol Use Disorder, Natural History
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Not treatment-seeking participants | Individuals who meet current or past DSM 5 criteria for AUD but are not seeking treatment. Healthy volunteers and other volunteers. | |
| Treatment-seeking Patients | Individuals who meet current DSM 5 criteria for AUD and are seeking treatment for it. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obtain phenotypic assessments
To gather characterization measures for individuals wishing to participate in this protocol, including a standardized set of clinical, behavioral, biochemical, and structural MRI-based phenotypic assessments, as well as whole genome genotypes
Measured: CROSS SECTIONAL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2014 (estimated)
- Study start21 Jan 2015
- Primary completion31 Dec 2044 (estimated)
- Study completion31 Dec 2044 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 7,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Nancy Diazgranados, M.D., Principal investigator, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02231840
- Sponsor's protocol ID
- 140181
- Other IDs
- 14-AA-0181
- Status last verified
- 22 Oct 2026
- First submitted
- 3 Sep 2014
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IDP, identifiable specimens and data from this protocol will be shared with other NIH protocols for future research, so that data collected under different studies from a single individual may be combined for analysis after IRB approval and informed consent (or waiver of consent) for the use of the data for the research is in place. Data will be shared from two locations: @@@1) The NIH Clinical Center Clinical Research Information System (CRIS) system, where we routinely store clinical patient data and implement adequate privacy protections by design; @@@2) On access controlled NIAAA servers, located in secured space to prevent physical theft of storage media, and managed by NIAAA IT in agreement with NIH data security policies. We will feed some of the data residing in CRIS and on the NIAAA servers to the NIH Biomedical Translational Research Information System (BTRIS).@@@
Publications
Kwako LE, Schwandt ML, Ramchandani VA, Diazgranados N, Koob GF, Volkow ND, Blanco C, Goldman D. Neurofunctional Domains Derived From Deep Behavioral Phenotyping in Alcohol Use Disorder. Am J Psychiatry. 2019 Sep 1;176(9):744-753. doi: 10.1176/appi.ajp.2018.18030357. Epub 2019 Jan 4.
PubMed 30606047Antonello PC, Hodgkinson CA, Feng D, Marietta C, Mohana Krishnan B, Parra MA, Sun Z, Gao B, Goldman D, Antoine MW. Genetic regulation of AIF1 shapes immune and liver injury profiles in chronic alcohol use. JCI Insight. 2026 Mar 10;11(8):e198209. doi: 10.1172/jci.insight.198209. eCollection 2026 Apr 22.
PubMed 41838574Cullins EC, Gunawan T, Schwandt ML, Luk JW, George DT, Diazgranados N, Goldman D, Ramchandani VA. Markers of Negative Emotionality in Individuals With Comorbid Alcohol Use Disorder and Post-Traumatic Stress Disorder: Role of Childhood Trauma. Addict Biol. 2025 Apr;30(4):e70037. doi: 10.1111/adb.70037.
PubMed 40250452Thompson MF, Schwandt ML, Ramchandani VA, Diazgranados N, Goldman D, Luk JW. Stress and alcohol-related coping mechanisms linking lifetime suicide ideation and attempt to multidimensional quality of life. J Affect Disord. 2024 Apr 15;351:729-737. doi: 10.1016/j.jad.2024.01.209. Epub 2024 Jan 27.
PubMed 38281600
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIAAA Natural History Protocol
- ClinicalTrials.gov ID
- NCT02231840
- Acronym / sponsor ID
- 140181
- Conditions
- Alcohol Use Disorder
- Keywords
- Phenotypes, Genetics, Alcohol Use Disorder, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 7,500 participants (estimated)
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- Study start
- 21 Jan 2015 (actual)
- Primary completion
- 31 Dec 2044 (estimated)
- Study completion
- 31 Dec 2044 (estimated)
- First posted
- 4 Sep 2014 (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:
- About 17 million adults had an alcohol use disorder in 2012. Researchers want to follow people that have alcohol problems and want treatment, as well as those who do not want treatment and healthy volunteers. They also want to gather information on people with and without alcohol problems, including information on genes and biological processes in the body.. This will help them better understand, prevent, and treat alcohol problems.
Objective:
-To look at a broad range of traits in people who are healthy people and people with alcohol problems. To study them for potential eligibility for other research protocols conducted at the NIH Clinical Center.
Eligibility:
- Adults age 18 and older.
- Not being pregnant or imprisoned.
Design:
- Participants will have a physical exam. They will answer questions about their health and alcohol and drug use. They will have an electrocardiogram to check their heart. They will have blood, urine, and breath alcohol tests.
- Participants without alcohol problems, or who have them but do not want treatment, can sign the second consent for screening and research.
- Participants that have alcohol problems and want treatment will be treated at the NIH Clinical Center. They will be offered to sign the second consent at a later time.
- Participants may join an inpatient treatment and detox program. It could last up to 6 weeks. Or they may join an outpatient program. Some may do both.
- After discharge, participants may be called and asked questions about their drinking and health.
- If participants sign the second consent, they:
- will complete paper- and computer-based questionnaires.
- will give blood samples.
- may have a brain scan using magnetic resonance imaging. They will lie on a table that slides in and out of a cylinder that takes pictures. The machine makes loud noises. They will get earplugs.
Detailed description
Study Description:
This study represents the natural history protocol for NIAAA with the main objectives of providing deep phenotyping of patients across the alcohol use spectrum. This includes Alcohol Use Disorders (AUD) patients, patients with problematic drinking, social drinking, and patients who are abstinent (healthy volunteers, and other volunteers). We have two groups in this study. Treatment-seeking individuals (Patients that want to stop alcohol use and will require medical management to achieve sobriety) and non-treatment-seeking participants (Patients who want to continue their current alcohol use). A standard set of data will be collected in all patients allowing us to study the impact of alcohol use in their overall health.
Primary Objective:
To gather a set of characterization measures, including a standardized dataset of clinical, behavioral, biochemical, and structural MRI-based phenotypic assessments, as well as whole genome genotypes.
Primary Endpoint:
A standardized set of data collected consistently under this protocol that will allow exploratory, descriptive, or correlational studies of alcohol use and AUD.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Not treatment-seeking participants | – | –Individuals who meet current or past DSM 5 criteria for AUD but are not seeking treatment. Healthy volunteers and other volunteers. |
| Treatment-seeking Patients | – | –Individuals who meet current DSM 5 criteria for AUD and are seeking treatment for it. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We will enroll a total of 7500 participants. Any individual (Bullet)18 years of age who expresses interest in participating in this study and/or other research studies offered at NIAAA during the brief telephone pre-screening may be enrolled. Participants may be individuals with no current or past AUD, as well as individuals who meet current or past DSM criteria for AUD. Healthy volunteers and other volunteers will also be enrolled in this protocol.
Key inclusion criteria (7 listed)
- As this is a natural history protocol of alcohol use as a continuum, in order to be eligible to participate in this study, an individual must meet the following criterion:
- Age >=18 years of age
- Willingness to complete the study including genetic and MRI tests.
- Treatment-seeking individuals (Patients that want to stop alcohol use and will require medical management to achieve sobriety) and
- Non-treatment-seeking participants (Patients or healthy volunteers who want to continue their current alcohol use).
Key exclusion criteria (6 listed)
- This is a natural history protocol of alcohol use as a continuum. Potential participants are pre-screened on the phone and, based on the information provided on the phone, the following categories are excluded because they are not suitable study participants for this protocol:
- Individuals < 18 years of age
- Prisoners
- Pregnant candidates
- Candidates having a severe medical or mental health disorder that would impair participation in the study
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
Obtain phenotypic assessments
Time frame: CROSS SECTIONAL
To gather characterization measures for individuals wishing to participate in this protocol, including a standardized set of clinical, behavioral, biochemical, and structural MRI-based phenotypic assessments, as well as whole genome genotypes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 30606047Kwako LE, Schwandt ML, Ramchandani VA, Diazgranados N, Koob GF, Volkow ND, Blanco C, Goldman D. Neurofunctional Domains Derived From Deep Behavioral Phenotyping in Alcohol Use Disorder. Am J Psychiatry. 2019 Sep 1;176(9):744-753. doi: 10.1176/appi.ajp.2018.18030357. Epub 2019 Jan 4.
- Derived from this study: PubMed 41838574Antonello PC, Hodgkinson CA, Feng D, Marietta C, Mohana Krishnan B, Parra MA, Sun Z, Gao B, Goldman D, Antoine MW. Genetic regulation of AIF1 shapes immune and liver injury profiles in chronic alcohol use. JCI Insight. 2026 Mar 10;11(8):e198209. doi: 10.1172/jci.insight.198209. eCollection 2026 Apr 22.
- Derived from this study: PubMed 40250452Cullins EC, Gunawan T, Schwandt ML, Luk JW, George DT, Diazgranados N, Goldman D, Ramchandani VA. Markers of Negative Emotionality in Individuals With Comorbid Alcohol Use Disorder and Post-Traumatic Stress Disorder: Role of Childhood Trauma. Addict Biol. 2025 Apr;30(4):e70037. doi: 10.1111/adb.70037.
- Derived from this study: PubMed 38281600Thompson MF, Schwandt ML, Ramchandani VA, Diazgranados N, Goldman D, Luk JW. Stress and alcohol-related coping mechanisms linking lifetime suicide ideation and attempt to multidimensional quality of life. J Affect Disord. 2024 Apr 15;351:729-737. doi: 10.1016/j.jad.2024.01.209. Epub 2024 Jan 27.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IDP, identifiable specimens and data from this protocol will be shared with other NIH protocols for future research, so that data collected under different studies from a single individual may be combined for analysis after IRB approval and informed consent (or waiver of consent) for the use of the data for the research is in place. Data will be shared from two locations: @@@1) The NIH Clinical Center Clinical Research Information System (CRIS) system, where we routinely store clinical patient data and implement adequate privacy protections by design; @@@2) On access controlled NIAAA servers, located in secured space to prevent physical theft of storage media, and managed by NIAAA IT in agreement with NIH data security policies. We will feed some of the data residing in CRIS and on the NIAAA servers to the NIH Biomedical Translational Research Information System (BTRIS).@@@
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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.
Nancy Diazgranados, M.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 Use Disorder, 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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beth A Lee, R.N. ((301) 451-6964, beth.lee@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obtain phenotypic assessments (time frame: CROSS SECTIONAL). 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 NCT02231840, which also lists 4 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 26 Oct 2026.